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1.  Sleep-Disordered Breathing and Mortality: A Prospective Cohort Study 
PLoS Medicine  2009;6(8):e1000132.
In a cohort of 6,441 volunteers followed over an average of 8.2 years, Naresh Punjabi and colleagues find sleep-disordered breathing to be independently associated with mortality and identify predictive characteristics.
Background
Sleep-disordered breathing is a common condition associated with adverse health outcomes including hypertension and cardiovascular disease. The overall objective of this study was to determine whether sleep-disordered breathing and its sequelae of intermittent hypoxemia and recurrent arousals are associated with mortality in a community sample of adults aged 40 years or older.
Methods and Findings
We prospectively examined whether sleep-disordered breathing was associated with an increased risk of death from any cause in 6,441 men and women participating in the Sleep Heart Health Study. Sleep-disordered breathing was assessed with the apnea–hypopnea index (AHI) based on an in-home polysomnogram. Survival analysis and proportional hazards regression models were used to calculate hazard ratios for mortality after adjusting for age, sex, race, smoking status, body mass index, and prevalent medical conditions. The average follow-up period for the cohort was 8.2 y during which 1,047 participants (587 men and 460 women) died. Compared to those without sleep-disordered breathing (AHI: <5 events/h), the fully adjusted hazard ratios for all-cause mortality in those with mild (AHI: 5.0–14.9 events/h), moderate (AHI: 15.0–29.9 events/h), and severe (AHI: ≥30.0 events/h) sleep-disordered breathing were 0.93 (95% CI: 0.80–1.08), 1.17 (95% CI: 0.97–1.42), and 1.46 (95% CI: 1.14–1.86), respectively. Stratified analyses by sex and age showed that the increased risk of death associated with severe sleep-disordered breathing was statistically significant in men aged 40–70 y (hazard ratio: 2.09; 95% CI: 1.31–3.33). Measures of sleep-related intermittent hypoxemia, but not sleep fragmentation, were independently associated with all-cause mortality. Coronary artery disease–related mortality associated with sleep-disordered breathing showed a pattern of association similar to all-cause mortality.
Conclusions
Sleep-disordered breathing is associated with all-cause mortality and specifically that due to coronary artery disease, particularly in men aged 40–70 y with severe sleep-disordered breathing.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
About 1 in 10 women and 1 in 4 men have a chronic condition called sleep-disordered breathing although most are unaware of their problem. Sleep-disordered breathing, which is commonest in middle-aged and elderly people, is characterized by numerous, brief (10 second or so) interruptions of breathing during sleep. These interruptions, which usually occur when relaxation of the upper airway muscles decreases airflow, lower the level of oxygen in the blood and, as a result, affected individuals are frequently aroused from deep sleep as they struggle to breathe. Symptoms of sleep-disordered breathing include loud snoring and daytime sleepiness. Treatments include lifestyle changes such as losing weight (excess fat around the neck increases airway collapse) and smoking cessation. Affected people can also use special devices to prevent them sleeping on their backs, but for severe sleep-disordered breathing, doctors often recommend continuous positive airway pressure (CPAP), a machine that pressurizes the upper airway through a face mask to keep it open.
Why Was This Study Done?
Sleep-disordered breathing is a serious condition. It is associated with several adverse health conditions including coronary artery disease (narrowing of the blood vessels that supply the heart, a condition that can cause a heart attack) and daytime sleepiness that can affect an individual's driving ability. In addition, several clinic- and community-based studies suggest that sleep-disordered sleeping may increase a person's risk of dying. However, because these studies have been small and have often failed to allow for other conditions and characteristics that affect an individual's risk of dying (“confounding factors”), they provide inconsistent or incomplete information about the potential association between sleep-disordered breathing and the risk of death. In this prospective cohort study (part of the Sleep Heart Health Study, which is researching the effects of sleep-disordered breathing on cardiovascular health), the researchers examine whether sleep-disordered breathing is associated with all-cause mortality (death from any cause) in a large community sample of adults. A prospective cohort study is one in which a group of participants is enrolled and then followed forward in time (in this case for several years) to see what happens to them.
What Did the Researchers Do and Find?
At enrollment, the study participants—more than 6,000 people aged 40 years or older, none of whom were being treated for sleep-disordered breathing—had a health examination. Their night-time breathing, sleep patterns, and blood oxygen levels were also assessed and these data used to calculate each participant's apnea-hypopnea index (AHI)—the number of apneas and hypopneas per hour. During the study follow-up period, 1,047 participants died. Compared to participants without sleep-disordered sleeping, participants with severe sleep-disordered breathing (an AHI of ≥30) were about one and a half times as likely to die from any cause after adjustment for potential confounding factors. People with milder sleep-disordered breathing did not have a statistically significant increased risk of dying. After dividing the participants into subgroups according to their age and sex, men aged 40–70 years with severe sleep-disordered breathing had a statistically increased risk of dying from any cause (twice the risk of men of a similar age without sleep-disordered breathing). Finally, death from coronary artery disease was also associated with sleep-disordered breathing in men but not in women.
What Do These Findings Mean?
These findings indicate that sleep-disordered breathing is associated with an increased risk of all-cause mortality, particularly in men aged 40–70 years, even after allowing for known confounding factors. They also suggest that the increased risk of death is specifically associated with coronary artery disease although further studies are needed to confirm this finding because it was based on the analysis of a small subgroup of study participants. Although this study is much larger than previous investigations into the association between sleep-disordered breathing and all-cause mortality, it has several limitations including its reliance on a single night's measurements for the diagnosis of sleep-disordered breathing. Nevertheless, these findings suggest that clinical trials should now be started to assess whether treatment can reduce the increased risk of death that seems to be associated with this common disorder.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000132.
The US National Heart Lung and Blood Institute has information (including a video) about sleep-disordered breathing (sleep apnea) (in English and Spanish)
The UK National Heath Service also provides information for patients about sleep apnea
MedlinePlus provides links to further information and advice about sleep-disordered breathing (in English and Spanish)
More information on the Sleep Heart Health Study is available
doi:10.1371/journal.pmed.1000132
PMCID: PMC2722083  PMID: 19688045
2.  A Systematic Review and Meta-Analysis of Utility-Based Quality of Life in Chronic Kidney Disease Treatments 
PLoS Medicine  2012;9(9):e1001307.
Melanie Wyld and colleagues examined previously published studies to assess pooled utility-based quality of life of the various treatments for chronic kidney disease. They conclude that the highest utility was for kidney transplants, with home-based automated peritoneal dialysis being second.
Background
Chronic kidney disease (CKD) is a common and costly condition to treat. Economic evaluations of health care often incorporate patient preferences for health outcomes using utilities. The objective of this study was to determine pooled utility-based quality of life (the numerical value attached to the strength of an individual's preference for a specific health outcome) by CKD treatment modality.
Methods and Findings
We conducted a systematic review, meta-analysis, and meta-regression of peer-reviewed published articles and of PhD dissertations published through 1 December 2010 that reported utility-based quality of life (utility) for adults with late-stage CKD. Studies reporting utilities by proxy (e.g., reported by a patient's doctor or family member) were excluded.
In total, 190 studies reporting 326 utilities from over 56,000 patients were analysed. There were 25 utilities from pre-treatment CKD patients, 226 from dialysis patients (haemodialysis, n = 163; peritoneal dialysis, n = 44), 66 from kidney transplant patients, and three from patients treated with non-dialytic conservative care. Using time tradeoff as a referent instrument, kidney transplant recipients had a mean utility of 0.82 (95% CI: 0.74, 0.90). The mean utility was comparable in pre-treatment CKD patients (difference = −0.02; 95% CI: −0.09, 0.04), 0.11 lower in dialysis patients (95% CI: −0.15, −0.08), and 0.2 lower in conservative care patients (95% CI: −0.38, −0.01). Patients treated with automated peritoneal dialysis had a significantly higher mean utility (0.80) than those on continuous ambulatory peritoneal dialysis (0.72; p = 0.02). The mean utility of transplant patients increased over time, from 0.66 in the 1980s to 0.85 in the 2000s, an increase of 0.19 (95% CI: 0.11, 0.26). Utility varied by elicitation instrument, with standard gamble producing the highest estimates, and the SF-6D by Brazier et al., University of Sheffield, producing the lowest estimates. The main limitations of this study were that treatment assignments were not random, that only transplant had longitudinal data available, and that we calculated EuroQol Group EQ-5D scores from SF-36 and SF-12 health survey data, and therefore the algorithms may not reflect EQ-5D scores measured directly.
