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1.  Diurnal variation of tension-type headache intensity and exacerbation: An investigation using computerized ecological momentary assessment 
Backgrounds
Tension-type headache is a common psychosomatic disease. However, diurnal variation of headache is yet to be clarified, perhaps due to the lack of an appropriate method to investigate it. Like other painful diseases, it would be helpful to know if there is diurnal variation in tension-type headaches, both for managing headaches and understanding their pathophysiology. The aim of this study was to determine if there is diurnal variation in the intensity and exacerbation of tension-type headache.
Methods
Patients (N = 31) with tension-type headache recorded for one week their momentary headache intensity several times a day and their acute headache exacerbations using a watch-type computer as an electronic diary (computerized ecological momentary assessment). Multilevel modeling was used to test the effects of time of day on momentary headache intensity and on the occurrence of acute exacerbations.
Results
A significant diurnal variation in momentary headache intensity was shown (P = 0.0005), with the weakest headaches in the morning and a peak in the late afternoon. A between-individual difference in the diurnal pattern was suggested. On-demand medication use was associated with a different diurnal pattern (P = 0.025), suggesting that headache intensity decreases earlier in the evening in subjects who used on-demand medication, while headache subtype, prophylactic medication use, and sex were not associated with the difference. The occurrence of acute headache exacerbation also showed a significant diurnal variation, with a peak after noon (P = 0.0015).
Conclusions
Tension-type headache was shown to have a significant diurnal variation. The relation to pathophysiology and psychosocial aspects needs to be further explored.
doi:10.1186/1751-0759-6-18
PMCID: PMC3479012  PMID: 22943264
Tension-type headache; Ecological momentary assessment; Electronic diary; Diurnal variation
2.  Couples’ Nighttime Sleep Efficiency and Concordance: Evidence for Bidirectional Associations with Daytime Relationship Functioning 
Psychosomatic medicine  2010;72(8):794-801.
Objective
Emerging evidence suggests the existence of bidirectional links between sleep and relational processes in dyads, but to date, this research has been primarily cross-sectional. The present analyses were undertaken to prospectively examine the directionality of the association between daily relationship functioning and nightly sleep quality and the association between couples’ relationship functioning and concordance in sleep-wake rhythms.
Methods
Sleep was measured via both diaries and wrist actigraphy for 7 days in 29 heterosexual co-sleeping couples. Ecological momentary assessment methods were used to characterize daily relationship functioning. Dyadic, multilevel analyses were used to examine the degree to which nightly sleep efficiency or within-couple concordance in sleep timing predicted the next day’s relational functioning and vice versa.
Results
In the first set of analyses, for males, higher diary-based sleep efficiency predicted less negative partner interaction the following day. For females, less negative partner interaction during the day predicted greater actigraphy-based sleep efficiency that night. Furthermore, if females reported more positive and less negative daytime partner interaction during the day, this also predicted higher diary-based sleep efficiency for their male partners that night. In the second set of analyses, among females only, lower diary- or actigraphy-based sleep onset concordance respectively predicted less positive and more negative partner interactions the next day.
Conclusions
Bidirectional associations appear to exist between sleep parameters and interpersonal interaction, and may represent a novel pathway linking close relationships with physical and mental health.