Conclusions
For patients with late-stage CKD, treatment with dialysis is associated with a significant decrement in quality of life compared to treatment with kidney transplantation. These findings provide evidence-based utility estimates to inform economic evaluations of kidney therapies, useful for policy makers and in individual treatment discussions with CKD patients.
Editors' Summary
Background
Ill health can adversely affect an individual's quality of life, particularly if caused by long-term (chronic) conditions, such as chronic kidney disease—in the United States alone, 23 million people have chronic kidney disease, of whom 570,000 are treated with dialysis or kidney transplantation. In order to measure the cost-effectiveness of interventions to manage medical conditions, health economists use an objective measurement known as quality-adjusted life years. However, although useful, quality-adjusted life years are often criticized for not taking into account the views and preferences of the individuals with the medical conditions. A measurement called a utility solves this problem. Utilities are a numerical value (measured on a 0 to 1 scale, where 0 represents death and 1 represents full health) of the strength of an individual's preference for specified health-related outcomes, as measured by “instruments” (questionnaires) that rate direct comparisons or assess quality of life.
Why Was This Study Done?
Previous studies have suggested that, in people with chronic kidney disease, quality of life (as measured by utility) is higher in those with a functioning kidney transplant than in those on dialysis. However, currently, it is unclear whether the type of dialysis affects quality of life: hemodialysis is a highly technical process that directly filters the blood, usually must be done 2–4 times a week, and can only be performed in a health facility; peritoneal dialysis, in which fluids are infused into the abdominal cavity, can be done nightly at home (automated peritoneal dialysis) or throughout the day (continuous ambulatory peritoneal dialysis). In this study, the researchers reviewed and assimilated all of the available evidence to investigate whether quality of life in people with chronic kidney disease (as measured by utility) differed according to treatment type.
What Did the Researchers Do and Find?
The researchers did a comprehensive search of 11 databases to identify all relevant studies that included people with severe (stage 3, 4, or 5) chronic kidney disease, their form of treatment, and information on utilities—either reported directly, or included in quality of life instruments (SF-36), so the researchers could calculate utilities by using a validated algorithm. The researchers also recorded the prevalence rates of diabetes in study participants. Then, using statistical models that adjusted for various factors, including treatment type and the method of measuring utilities, the researchers were able to calculate the pooled utilities of each form of treatment for chronic kidney disease.
The researchers included 190 studies, representing over 56,000 patients and generating 326 utility estimates, in their analysis. The majority of utilities (77%) were derived through the SF-36 questionnaire via calculation. Of the 326 utility estimates, 25 were from patients pre-dialysis, 226 were from dialysis patients (the majority of whom were receiving hemodialysis), 66 were from kidney transplant patients, and three were from conservative care patients. The researchers found that the highest average utility was for those who had renal transplantation, 0.82, followed by the pre-dialysis group (0.80), dialysis patients (0.71), and, finally, patients receiving conservative care (0.62). When comparing the type of dialysis, the researchers found that there was little difference in utility between hemodialysis and peritoneal dialysis, but patients using automated peritoneal dialysis had, on average, a higher utility (0.80) than those treated with continuous ambulatory peritoneal dialysis (0.72). Finally, the researchers found that patient groups with diabetes had significantly lower utilities than those without diabetes.
What Do These Findings Mean?
These findings suggest that in people with chronic kidney disease, renal transplantation is the best treatment option to improve quality of life. For those on dialysis, home-based automated peritoneal dialysis may improve quality of life more than the other forms of dialysis: this finding is important, as this type of dialysis is not as widely used as other forms and is also cheaper than hemodialysis. Furthermore, these findings suggest that patients who choose conservative care have significantly lower quality of life than patients treated with dialysis, a finding that warrants further investigation. Overall, in addition to helping to inform economic evaluations of treatment options, the information from this analysis can help guide clinicians caring for patients with chronic kidney disease in their discussions about possible treatment options.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001307.
Information about chronic kidney disease is available from the National Kidney Foundation and MedlinePlus
Wikipedia gives information on general utilities (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
doi:10.1371/journal.pmed.1001307
PMCID: PMC3439392  PMID: 22984353
3.  Melatonin improves sleep quality in hemodialysis patients 
Indian Journal of Nephrology  2013;23(4):264-269.
Disturbed sleep is common in end-stage renal disease (ESRD). Exogenous melatonin has somniferous properties in normal subjects and can improve sleep quality (SQ) in several clinical conditions. Recent studies have shown that melatonin may play a role in improving sleep in patients undergoing dialysis. The goal of the present study was to assess the effect of exogenous melatonin administration on SQ improvement in daytime hemodialysis patients. Lipid profile and the required dose of erythropoietin (EPO) are also reported as secondary outcomes. In a 6-week randomized, double-blind cross-over clinical trial, 3 mg melatonin or placebo was administered to 68 patients at bedtime. A 72-h washout preceded the switch from melatonin to placebo, or vice versa. SQ was assessed by the Pittsburgh sleep quality index (PSQI). Sixty-eight patients completed the study protocol and were included in the final analysis. Melatonin treatment significantly improved the global PSQI scores (P < 0.001), particularly subjective SQ (P < 0.001), sleep efficiency (P = 0.005) and sleep duration (P < 0.001). No differences in sleep latency and daytime sleepiness were observed. Melatonin also increased the high-density lipoprotein (HDL) cholesterol (P = 0.003). The need for EPO prescription decreased after melatonin treatment (P < 0.001). We conclude that melatonin can improve sleep in ESRD. The modest increase in HDL cholesterol and decrease in the EPO requirement are other benefits associated with this treatment
doi:10.4103/0971-4065.114488
PMCID: PMC3741969  PMID: 23960341
End-stage renal disease; hemodialysis; melatonin; pittsburgh sleep quality index; sleep
4.  Relationship between sleep disturbance and recovery in patients with borderline personality disorder 
Journal of psychosomatic research  2013;74(4):278-282.
Objective
Patients with borderline personality disorder (BPD) frequently experience sleep disturbance, however, the role of sleep quality in the course of BPD is unknown. The purpose of this study was to evaluate the cross-sectional association between sleep quality and recovery status (symptomatic remission plus good concurrent psychosocial functioning) in a well-characterized cohort of patients with BPD to examine the role of sleep disturbance in the course of the disorder.
Methods
223 patients with BPD participating in the McLean Study of Adult Development (MSAD) were administered the Pittsburgh Sleep Quality Index (PSQI) as part of the 16-year follow-up wave. Sleep quality was compared between recovered (n=105) and non-recovered (n=118) BPD participants, including adjustment for age, sex, depression, anxiety, and primary sleep disorders.
Results
Non-recovered BPD patients had significantly worse sleep quality than recovered BPD participants as measured by the global PSQI score (adjusted means 12.01 vs. 10.73, p=0.03). In addition, non-recovered BPD participants had longer sleep onset latency (adjusted means 39.20 vs. 28.11 minutes, p=0.04), as well as increased odds of using sleeping medication (adjusted OR 1.49, p=0.009) and experiencing daytime dysfunction as a result of their sleep disturbance (adjusted OR 1.48, p=0.008).
Conclusion
These results demonstrate an association between subjective sleep disturbance and recovery status among BPD patients. Further research is indicated to evaluate the mechanisms underlying sleep disturbance in BPD, and whether treatment of sleep complaints improves the symptomatic and psychosocial course of the disorder.
doi:10.1016/j.jpsychores.2013.01.006
PMCID: PMC3603271  PMID: 23497827
borderline personality disorder; sleep; insomnia
5.  Sleep Quality in Patients on Maintenance Hemodialysis and Peritoneal Dialysis 
Background:
Sleep disturbances are common among uremic patients; however, limited data are available on predictors of sleep quality in this population. We assessed sleep quality in patients on hemodialysis (HD) and peritoneal dialysis (PD) and investigated predictors related to sleep quality.
Methods:
Patients on maintenance HD and PD were consecutively included from two medical centers in Isfahan city (Iran). They completed the Pittsburgh sleep quality index (PSQI) and hospital anxiety and depression scale. Laboratory tests were done for iron state, kidney function, and electrolytes. Univariate and multivariate analyses were performed to find predictors of sleep quality.
Results:
About 90 patients were evaluated (53 males, age = 54.2 ± 15.2 years, disease duration = 5.3 ± 4.5 years). Poor sleep quality was frequent in 86.6% of the cases in each group of HD and PD patients. Patients on HD had poorer sleep quality in terms of total PSQI scores and two dimensions of sleep latency and sleep efficiency (P < 0.05). Anxiety (β = 0.232, P = 0.027), depression (β = 0.317, P = 0.004), and being on HD (β = 2.095, P = 0.009) were independent predictors of overall poor sleep quality.
Conclusions:
Poor sleep quality is highly frequent in patients on maintenance dialysis and mood disorders and being on HD are predictive factors. Further studies are required for better understanding of risk factors associated with poor sleep quality and thus possible treatments in these patients.
PMCID: PMC3604848  PMID: 23543042
End-stage renal disease; hemodialysis; peritoneal dialysis; risk factors; sleep disorders
6.  Dose–response effects of exercise training on the subjective sleep quality of postmenopausal women: exploratory analyses of a randomised controlled trial 
BMJ Open  2012;2(4):e001044.
Objective
To investigate whether a dose–response relationship existed between exercise and subjective sleep quality in postmenopausal women. This objective represents a post hoc assessment that was not previously considered.
Design
Parallel-group randomised controlled trial.
Setting
Clinical exercise physiology laboratory in Dallas, Texas.
Participants
437 sedentary overweight/obese postmenopausal women.
Intervention
Participants were randomised to one of four treatments, each of 6 months of duration: a non-exercise control treatment (n=92) or one of three dosages of moderate-intensity exercise (50% of VO2peak), designed to meet 50% (n=151), 100% (n=99) or 150% (n=95) of the National Institutes of Health Consensus Development Panel physical activity recommendations. Exercise dosages were structured to elicit energy expenditures of 4, 8 or 12 kilocalories per kilogram of body weight per week (KKW), respectively. Analyses were intent to treat.
Primary outcome measures
Continuous scores and odds of having significant sleep disturbance, as assessed by the Sleep Problems Index from the 6-item Medical Outcomes Study Sleep Scale. Outcome assessors were blinded to participant randomisation assignment.
Results
Change in the Medical Outcomes Study Sleep Problems Index score at 6 months significantly differed by treatment group (control: −2.09 (95% CI −4.58 to 0.40), 4 KKW: −3.93 (−5.87 to −1.99), 8 KKW: −4.06 (−6.45 to −1.67), 12 KKW: −6.22 (−8.68 to −3.77); p=0.04), with a significant dose–response trend observed (p=0.02). Exercise training participants had lower odds of having significant sleep disturbance at postintervention compared with control (4 KKW: OR 0.37 (95% CI 0.19 to 0.73), 8 KKW: 0.36 (0.17 to 0.77), 12 KKW: 0.34 (0.16 to 0.72)). The magnitude of weight loss did not differ between treatment conditions. Improvements in sleep quality were not related to changes in body weight, resting parasympathetic control or cardiorespiratory fitness.
Conclusion
Exercise training induced significant improvement in subjective sleep quality in postmenopausal women, with even a low dose of exercise resulting in greatly reduced odds of having significant sleep disturbance.
Trial registration number
clinicaltrials.gov identifier: NCT00011193.
Article summary
Article focus
Sleep disturbance is prevalent in postmenopausal women, with 35%–60% reporting significant sleep problems.
Effective, safe and easily available treatment options for disturbed sleep in postmenopausal women are lacking.
There has been equivocal evidence as to whether exercise improves sleep in postmenopausal women, though possible dose–response effects have been noted.
Key messages
Exercise resulted in significant improvement in subjective sleep quality in postmenopausal women, with reduced odds of having sleep disturbance at postintervention with even 50% of the recommended dose of exercise for adults.
The effects of exercise on sleep quality were independent of changes in body weight, resting parasympathetic control or cardiorespiratory fitness.
Strengths and limitations of this study
The study constitutes the largest randomised controlled trial on exercise and sleep quality, using a structured dose of exercise and a validated measure of sleep quality.
Only self-reported sleep was assessed; objective measurement of sleep, with either actigraphy or polysomnography, was not conducted.
Despite the high prevalence of sleep disturbance in the sample, participants were not selected on the basis of sleep complaints.
doi:10.1136/bmjopen-2012-001044
PMCID: PMC3400065  PMID: 22798253
7.  Perception versus polysomnographic assessment of sleep in CFS and non-fatigued control subjects: results from a population-based study 
BMC Neurology  2007;7:40.
Background
Complaints of unrefreshing sleep are a prominent component of chronic fatigue syndrome (CFS); yet, polysomnographic studies have not consistently documented sleep abnormalities in CFS patients. We conducted this study to determine whether alterations in objective sleep characteristics are associated with subjective measures of poor sleep quality in persons with CFS.
Methods
We examined the relationship between perceived sleep quality and polysomnographic measures of nighttime and daytime sleep in 35 people with CFS and 40 non-fatigued control subjects, identified from the general population of Wichita, Kansas and defined by empiric criteria. Perceived sleep quality and daytime sleepiness were assessed using clinical sleep questionnaires. Objective sleep characteristics were assessed by nocturnal polysomnography and daytime multiple sleep latency testing.
Results
Participants with CFS reported unrefreshing sleep and problems sleeping during the preceding month significantly more often than did non-fatigued controls. Participants with CFS also rated their quality of sleep during the overnight sleep study as significantly worse than did control subjects. Control subjects reported significantly longer sleep onset latency than latency to fall asleep as measured by PSG and MSLT. There were no significant differences in sleep pathology or architecture between subjects with CFS and control subjects.
Conclusion
People with CFS reported sleep problems significantly more often than control subjects. Yet, when measured these parameters and sleep architecture did not differ between the two subject groups. A unique finding requiring further study is that control, but not CFS subjects, significantly over reported sleep latency suggesting CFS subjects may have an increased appreciation of sleep behaviour that may contribute to their perception of sleep problems.
doi:10.1186/1471-2377-7-40
PMCID: PMC2231384  PMID: 18053240
8.  Insomnia in chronic renal patients on dialysis in Saudi Arabia 
Background
Studies have shown that insomnia is a common sleep disorder among patients with end-stage renal disease (ESRD). This study aimed to assess the prevalence of insomnia in Saudi patients with ESRD who are on maintenance dialysis.
Methods
This was an observational cross-sectional study carried out over a period of five months in two hemodialysis centers in Saudi Arabia. To assess the prevalence of insomnia, we used the ICSD-2 definition. We also examined the association between insomnia and other sleep disorders, the underlying causes of renal failure, dialysis duration, dialysis shift, and other demographic data.
Results
Out of 227 enrolled patients, insomnia was reported by 60.8%. The mean patient age was 55.7 ± 17.2 years; 53.7% were male and 46.3% were female. Insomnia was significantly associated with female gender, afternoon hemodialysis, Restless Legs Syndrome, high risk for obstructive Sleep Apnea Syndrome and excessive daytime sleepiness (P-values: 0.05, 0.01, < 0.0001, < 0.0001, and < 0.0001, respectively). No significant association was found between insomnia and other variables, including BMI, smoking habits, underlying etiology of renal failure, dialysis duration, association with hemoglobin, ferritin, and phosphorus or dialysis adequacy as measured by the Kt/V index.
Conclusion
Insomnia is common in dialysis patients and was significantly associated with other sleep disorders. Greater attention needs to be given to the care of dialysis patients with regard to the diagnosis and management of insomnia and associated sleep disorders.
doi:10.1186/1740-3391-8-7
PMCID: PMC2898657  PMID: 20546577
9.  Design and Rationale of Health-Related Quality of Life and Patient-Reported Outcomes Assessment in the Frequent Hemodialysis Network Trials 
Blood Purification  2011;31(1-3):151-158.