doi:10.1097/PSY.0b013e3181ecd08a
PMCID: PMC2950886  PMID: 20668283
sleep; couples; relationships; relationship quality
3.  A Comparison of Actigraphy and Sleep Diaries for Infants’ Sleep Behavior 
Detecting the effectiveness of behavioral interventions to reduce infant night-waking requires valid sleep measures. Although viewed as an objective measure, actigraphy has overestimated night-waking. Sleep diaries are criticized for only documenting night-waking with infant crying. To support potential outcome measure validity, we examined differences between sleep diaries and actigraphy in detecting night-waking and sleep duration. We recruited 5.5 to 8-month-old infants for a behavioral sleep intervention trial conducted from 2009 to 2011. Intervention (sleep education and support) and control groups (safety education and support) collected infant diary and actigraphy data for 5 days. We compared night-time sleep actigraphy with diary data at baseline (194 cases), and 6 weeks (166 cases) and 24 weeks post-education (118 cases). We hypothesized numbers of wakes and wakes of ≥20 min would be higher and longest sleep time and total sleep time shorter by actigraphy compared with diaries. Using paired t-tests, there were significantly more actigraphy night wakes than diary wakes at baseline (t = 29.14, df = 193, p < 0.001), 6 weeks (t = 23.99, df = 165, p < 0.001), and 24 weeks (t = 22.01, df = 117, p < 0.001); and significantly more night wakes of ≥20 min by actigraphy than diary at baseline (t = 5.03, df = 183, p < 0.001), and 24 weeks (t = 2.19, df = 107, p < 0.05), but not 6 weeks (t = 1.37, df = 156, n.s.). Longest sleep duration was significantly higher by diary than actigraphy at baseline (t = 14.71, df = 186, p < 0.001), 6 weeks (t = 7.94, df = 158, p < 0.001), and 24 weeks (t = 17.18, df = 114, p < 0.001). Night sleep duration was significantly higher by diary than actigraphy at baseline (t = 9.46, df = 185, p < 0.001), 6 weeks (t = 13.34, df = 158, p < 0.001), and 24 weeks (t = 13.48, df = 114, p < 0.001). Discrepancies in actigraphy and diary data may indicate accurate actigraphy recording of movement but not sleep given active infant sleep and self-soothing.
doi:10.3389/fpsyt.2015.00019
PMCID: PMC4325935  PMID: 25729371
infant; sleep problems; actigraphy; sleep diaries; behavioral symptoms
4.  Development of an ecological momentary assessment scale for appetite 
Background
An understanding of eating behaviors is an important element of health education and treatment in clinical populations. To understand the biopsychosocial profile of eating behaviors in an ecologically valid way, ecological momentary assessment (EMA) is appropriate because its use is able to overcome the recall bias in patient-reported outcomes (PROs). As appetite is a key PRO associated with eating behaviors, this study was done to develop an EMA scale to evaluate the within-individual variation of momentary appetite and uses this scale to discuss the relationships between appetite and various psychological factors.
Methods
Twenty healthy participants (age 23.6 ± 4.2 years old) wore a watch-type computer for a week. Several times a day, including just before and after meals, they recorded their momentary psychological stress, mood states, and ten items related to appetite. In addition, they recorded everything they ate and drank into a personal digital assistant (PDA)-based food diary. Multilevel factor analysis was used to investigate the factor structure of the scale, and the reliability and validity of the scale were also explored.
Results
Multilevel factor analyses found two factors at the within-individual level (hunger/fullness and cravings) and one factor at the between-individual level. Medians for the individually calculated Cronbach’s alphas were 0.89 for hunger/fullness, 0.71 for cravings, and 0.86 for total appetite (the sum of all items). Hunger/fullness, cravings, and total appetite all decreased significantly after meals compared with those before meals, and hunger/fullness, cravings, and total appetite before meals were positively associated with energy intake. There were significant negative associations between both hunger/fullness and total appetite and anxiety and depression as well as between cravings, and depression, anxiety and stress.
Conclusions
The within-individual reliability of the EMA scale to assess momentary appetite was confirmed in most subjects and it was also validated as a useful tool to understand eating behaviors in daily settings. Further refinement of the scale is necessary and further investigations need to be conducted, particularly on clinical populations.
doi:10.1186/s13030-014-0029-6
PMCID: PMC4302437  PMID: 25614760
Appetite; Ecological momentary assessment; Food diary; Multilevel factor analysis
5.  Co-Variation of Depressive Mood and Locomotor Dynamics Evaluated by Ecological Momentary Assessment in Healthy Humans 
PLoS ONE  2013;8(9):e74979.