Background
End-stage renal disease patients experience significant impairments in health-related quality of life (HRQOL). Testing various strategies to improve patient HRQOL in multicenter clinical trials, such as the Frequent Hemodialysis Network (FHN) trials is vitally important. Aims: Theaim of this paper is to describe the design and conduct of HRQOL and patient-reported outcomes (PRO) assessment in the FHN trials.
Methods
In the FHN trials, HRQOL was examined as a multidimensional concept, and the SF-36 RAND Physical Health Composite score was one of the co-primary outcomes. The instruments completed to assess HRQOL included the Medical Outcomes Study Short Form SF-36, Health Utilities Index 3, Sleep Problems Index, Beck Depression Inventory and feeling thermometer. These instruments have been shown to have high reliability, validity and responsiveness to change in the end-stage renal disease population. Additional items evaluating PRO including sexual function, time to recovery after dialysis and patients’ self-perceived burden to caregiver were also assessed. All questionnaires were administered by trained interviewers using computer-assisted telephone interviewing to ensure blinding and minimizing selection bias. Interim analysis reveals that these instruments can be used to collect a comprehensive set of HRQOL measures with minimal patient burden.
Conclusions
Accurate measurement of HRQOL and PRO can help us test whether hemodialysis interventions improve the health and well-being of this compromised patient population. We have shown that a comprehensive set of HRQOL measures can be centrally collected through telephone interviews in a blinded fashion, in a way that is well tolerated with minimum respondent burden.
doi:10.1159/000321855
PMCID: PMC3202955  PMID: 21228584
Health-related quality of life; Frequent Hemodialysis Network; End-stage renal disease
10.  Sleep disorders in children 
Clinical Evidence  2007;2007:2304.
Introduction
Sleep disorders may affect 20-30% of young children, and include excessive daytime sleepiness, problems getting to sleep (dysomnias), or undesirable phenomena during sleep (parasomnias), such as sleep terrors, and sleepwalking. Children with physical or learning disabilities are at increased risk of sleep disorders.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of treatments for dysomnias in children? What are the effects of treatments for parasomnias in children? We searched: Medline, Embase, The Cochrane Library and other important databases up to September 2006 (BMJ Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 14 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review we present information relating to the effectiveness and safety of the following interventions: antihistamines, behavioural therapy plus benzodiazepines, or plus chloral and derivates, exercise, extinction and graduated extinction, light therapy, melatonin, safety/protective interventions for parasomnias, scheduled waking (for parasomnias), sleep hygiene, and sleep restriction.
Key Points
Sleep disorders may affect 20-30% of young children, and include excessive daytime sleepiness, problems getting to sleep (dysomnias), or undesirable phenomena during sleep (parasomnias), such as sleep terrors, and sleepwalking. Children with physical or learning disabilities are at increased risk of sleep disorders. Other risk factors include the child being the first born, having a difficult temperament or having had colic, and increased maternal responsiveness.
There is a paucity of evidence about effective treatments for sleep disorders in children, especially parasomnias, but behavioural interventions may be the best first-line approach.
Extinction and graduated extinction interventions improve settling and reduce night wakes compared with placebo in healthy children, and in children with learning disabilities. Graduated extinction may be less distressing for parents, and therefore may have better compliance.Sleep hygiene interventions may reduce bedtime tantrums in healthy children compared with placebo, with similar effectiveness to graduated extinction.Sleep hygiene plus graduated extinction may reduce bedtime tantrums in children with physical or learning disabilities.We don't know whether combining behavioural therapy with benzodiazepines or with chloral improves sleep or parasomnias.
Melatonin may improve sleep onset and sleep time compared with placebo in healthy children, but we don't know if it is beneficial in children with disabilities, if it improves parasomnias, or what its long-term effects might be. We don't know whether antihistamines, exercise, light therapy, or sleep restriction improve dysomnias or parasomnias in children.We don't know whether safety or protective interventions, scheduled waking, extinction, or sleep hygiene are effective in children with parasomnias.
PMCID: PMC2943792  PMID: 19450298
11.  Quality of sleep in dialysis patients 
Background:
Sleep quality is an important and determining factor in the quality of life in dialysis patients. Although many chronic dialysis patients complain of poor sleep, we know little about its related factors. Therefore, this study was designed to study sleep quality and its predictors among dialysis patients.
Materials and Methods:
This was a cross-sectional study carried out during August-December 2009 in Shariati Dialysis Center, Fasa University of Medical Sciences. Data were gathered on 61 patients receiving a hemodialysis treatment. Quality of sleep was measured using the Pittsburgh Sleep Quality Index (PSQI) in dialysis patients in association with the main clinical and biochemical variables. Logistic and multiple linear regressions were used to assess predictors of sleep quality.
Findings:
Forty-five subjects (73.8%) reported poor sleep quality defined as a global PSQI score > 5. As the age (p = 0.036) and duration of dialyses (p = 0.022) increased, sleep quality decreased. Significant differences were found between sex and sleep quality (p = 0.044). Sleep quality problems had a significant association with MCV (p = 0.025).
Conclusions:
Poor sleep quality is a very common problem in dialysis patients. Assessment and management of sleep quality should be an important component of care giving to these patients. Large prospective longitudinal studies are needed to confirm the high prevalence of impaired quality of sleep and its related factors while controlling confounding variables.
PMCID: PMC3702145  PMID: 23833625
Hemodialysis; sleep quality; Pittsburgh sleep quality index (PSQI) questionnaire; MCV; CBC
12.  A pilot evaluation of an online cognitive behavioral therapy for insomnia disorder – targeted screening and interactive Web design lead to improved sleep in a community population 
Introduction
Computerized or online cognitive behavioral therapies (CBTs) are increasingly being developed to deliver insomnia therapy (CBT-i). They seek to address the difficulty of delivering an evidence-based technology to a large number of patients at low cost. Previous online applications have shown significant but variable improvements in sleep efficiency and a decrease in insomnia severity when compared with control groups. The best online methodology remains debated, and there are no such applications currently available within the UK National Health Service.
Method
Evaluation of treatment outcomes in 75 participants with insomnia disorder using an open-access, novel, interactive online therapy. Rigorous screening was first undertaken to exclude those with probable sleep apnea, restless legs, circadian rhythm disorder, or significant anxiety or depression prior to commencing therapy. A modern interactive video-based website was used to encourage compliance by personalizing therapy based on response. Sleep efficiency, sleep latency, total sleep time, and sleep quality were all assessed prior to and after intervention.
Results
Of those who accessed therapy, 62% were excluded based on a likely diagnosis of another sleep disorder (788/1281). Participants who completed therapy all had severe insomnia disorder, with a group mean sleep efficiency of 55%. After intervention there was a significant increase in sleep efficiency and sleep latency, with modest nonsignificant improvements in total sleep time. The majority of users reported improved sleep quality, and compliance with therapy was very good, with over 64/75 completing >90% of sleep diary entries.
Conclusion
Online CBT-i can be designed to deliver personalized therapy with good reported outcomes and high compliance rates in those who start therapy. This initial evaluation also suggests that screening for other sleep disorders and mental health problems is necessary as many other sleep disorders are detected in those who self-refer with insomnia. This would inform the development of any larger-scale applications within the psychological therapies used in the health care system.
doi:10.2147/NSS.S57852
PMCID: PMC3962311  PMID: 24669197
CBT; online applications; sleep efficiency; sleep latency; total sleep time; sleep quality; compliance
13.  Sleep disorders in children 
Clinical Evidence  2010;2010:2304.
Introduction
Sleep disorders may affect between 20% and 30% of young children, and include problems getting to sleep (dyssomnias), or undesirable phenomena during sleep (parasomnias), such as sleep terrors and sleepwalking. Children with physical or learning disabilities are at increased risk of sleep disorders.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of treatments for dyssomnias in children? What are the effects of treatments for parasomnias in children? We searched: Medline, Embase, The Cochrane Library, and other important databases up to September 2009 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 28 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review we present information relating to the effectiveness and safety of the following interventions: antihistamines; behavioural therapy plus antihistamines, plus benzodiazepines, or plus chloral and derivatives; benzodiazepines alone; exercise; extinction and graduated extinction; 5-hydroxytryptophan; light therapy; melatonin; safety/protective interventions for parasomnias; scheduled waking (for parasomnias); sleep hygiene; and sleep restriction.
Key Points
Sleep disorders may affect between 20% and 30% of young children, and include problems getting to sleep (dyssomnias) or undesirable phenomena during sleep (parasomnias), such as sleep terrors and sleepwalking. Children with physical or learning disabilities are at increased risk of sleep disorders. Other risk factors include the child being the first born, having a difficult temperament or having had colic, and increased maternal responsiveness.
There is a paucity of evidence about effective treatments for sleep disorders in children, especially parasomnias, but behavioural interventions may be the best first-line approach.
Extinction and graduated extinction in otherwise healthy children with dyssomnia may improve sleep quality and settling, and reduce the number of tantrums and wakenings compared with no treatment. Extinction and graduated extinction in children with physical disabilities, learning disabilities, epilepsy, or attention-deficit disorder with dyssomnia may be more effective at improving settling, reducing the frequency and duration of night wakings, and improving parental sleep compared with no treatment; however, we don't know whether it is more effective in improving sleep duration.Graduated extinction may be less distressing for parents, and therefore may have better compliance.
Sleep hygiene for dyssomnia in otherwise healthy children may be more effective in reducing the number and duration of bedtime tantrums compared with placebo, but we don’t know if it is more effective at reducing night wakenings, improving sleep latency, improving total sleep duration, or improving maternal mood. Sleep hygiene and graduated extinction seem to be equally effective at reducing bedtime tantrums in otherwise healthy children with dyssomnia.We don't know whether sleep hygiene for dyssomnia in children with physical disabilities, learning disabilities, epilepsy, or attention-deficit disorder is effective.
Melatonin for dyssomnia in otherwise healthy children may be more effective at improving sleep-onset time, total sleep time, and general health compared with placebo. Evidence of improvements in dyssomnia with melatonin is slightly stronger in children with physical disabilities, learning disabilities, epilepsy, or attention-deficit disorder.
Little is known about the long-term effects of melatonin, and the quality of the product purchased could be variable as melatonin is classified as a food supplement.
Antihistamines for dyssomnia may be more effective than placebo at reducing night wakenings and decreasing sleep latency, but we don’t know if they are more effective at increasing sleep duration. The evidence for antihistamines in dyssomnia comes from only one small, short-term study.
We don’t know whether behavioural therapy plus antihistamines, plus benzodiazepines, or plus chloral and derivatives, exercise, light therapy, or sleep restriction are effective in children with dyssomnia.
We don’t know whether antihistamines, behavioural therapy plus benzodiazepines or plus chloral and derivatives, benzodiazepines, 5-hydroxytryptophan, melatonin, safety/protective interventions, scheduled waking, sleep hygiene, or sleep restriction are effective in children with parasomnia.
PMCID: PMC3217667  PMID: 21418676
14.  Assessing Sleep in Opioid Dependence: A Comparison of Subjective Ratings, Sleep Diaries, and Home Polysomnography in Methadone Maintenance Patients 
Drug and alcohol dependence  2010;113(2-3):245-248.
Objectives
Comparisons of subjective and objective sleep measures have shown discrepancies between reported sleep and polysomnography (PSG) in non-drug dependent individuals with and without insomnia. Sleep may affect behavioral and physiologic aspects of drug abuse and dependence; patients in methadone maintenance therapy (MMT) for opioid dependence frequently report sleep problems. Whether subjective sleep reflects objective sleep in MMT patients is unknown. We undertook these analyses to establish the correlations among subjective and objective sleep measures in MMT patients.
Methods
We compared one week of daily sleep diaries, one night of home PSG, a questionnaire completed the morning after PSG, and the Pittsburgh Sleep Quality Inventory (PSQI) as well as demographics and drug use measures in 62 MMT patients with disturbed sleep (PSQI score > 5).
Results
Subjective and objective sleep durations were similar in this sample; average sleep times for the diary, morning questionnaire, and PSG were 340, 323, and 332 minutes, respectively. Average diary sleep time, subjective ratings of feeling rested, and PSG sleep efficiency were correlated significantly with PSQI score. Age was inversely correlated with PSG sleep time. Participants whose urine toxicology showed benzodiazapine use reported significantly longer sleep times on the morning questionnaire.
Conclusions
Objective sleep measures confirm subjective measures in MMT patients with disturbed sleep. The high prevalence of sleep complaints in this population likely reflects pathology rather than sleep misperception. Both objective and subjective measures are useful in research and clinical settings for assessing sleep in opioid-dependent patients.
doi:10.1016/j.drugalcdep.2010.08.007
PMCID: PMC3025068  PMID: 20850231
methadone; opioid dependence; sleep; polysomnography; PSQI; sleep diaries
15.  Obstructive Sleep Apnea and Risk of Cardiovascular Events and All-Cause Mortality: A Decade-Long Historical Cohort Study 
PLoS Medicine  2014;11(2):e1001599.
Tetyana Kendzerska and colleagues explore the association between physiological measures of obstructive sleep apnea other than the apnea-hypopnea index and the risk of cardiovascular events.
Please see later in the article for the Editors' Summary
Background
Obstructive sleep apnea (OSA) has been reported to be a risk factor for cardiovascular (CV) disease. Although the apnea-hypopnea index (AHI) is the most commonly used measure of OSA, other less well studied OSA-related variables may be more pathophysiologically relevant and offer better prediction. The objective of this study was to evaluate the relationship between OSA-related variables and risk of CV events.
Methods and Findings
A historical cohort study was conducted using clinical database and health administrative data. Adults referred for suspected OSA who underwent diagnostic polysomnography at the sleep laboratory at St Michael's Hospital (Toronto, Canada) between 1994 and 2010 were followed through provincial health administrative data (Ontario, Canada) until May 2011 to examine the occurrence of a composite outcome (myocardial infarction, stroke, congestive heart failure, revascularization procedures, or death from any cause). Cox regression models were used to investigate the association between baseline OSA-related variables and composite outcome controlling for traditional risk factors. The results were expressed as hazard ratios (HRs) and 95% CIs; for continuous variables, HRs compare the 75th and 25th percentiles. Over a median follow-up of 68 months, 1,172 (11.5%) of 10,149 participants experienced our composite outcome. In a fully adjusted model, other than AHI OSA-related variables were significant independent predictors: time spent with oxygen saturation <90% (9 minutes versus 0; HR = 1.50, 95% CI 1.25–1.79), sleep time (4.9 versus 6.4 hours; HR = 1.20, 95% CI 1.12–1.27), awakenings (35 versus 18; HR = 1.06, 95% CI 1.02–1.10), periodic leg movements (13 versus 0/hour; HR = 1.05, 95% CI 1.03–1.07), heart rate (70 versus 56 beats per minute [bpm]; HR = 1.28, 95% CI 1.19–1.37), and daytime sleepiness (HR = 1.13, 95% CI 1.01–1.28).The main study limitation was lack of information about continuous positive airway pressure (CPAP) adherence.
Conclusion
OSA-related factors other than AHI were shown as important predictors of composite CV outcome and should be considered in future studies and clinical practice.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Obstructive sleep apnea (OSA) is a common sleep-related breathing disorder, particularly among middle-aged and elderly people. It is characterized by apnea—a brief interruption in breathing that lasts at least 10 seconds—and hypopnea—a decrease of more than 50% in the amplitude of breathing that lasts at least 10 seconds or clear but smaller decrease in amplitude associated with either oxygen desaturation or an arousal. Patients with OSA experience numerous episodes of apnea and hypopnea during the night; severe OSA is defined as having 30 or more episodes per hour (an apnea-hypopnea index [AHI] of >30). These breathing interruptions occur when relaxation of the upper airway muscles decreases the airflow, which lowers the amount of oxygen in the blood. As a result, affected individuals frequently wake from deep sleep as they struggle to breathe. Symptoms of OSA include loud snoring and daytime sleepiness. Treatments include lifestyle changes such as losing weight (excess fat around the neck increases airway collapse) and smoking cessation. For severe OSA, doctors recommend continuous positive airway pressure (CPAP), in which a machine blows pressurized air through a face mask into the airway to keep it open.