Computerized ecological momentary assessment (EMA) is widely accepted as a “gold standard” method for capturing momentary symptoms repeatedly experienced in daily life. Although many studies have addressed the within-individual temporal variations in momentary symptoms compared with simultaneously measured external criteria, their concurrent associations, specifically with continuous physiological measures, have not been rigorously examined. Therefore, in the present study, we first examined the variations in momentary symptoms by validating the associations among self-reported symptoms measured simultaneously (depressive mood, anxious mood, and fatigue) and then investigated covariant properties between the symptoms (especially, depressive mood) and local statistics of locomotor activity as the external objective criteria obtained continuously. Healthy subjects (N = 85) from three different populations (adolescents, undergraduates, and office workers) wore a watch-type computer device equipped with EMA software for recording the momentary symptoms experienced by the subjects. Locomotor activity data were also continuously obtained by using an actigraph built into the device. Multilevel modeling analysis confirmed convergent associations by showing positive correlations among momentary symptoms. The increased intermittency of locomotor activity, characterized by a combination of reduced activity with occasional bursts, appeared concurrently with the worsening of depressive mood. Further, this association remained statistically unchanged across groups regardless of group differences in age, lifestyle, and occupation. These results indicate that the temporal variations in the momentary symptoms are not random but reflect the underlying changes in psychophysiological variables in daily life. In addition, our findings on the concurrent changes in depressive mood and locomotor activity may contribute to the continuous estimation of changes in depressive mood and early detection of depressive disorders.
doi:10.1371/journal.pone.0074979
PMCID: PMC3773004  PMID: 24058642
6.  Classification and clinical features of headache patients: an outpatient clinic study from China 
The Journal of Headache and Pain  2011;12(5):561-567.
This study aimed to analyze and classify the clinical features of headache in neurological outpatients. A cross-sectional study was conducted consecutively from March to May 2010 for headache among general neurological outpatients attending the First Affiliated Hospital of Chongqing Medical University. Personal interviews were carried out and a questionnaire was used to collect medical records. Diagnosis of headache was according to the International classification of headache disorders, 2nd edition (ICHD-II). Headache patients accounted for 19.5% of the general neurology clinic outpatients. A total of 843 (50.1%) patients were defined as having primary headache, 454 (27%) secondary headache, and 386 (23%) headache not otherwise specified (headache NOS). For primary headache, 401 (23.8%) had migraine, 399 (23.7%) tension-type headache (TTH), 8 (0.5%) cluster headache and 35 (2.1%) other headache types. Overall, migraine patients suffered (1) more severe headache intensity, (2) longer than 6 years of headache history and (3) more common analgesic medications use than TTH ones (p < 0.001).TTH patients had more frequent episodes of headaches than migraine patients, and typically headache frequency exceeded 15 days/month (p < 0.001); 22.8% of primary headache patients were defined as chronic daily headache. Almost 20% of outpatient visits to the general neurology department were of headache patients, predominantly primary headache of migraine and TTH. In outpatient headaches, more attention should be given to headache intensity and duration of headache history for migraine patients, while more attention to headache frequency should be given for the TTH ones.
doi:10.1007/s10194-011-0360-2
PMCID: PMC3173628  PMID: 21744226
Outpatient; Headache; Cross-sectional study; Clinical feature; Migraine
7.  Classification and clinical features of headache patients: an outpatient clinic study from China 
The Journal of Headache and Pain  2011;12(5):561-567.
This study aimed to analyze and classify the clinical features of headache in neurological outpatients. A cross-sectional study was conducted consecutively from March to May 2010 for headache among general neurological outpatients attending the First Affiliated Hospital of Chongqing Medical University. Personal interviews were carried out and a questionnaire was used to collect medical records. Diagnosis of headache was according to the International classification of headache disorders, 2nd edition (ICHD-II). Headache patients accounted for 19.5% of the general neurology clinic outpatients. A total of 843 (50.1%) patients were defined as having primary headache, 454 (27%) secondary headache, and 386 (23%) headache not otherwise specified (headache NOS). For primary headache, 401 (23.8%) had migraine, 399 (23.7%) tension-type headache (TTH), 8 (0.5%) cluster headache and 35 (2.1%) other headache types. Overall, migraine patients suffered (1) more severe headache intensity, (2) longer than 6 years of headache history and (3) more common analgesic medications use than TTH ones (p < 0.001).TTH patients had more frequent episodes of headaches than migraine patients, and typically headache frequency exceeded 15 days/month (p < 0.001); 22.8% of primary headache patients were defined as chronic daily headache. Almost 20% of outpatient visits to the general neurology department were of headache patients, predominantly primary headache of migraine and TTH. In outpatient headaches, more attention should be given to headache intensity and duration of headache history for migraine patients, while more attention to headache frequency should be given for the TTH ones.
doi:10.1007/s10194-011-0360-2
PMCID: PMC3173628  PMID: 21744226
Outpatient; Headache; Cross-sectional study; Clinical feature; Migraine
8.  Factors associated with disability and impact of tension-type headache: findings of the Korean headache survey 
Background
Although mostly mild in symptom severity, tension-type headache (TTH) can cause disability. However, factors associated with disability of TTH have been rarely reported. This study sought to assess the factors associated with TTH-related disability and impact.
Methods
We analyzed data form the Korean Headache Survey, a nation-wide survey regarding headache in all Korean adults aged 19–69 years. TTH-related disability was measured by surveying actual disability and Headache Impact Test-6 (HIT-6). Actual disability was defined as having one or more days of activity restriction or missed activity due to headache in the last 3 months. The HIT-6 score ≥ 50 was regarded as significant headache impact associated with TTH. We assessed factors associated with TTH-related disability and impact using logistic regression analyses adjusting for sociodemographic variables and headache characteristics.
Results
Among 1507 individuals, the 1-year prevalence rate of TTH was 30.7% (n = 463), of which 4.8% reported actual disability and 21.3% had headache impact, respectively. In univariate analyses, sociodemographic variables were not associated with actual disability and headache impact, respectively. There were relationships between several headache characteristics and actual disability/headache impact. After adjustment of potential confounders, moderate headache intensity was correlated with actual disability (odds ratio [OR]: 4.41, 95% confidence interval [CI]: 1.46–13.27), while an inverse association was observed between no aggravation by routine activity and actual disability (OR: 0.32, 95% CI: 0.12–0.88). Multivariate analyses showed that ORs for headache impact were increased in those with higher headache frequency (OR: 2.54, 95% CI: 1.47–4.39 for 1–14 days/month; OR: 23.83, 95% CI: 5.46–104.03 for ≥ 15 days/month), longer headache time duration (OR: 1.84, 95% CI: 1.04–3.25 for ≥ 1 and < 4 hours; OR: 2.44 95% CI: 1.17–5.11 for ≥ 4 hours), and phonophobia (OR: 1.73, 95% CI: 1.02–2.95), whereas decreased in those with no aggravation by routine activity (OR: 0.32, 95% CI: 0.12–0.88).
Conclusions
Several headache characteristics were associated with actual disability and headache impact among TTH individuals. Our findings suggest that there needs to be consideration careful of troublesome headache characteristics for TTH individuals suffering from disability and impact.
doi:10.1186/s10194-015-0524-6
PMCID: PMC4434242  PMID: 25943683
Disability; Epidemiology; Headache; Tension-type headache
9.  Stress and Sleep Duration Predict Headache Severity in Chronic Headache Sufferers 
Pain  2012;153(12):2432-2440.
The objective of this study was to evaluate the time-series relationships between stress, sleep duration, and headache pain among patients with chronic headaches. Sleep and stress have long been recognized as potential triggers of episodic headache (< 15 headache days/month), though prospective evidence is inconsistent and absent in patients diagnosed with chronic headaches (≥ 15 days/month). We reanalyzed data from a 28-day observational study of chronic migraine (n = 33) and chronic tension-type headache (n = 22) sufferers. Patients completed the Daily Stress Inventory and recorded headache and sleep variables using a daily sleep/headache diary. Stress ratings, duration of previous nights' sleep, and headache severity were modeled using a series of linear mixed models with random effects to account for individual differences in observed associations. Models were displayed using contour plots. Two consecutive days of either high stress or low sleep were strongly predictive of headache, whereas two days of low stress or adequate sleep were protective. When patterns of stress or sleep were divergent across days, headache risk was increased only when the earlier day was characterized by high stress or poor sleep. As predicted, headache activity in the combined model was highest when high stress and low sleep occurred concurrently during the prior 2 days denoting an additive effect. Future research is needed to expand on current findings among chronic headache patients and to develop individualized models that account for multiple simultaneous influences of headache trigger factors.