Why Was This Study Done?
OSA can be life-threatening. Most directly, daytime sleepiness can cause accidents, but OSA is also associated with an increased risk of developing cardiovascular disease (CVD, disease that affects the heart and the circulation). To date, studies that have investigated the association between OSA and the risk of myocardial infarction (heart attack), congestive heart failure, stroke, and other CVDs have used the AHI to diagnose and categorize the severity of OSA. However, by focussing on AHI, clinicians and researchers may be missing opportunities to improve their ability to predict which patients are at the highest risk of CVD. In this historical cohort study, the researchers investigate the association between other OSA-related variables (for example, blood oxygen saturation and sleep fragmentation) and the risk of cardiovascular events and all-cause mortality (death). A historical cohort study examines the medical records of groups of individuals who have different characteristics at baseline for the subsequent occurrence of specific outcomes.
What Did the Researchers Do and Find?
The researchers used administrative data (including hospitalization records and physicians' claims for services supplied to patients) to follow up adults referred for suspected OSA who underwent diagnostic polysomnography (a sleep study) at a single Canadian hospital between 1994 and 2010. A database of the polysomnography results provided information on OSA-related variables for all the study participants. Over an average follow-up of about 6 years, 11.5% of the 10,149 participants were hospitalized for a myocardial infarction, stroke, or congestive heart failure, underwent a revascularization procedure (an intervention that restores the blood supply to an organ or tissue after CVD has blocked a blood vessel), or had died from any cause. After adjusting for multiple established risk factors for CVD such as smoking and age in Cox regression models (a statistical approach that examines associations between patient variables and outcomes), several OSA-related variables (but not AHI) were significant predictors of CVD. The strongest OSA-related predictor of cardiovascular events or all-cause mortality was total sleep time spent with oxygen saturation below 90%, which increased the risk of a cardiovascular event or death by 50%. Other statistically significant OSA-related predictors (predictors that were unlikely to be associated with the outcome through chance) of cardiovascular events or death included total sleep time, number of awakenings, frequency of periodic leg movements, heart rate, and daytime sleepiness.
What Do These Findings Mean?
These findings indicate that OSA-related factors other than AHI are important predictors of the composite outcome of a cardiovascular event or all-cause mortality. Indeed, although AHI was significantly associated with the researchers' composite outcome in an analysis that did not consider other established risk factors for CVD (“confounders”), the association became non-significant after controlling for potential confounders. The accuracy of these findings, which need to be confirmed in other settings, is likely to be limited by the lack of information available about the use of CPAP by study participants and by the lack of adjustment for some important confounders. Importantly, however, these findings suggest that OSA-related factors other than AHI should be considered as predictors of CVD in future studies and in clinical practice.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001599.
The US National Heart Lung and Blood Institute has information (including several videos) about obstructive sleep apnea (in English and Spanish), sleep studies, heart disease, and other cardiovascular diseases (some information in English and Spanish)
The UK National Health Service Choices website provides information (including personal stories) about sleep apnea and about cardiovascular disease
The not-for-profit American Sleep Apnea Association provides detailed information about sleep apnea for patients and health-care professionals, including personal stories about the condition
The MedlinePlus encyclopedia has pages on obstructive sleep apnea and on polysomnography; MedlinePlus provides links to further information and advice about obstructive sleep apnea, heart diseases, and vascular diseases (in English and Spanish)
doi:10.1371/journal.pmed.1001599
PMCID: PMC3913558  PMID: 24503600
16.  Investigating efficacy of two brief mind–body intervention programs for managing sleep disturbance in cancer survivors: a pilot randomized controlled trial 
Journal of Cancer Survivorship  2013;7(2):165-182.
Purpose
After completing treatment, cancer survivors may suffer from a multitude of physical and mental health impairments, resulting in compromised quality of life. This exploratory study investigated whether two mind–body interventions, i.e., Mind–Body Bridging (MBB) and Mindfulness Meditation (MM), could improve posttreatment cancer survivors’ self-reported sleep disturbance and comorbid symptoms, as compared to sleep hygiene education (SHE) as an active control.
Methods
This randomized controlled trial examined 57 cancer survivors with clinically significant self-reported sleep disturbance, randomly assigned to receive MBB, MM, or SHE. All interventions were conducted in three sessions, once per week. Patient-reported outcomes were assessed via the Medical Outcomes Study Sleep Scale and other indicators of psychosocial functioning relevant to quality of life, stress, depression, mindfulness, self-compassion, and well-being.
Results
Mixed effects model analysis revealed that mean sleep disturbance symptoms in the MBB (p = .0029) and MM (p = .0499) groups were lower than in the SHE group, indicating that both mind–body interventions improved sleep. In addition, compared with the SHE group, the MBB group showed reductions in self-reported depression symptoms (p = .040) and improvements in overall levels of mindfulness (p = .018), self-compassion (p = .028), and well-being (p = .019) at postintervention.
Conclusions
This study provides preliminary evidence that brief sleep-focused MBB and MM are promising interventions for sleep disturbance in cancer survivors. Integrating MBB or MM into posttreatment supportive plans should enhance care of cancer survivors with sleep disturbance. Because MBB produced additional secondary benefits, MBB may serve as a promising multipurpose intervention for posttreatment cancer survivors suffering from sleep disturbance and other comorbid symptoms.
Implications for Cancer Survivors
Two brief sleep-focused mind–body interventions investigated in the study were effective in reducing sleep disturbance and one of them further improved other psychosocial aspects of the cancer survivors’ life. Management of sleep problems in survivors is a high priority issue that demands more attention in cancer survivorship.
doi:10.1007/s11764-012-0252-8
PMCID: PMC3622018  PMID: 23338490
Mind–body bridging; Mindfulness meditation; Cancer survivors; Sleep disturbance; Depression; Quality of life
17.  Impact of paroxetine on sleep problems in 426 cancer patients receiving chemotherapy: A trial from the University of Rochester Cancer Center Community Clinical Oncology Program 
Sleep medicine  2012;13(9):1184-1190.
Background
Sleep problems are a frequent distressing symptom in cancer patients, yet little is known about their treatment. Sleep problems and depression frequently co-occur, leading healthcare professionals to treat depression with the expectation that sleep problems will also improve. The purpose of this study was to compare the effect of paroxetine to placebo on sleep problems via a secondary data analysis of a RCT designed to compare the effects of paroxetine to placebo on fatigue in cancer patients undergoing chemotherapy. A previously published report found a significant effect of paroxetine on depression in this cohort.
Methods
A total of 426 patients were randomized following Cycle 2 of chemotherapy to receive either 20 mg of paroxetine or placebo. Sleep problems were assessed using questions from the Hamilton Depression Inventory three times during chemotherapy.
Results
A total of 217 patients received paroxetine and 209 received placebo. Significantly fewer patients taking paroxetine reported sleep problems compared to patients on placebo (Paroxetine 79% versus Placebo 88%; p < 0.05). These differences remained significant even after controlling for baseline sleep problems and depression (p < 0.05).
Conclusion
Paroxetine had a significant benefit on sleep problems in both depressed and non-depressed cancer patients. However, rates of sleep problems remained high even among those effectively treated for depression with paroxetine. There is a need to develop and deliver sleep-specific interventions to effectively treat sleep-related side effects of cancer treatments. These findings suggest that sleep problems and depression are prevalent and co-morbid. Cancer progression, its response to treatment, and overall patient survival are intricately linked to host factors, such as inflammatory response and circadian rhythms, including sleep/wake cycles. Sleep problems and depression are modifiable host factors that can influence inflammation and impact cancer progression and quality of life. Future research should focus on discovering the pathogenesis of sleep dysregulation and depression in cancer so that better treatment approaches can be developed to ameliorate these symptoms.
doi:10.1016/j.sleep.2012.06.001
PMCID: PMC3664933  PMID: 22858235
18.  Randomised controlled trial of behavioural infant sleep intervention to improve infant sleep and maternal mood 
BMJ : British Medical Journal  2002;324(7345):1062.
Objective
To compare the effect of a behavioural sleep intervention with written information about normal sleep on infant sleep problems and maternal depression.