doi:10.1016/j.pain.2012.08.014
PMCID: PMC3626265  PMID: 23073072
Stress; Sleep; Headache; Time-series; Headache trigger factors; Headache precipitants
10.  Exercise Effects on Night-to-Night Fluctuations in Self-rated Sleep among Older Adults with Sleep Complaints 
Journal of sleep research  2011;20(1 Pt 1):28-37.
Sleep interventions have rarely explored reductions in night-to-night fluctuations (i.e., intra-individual variability [IIV]) in sleep, despite the negative impacts of such fluctuations on affective states and cognitive and physical symptoms. In a community-based randomized controlled trial we evaluated whether physical exercise reduced IIV in self-rated sleep outcomes among middle-aged and older adults with sleep complaints. Under-active adults 55 years and older (N=66, 67% women) with mild to moderate sleep complaints were randomized to 12mos of a moderate-intensity endurance exercise (n=36) or a health education control group (n=30). Daily sleep logs, Pittsburgh Sleep Quality Index (PSQI), and in-home polysomnographic sleep recordings (PSG) were collected at baseline, 6mos, and 12mos. Sleep log-derived means and IIV were computed for sleep-onset latency (SOL), time in bed (TIB), feeling rested in the morning, number of nighttime awakenings, and wake after final awakening (WAFA). Using intent-to-treat methods, at 6mos no differences in IIV were observed by group. At 12mos, SOL-based IIV was reduced in the exercise group compared to the control (difference=23.11, 95% CI: 3.04–47.18, p=.025, Cohen’s d=0.57). This change occurred without mean-level or IIV changes in sleep-wake schedules. For all sleep variables except SOL and WAFA, IIV changes and mean-level changes in each variable were negatively correlated (r’s=−.312 to −.691, p’s<.05). Sleep log-derived IIV changes were modestly correlated with mean-level PSQI and PSG-based changes at 12mos. Twelve months of moderate-intensity exercise reduced night-to-night fluctuations in self-rated time to fall asleep, and this relationship was independent of mean-level time to fall asleep.
doi:10.1111/j.1365-2869.2010.00866.x
PMCID: PMC2958223  PMID: 20629937
Intra-individual variability; sleep; physical activity; intervention; unpredictability; sleep-onset latency
11.  Other primary headaches 
Annals of Indian Academy of Neurology  2012;15(Suppl 1):S66-S71.
The ‘Other Primary Headaches’ include eight recognised benign headache disorders. Primary stabbing headache is a generally benign disorder which often co-exists with other primary headache disorders such as migraine and cluster headache. Primary cough headache is headache precipitated by valsalva; secondary cough has been reported particularly in association with posterior fossa pathology. Primary exertional headache can occur with sudden or gradual onset during, or immediately after, exercise. Similarly headache associated with sexual activity can occur with gradual evolution or sudden onset. Secondary headache is more likely with both exertional and sexual headache of sudden onset. Sudden onset headache, with maximum intensity reached within a minute, is termed thunderclap headache. A benign form of thunderclap headache exists. However, isolated primary and secondary thunderclap headache cannot be clinically differentiated. Therefore all headache of thunderclap onset should be investigated. The primary forms of the aforementioned paroxysmal headaches appear to be Indomethacin sensitive disorders. Hypnic headache is a rare disorder which is termed ‘alarm clock headache’, exclusively waking patients from sleep. The disorder can be Indomethacin responsive, but can also respond to Lithium and caffeine. New daily persistent headache is a rare and often intractable headache which starts one day and persists daily thereafter for at least 3 months. The clinical syndrome more often has migrainous features or is otherwise has a chronic tension-type headache phenotype. Management is that of the clinical syndrome. Hemicrania continua straddles the disorders of migraine and the trigeminal autonomic cephalalgias and is not dealt with in this review.