Design
Randomised controlled trial.
Setting
Well child clinics, Melbourne, Australia
Participants
156 mothers of infants aged 6-12 months with severe sleep problems according to the parents.
Main outcome measures
Maternal report of infant sleep problem; scores on Edinburgh postnatal depression scale at two and four months.
Intervention
Discussion on behavioural infant sleep intervention (controlled crying) delivered over three consultations.
Results
At two months more sleep problems had resolved in the intervention group than in the control group (53/76 v 36/76, P=0.005). Overall depression scores fell further in the intervention group than in the control group (mean change −3.7, 95% confidence interval −4.7 to −2.7, v −2.5, −1.7 to −3.4, P=0.06). For the subgroup of mothers with depression scores of 10 and over more sleep problems had resolved in the intervention group than in the control group (26/33 v 13/33, P=0.001). In this subgroup depression scores also fell further for intervention mothers than control mothers at two months (−6.0, −7.5 to −4.0, v −3.7, −4.9 to −2.6, P=0.01) and at four months (−6.5, −7.9 to 5.1 v –4.2, –5.9 to −2.5, P=0.04). By four months, changes in sleep problems and depression scores were similar.
Conclusions
Behavioural intervention significantly reduces infant sleep problems at two but not four months. Maternal report of symptoms of depression decreased significantly at two months, and this was sustained at four months for mothers with high depression scores.
What is already known on this topicInfant sleep problems and postnatal depression are both common potentially serious problemsWomen whose infants have sleep problems are more likely to report symptoms of depressionUncontrolled studies in clinical populations suggest that reducing infant sleep problems improves postnatal depression, but there is no good quality evidence in the community for such effectivenessWhat this study addsA brief community based sleep intervention based on teaching the controlled crying method effectively decreased infant sleep problems and symptoms of maternal depression, particularly for “depressed” mothersThe intervention was acceptable to mothers and reduced the need for other sources of help
PMCID: PMC104332  PMID: 11991909
19.  Sleep education during pregnancy for new mothers 
Background
There is a high association between disturbed (poor quality) sleep and depression, which has lead to a consensus that there is a bidirectional relationship between sleep and mood. One time in a woman’s life when sleep is commonly disturbed is during pregnancy and following childbirth. It has been suggested that sleep disturbance is another factor that may contribute to the propensity for women to become depressed in the postpartum period compared to other periods in their life. Post Natal Depression (PND) is common (15.5%) and associated with sleep disturbance, however, no studies have attempted to provide a sleep-focused intervention to pregnant women and assess whether this can improve sleep, and consequently maternal mood post-partum. The primary aim of this research is to determine the efficacy of a brief psychoeducational sleep intervention compared with a control group to improve sleep management, with a view to reduce depressive symptoms in first time mothers.
Method
This randomised controlled trial will recruit 214 first time mothers during the last trimester of their pregnancy. Participants will be randomised to receive either a set of booklets (control group) or a 3hour psychoeducational intervention that focuses on sleep. The primary outcomes of this study are sleep-related, that is sleep quality and sleepiness for ten months following the birth of the baby. The secondary outcome is depressive symptoms. It is hypothesised that participants in the intervention group will have better sleep quality and sleepiness in the postpartum period than women in the control condition. Further, we predict that women who receive the sleep intervention will have lower depression scores postpartum compared with the control group.
Discussion
This study aims to provide an intervention that will improve maternal sleep in the postpartum period. If sleep can be effectively improved through a brief psychoeducational program, then it may have a protective role in reducing maternal postpartum depressive symptoms.
Registration details
This trial is registered with the Australian New Zealand Clinical Trials Register under the registration number ACTRN12611000859987
doi:10.1186/1471-2393-12-155
PMCID: PMC3546917  PMID: 23244163
Sleep; New mothers; Postnatal; Postpartum; Depression; Psychoeducation
20.  The impact on sleep of a multidisciplinary cognitive behavioural pain management programme: a pilot study 
Background
Reduced sleep quality is a common complaint among patients with chronic pain, with 50-80% of patients reporting sleep disturbance. Improvements in pain and quality of life measures have been achieved using a multidisciplinary cognitive behavioural therapy pain management programme (CBT-PMP) that aims to recondition attitudes to pain, and improve patients' self-management of their condition. Despite its high prevalence in patients with chronic pain, there is very limited objective evidence for the effect of this intervention on sleep quality. The primary research objective is to investigate the short-term effect of a multidisciplinary CBT-PMP on subjective (measured by Pittsburg Sleep Quality Index) and objective sleep quality (measured by Actigraphy) in patients with chronic pain by comparison with a control group. The secondary objectives will investigate changes in function and mood, and then explore the relationship between objective and subjective sleep quality and physical and psychological outcome measures.
Methods/Design
Patients who fulfil the inclusion criteria for attendance on the multidisciplinary CBT-PMP in the Adelaide and Meath Hospital, Tallaght, Dublin and are currently listed on the PMP waiting list will be invited to participate in this pilot study. Potential patients will be screened for sleep disturbance [determined by the Pittsburgh Sleep Quality Index (PSQI)]. Those patients with a sleep disturbance (PSQI >5) will be assigned to either the intervention group (immediate treatment), or control group (deferred treatment, i.e. the PMP they are listed for is more than six months away) based on where they appear on the waiting list. Baseline measures of sleep, function, and mood will be obtained using a combination of self-report questionnaires (the Hospital Anxiety and Depression Scale, the Short Form 36 health survey, the Pittsburgh Sleep Quality Index, the Tampa Scale for Kinesiophobia), and functional outcome measures. Sleep will be measured for seven days using actigraphy (Actiwatch 7). These measures will be repeated after the four week multidisciplinary cognitive behavioural therapy pain management programme, and at a two month follow-up. The waiting list control group will be assessed at baseline, and two months later. Analysis for the primary outcome will include between group differences of subjective and objective sleep parameters from baseline to follow-up using Independent T-tests or Mann-Whitney U tests. The secondary outcomes establishing relationships between the sleep variables and physical and psychological outcome measures will be established using multiple linear regression models.
Discussion
This pilot study will evaluate the impact of a multidisciplinary CBT-PMP on both subjective and objective measures of sleep in patients with chronic pain and provide guidance for a larger clinical trial.
Trial Registration
Current controlled trial ISRCTN: ISRCTN74913595
doi:10.1186/1471-2474-12-5
PMCID: PMC3024274  PMID: 21219600
21.  Resistant Hypertension and Obstructive Sleep Apnea in the Setting of Kidney Disease 
Journal of hypertension  2012;30(5):960-966.
Objectives
To explore the relationship between obstructive sleep apnea (OSA) and resistant hypertension in chronic kidney disease (CKD) and end-stage renal disease (ESRD).
Methods
We examined sleep parameters and blood pressure (BP) in 224 community-based, non-CKD participants from the Sleep-SCORE study, 88 non-dialysis dependent CKD and 95 ESRD participants. Unattended home polysomnography with standardized scoring protocols and automated BP monitors were used. Resistant hypertension was defined as a BP ≥ 140/90 mmHg despite ≥ 3 antihypertensives.
Results
Mean systolic BP of the CKD and ESRD groups were significantly higher than the non-CKD group (148.2mmHg [23.8], 144.5mmHg [26.7] vs. 132.2mmHg [26.7], respectively; P<0.0001) despite the use of more anti-hypertensive medications. The CKD and ESRD groups had higher rates of resistant hypertension than the non-CKD group (41.4%, 22.6% vs. 6.7%, respectively; P<0.0001). The severity of sleep apnea was associated with a higher risk of resistant hypertension. While resistant hypertension was associated with severe sleep apnea in participants with ESRD (odds ratio [OR] 7.1, 95% confidence interval [CI] 2.2-23.2), there was no significant association in the non-CKD (OR 3.5, 95% CI 0.8-15.4) or CKD groups (OR 1.2, 95% CI 0.4-3.7) after accounting for case-mix.
Conclusion
The association between resistant hypertension and sleep apnea appeared robust in ESRD. OSA may contribute to resistant hypertension or both may be linked to a common underlying process such as volume excess. Future studies in patients with kidney disease should further characterize the resistant hypertension - OSA relationship and determine whether treatment of underlying mechanisms may improve outcomes.
doi:10.1097/HJH.0b013e328351d08a
PMCID: PMC3771863  PMID: 22388231
Sleep apnea; chronic kidney disease; end-stage renal disease; hypertension; resistant hypertension
22.  Sleep architecture in ziprasidone-treated bipolar depression: a pilot study 
Objectives:
This study investigated the effect of ziprasidone augmentation therapy on sleep architecture in bipolar depression.
Methods:
We conducted a double-blind, randomized, placebo-controlled clinical pilot trial of ziprasidone versus placebo in Diagnostic and Statistical Manual of Mental Disorders, fourth edition bipolar disorder with current major depressive episode. The effects during acute (2–5 days) and continuation treatment (28–31 days) were measured. Main outcomes were sleep architecture variables including rapid eye movement sleep (REM) and slow wave sleep (SWS) measured by polysomnography. Secondary outcomes included subjective sleep quality measures and illness severity measures including the 17-item Hamilton Depression Rating Scale (HAMD-17), Montgomery Asberg Depression Rating Scale (MADRS), Hamilton Anxiety Rating Scale (HAMA) and Clinical Global Illness Severity (CGI-S) scores.
Results:
The completer analysis comprised of 14 patients (ziprasidone, N = 8 and placebo, N = 6). Latency to REM, duration of SWS, duration of stage 2 sleep, total sleep time, onset to sleep latency, number of awakenings and overall sleep efficiency significantly improved in ziprasidone-treated participants over placebo. CGI-S and HAMA scores also significantly improved. No significant difference between treatment groups was seen on the HAMD-17, MADRS or in self-reported sleep quality. Increase in SWS duration significantly correlated with improvement in CGI-S, however, this finding did not withstand Bonferroni correction.
Conclusion:
Adjunctive ziprasidone treatment alters sleep architecture in patients with bipolar depression, which may partially explain its mechanism of action and merits further investigation.
doi:10.1177/2045125312467348
PMCID: PMC3805453  PMID: 24167686
Atypical antipsychotic; bipolar depression; polysomnography; sleep architecture; ziprasidone; REM; SWS
23.  Nocturnal sleep, daytime sleepiness, and quality of life in stable patients on hemodialysis 
Background
Although considerable progress has been made in the treatment of chronic kidney disease, compromised quality of life continues to be a significant problem for patients receiving hemodialysis (HD). However, in spite of the high prevalence of sleep complaints and disorders in this population, the relationship between these problems and quality of life remains to be well characterized. Thus, we studied a sample of stable HD patients to explore relationships between quality of life and both subjective and objective measures of nocturnal sleep and daytime sleepiness
Methods
The sample included forty-six HD patients, 24 men and 22 women, with a mean age of 51.6 (10.8) years. Subjects underwent one night of polysomnography followed the next morning by a Multiple Sleep Latency Test (MSLT), an objective measure of daytime sleepiness. Subjects also completed: 1) a brief nocturnal sleep questionnaire; 2) the Epworth Sleepiness Scale; and, 3) the Quality of Life Index (QLI, Dialysis Version) which provides an overall QLI score and four subscale scores for Health & Functioning (H&F), Social & Economic (S&E), Psychological & Spiritual (P&S), and Family (F). (The range of scores is 0 to 30 with higher scores indicating better quality of life.)
Results
The mean (standard deviation; SD) of the overall QLI was 22.8 (4.0). The mean (SD) of the four subscales were as follows: H&F – 21.1 (4.7); S&E – 22.0 (4.8); P&S – 24.5 (4.4); and, F – 26.8 (3.5). H&F (rs = -0.326, p = 0.013) and F (rs = -0.248, p = 0.048) subscale scores were negatively correlated with periodic limb movement index but not other polysomnographic measures. The H&F subscale score were positively correlated with nocturnal sleep latency (rs = 0.248, p = 0.048) while the H&F (rs = 0.278, p = 0.030) and total QLI (rs = 0.263, p = 0.038) scores were positively associated with MSLT scores. Both of these latter findings indicate that higher life quality is associated with lower sleepiness levels. ESS scores were unrelated to overall QLI scores or the subscale scores. Subjective reports of difficulty falling asleep and waking up too early were significantly correlated with all four subscale scores and overall QLI. Feeling rested in the morning was positively associated with S&E, P&S, and Total QLI scores.
Conclusion
Selected measures of both poor nocturnal sleep and increased daytime sleepiness are associated with decreased quality of life in HD patients, underscoring the importance of recognizing and treating these patients' sleep problems.
doi:10.1186/1477-7525-1-68
PMCID: PMC320494  PMID: 14633280
24.  Age-related differences in the quality of life in end-stage renal disease in patients enrolled in hemodialysis or continuous peritoneal dialysis 
Background
The aim of the present study was to compare the experience elderly and younger patients in terms of emotional status, disease perception, methods of coping with the end-stage renal disease (ESRD) stress, and health-related quality of life in 2 different settings of renal replacement therapy: hemodialysis (HD) and continuous ambulatory peritoneal dialysis programs (CAPD). Specifically, we hypothesized that younger people will more frequently use goal-oriented strategies to cope with illness-related stress and elderly patients will use more strategies related to the control of emotion.
Material/Methods
A total of 69 HD patients, 40 CAPD patients, and 89 healthy volunteers were analyzed. The Situation and Trait Anxiety Inventory, the Profile of Mood States, the Cognitive Stress Appraisal Questionnaire, and the Nottingham Health Profile were used to assess anxiety, long-term emotional status, coping mechanisms, and health-related quality of life. Data were collected on several biochemical and demographic variables.
Results
Our study revealed that younger and elderly people on dialysis faced quite different problems. Younger people in both RRT groups had statistically higher assessment of ESRD as loss or challenge and they more frequently used distractive and emotional preoccupation coping strategies. Depression, confusion, and bewilderment dominate the emotional status of both patient populations, especially in the younger cohort. Both HDyoung and CAPDyoung patients complained more about lack of energy, mobility limitations, and sleep disturbances as compared to their elderly HD and CAPD counterparts.
Conclusions
There are different needs and problems in younger and elderly patients on renal replacement therapy. Younger people required more ESRD-oriented support to relieve their health-related complaints to the level observed in their peers and needed extensive psychological assistance in order to cope with negative emotions related to their disease.
doi:10.12659/MSM.883916
PMCID: PMC3665666  PMID: 23685340
age; continuous peritoneal dialysis; health-related quality of life; coping; hemodialysis
25.  Aerobic exercise improves self-reported sleep and quality of life in older adults with insomnia 
Sleep medicine  2010;11(9):934-940.
Objective
To assess the efficacy of moderate aerobic physical activity with sleep hygiene education to improve sleep, mood and quality of life in older adults with chronic insomnia.
Methods
Seventeen sedentary adults aged ≥55 years with insomnia (mean age 61.6 (SD±4.3) years; 16 female) participated in a randomized controlled trial comparing 16 weeks of aerobic physical activity plus sleep hygiene to non-physical activity plus sleep hygiene. Eligibility included primary insomnia for at least 3 months, habitual sleep duration < 6.5 hours and a Pittsburgh Sleep Quality Index (PSQI) score > 5. Outcomes included sleep quality, mood and quality of life questionnaires (PSQI, Epworth Sleepiness Scale [ESS], Short-form 36 [SF-36], Center for Epidemiological Studies Depression Scale [CES-D]).
Results
The physical activity group improved in sleep quality on the global PSQI (p<0.0001), sleep latency (p=0.049), sleep duration (p=0.04), daytime dysfunction (p=0.027), and sleep efficiency (p=0.036) PSQI sub-scores compared to the control group. The physical activity group also had reductions in depressive symptoms (p=0.044), daytime sleepiness (p=0.02) and improvements in vitality (p=0.017) compared to baseline scores.
Conclusion
Aerobic physical activity with sleep hygiene education is an effective treatment approach to improve sleep quality, mood and quality of life in older adults with chronic insomnia.
doi:10.1016/j.sleep.2010.04.014
PMCID: PMC2992829  PMID: 20813580
Sleep; physical activity; quality of life; depression; insomnia

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