doi:10.4103/0972-2327.100012
PMCID: PMC3444217  PMID: 23024566
Cough headache; exertional headache; hypnic headache; primary headache disorders; stabbing headache
12.  Approaches to Measure Sleep-Wake Disturbances in Adolescents with Cancer 
Journal of pediatric nursing  2008;24(4):255-269.
Sleep-wake disturbances commonly occur in healthy adolescents. While diminished sleep and sleepiness seem normal for healthy adolescents, adolescents with chronic illnesses face additional disruption in the quantity and quality of their sleep as a result of the disease process, ongoing treatment, and associated symptoms. Little is known about how sleep in adolescents is affected by cancer, cancer treatment, and concurrent symptoms or about the consequences of sleep disruption for these patients. Although there is limited evidence to guide sleep measurement in adolescents with cancer, researchers may learn effective strategies from sleep studies completed with adolescents with other conditions. This systematic review examines how researchers have measured sleep using actigraphy, diary, and/or self-report questionnaires in diverse samples of healthy and ill adolescents. Psychometric properties are reported for nine self-report sleep questionnaires that were used in studies with mostly healthy adolescent samples. Nineteen studies provide evidence that actigraphy can be successfully and reliably used as an effective objective method to measure sleep in adolescents, including those with chronic illness. Daily sleep diaries were used less frequently to collect data from adolescents. The suitability of these techniques for the study of cancer-related sleep-wake disturbances in adolescents as well as strategies to enhance the reliability, validity, and feasibility of these measures will be discussed. Future sleep research in adolescents affected by cancer can be strengthened by the consistent use of sleep terminology, measurement of key sleep parameters, and efforts to develop and use psychometrically sound instruments. Oncology clinicians should be ready to add emerging evidence from sleep research to their care of adolescents with cancer.
doi:10.1016/j.pedn.2008.03.004
PMCID: PMC2752640  PMID: 19632503
13.  Neuroimaging for the Evaluation of Chronic Headaches 
Executive Summary
Objective
The objectives of this evidence based review are:
i) To determine the effectiveness of computed tomography (CT) and magnetic resonance imaging (MRI) scans in the evaluation of persons with a chronic headache and a normal neurological examination.
ii) To determine the comparative effectiveness of CT and MRI scans for detecting significant intracranial abnormalities in persons with chronic headache and a normal neurological exam.
iii) To determine the budget impact of CT and MRI scans for persons with a chronic headache and a normal neurological exam.
Clinical Need: Condition and Target Population
Headaches disorders are generally classified as either primary or secondary with further sub-classifications into specific headache types. Primary headaches are those not caused by a disease or medical condition and include i) tension-type headache, ii) migraine, iii) cluster headache and, iv) other primary headaches, such as hemicrania continua and new daily persistent headache. Secondary headaches include those headaches caused by an underlying medical condition. While primary headaches disorders are far more frequent than secondary headache disorders, there is an urge to carry out neuroimaging studies (CT and/or MRI scans) out of fear of missing uncommon secondary causes and often to relieve patient anxiety.
Tension type headaches are the most common primary headache disorder and migraines are the most common severe primary headache disorder. Cluster headaches are a type of trigeminal autonomic cephalalgia and are less common than migraines and tension type headaches. Chronic headaches are defined as headaches present for at least 3 months and lasting greater than or equal to 15 days per month. The International Classification of Headache Disorders states that for most secondary headaches the characteristics of the headache are poorly described in the literature and for those headache disorders where it is well described there are few diagnostically important features.
The global prevalence of headache in general in the adult population is estimated at 46%, for tension-type headache it is 42% and 11% for migraine headache. The estimated prevalence of cluster headaches is 0.1% or 1 in 1000 persons. The prevalence of chronic daily headache is estimated at 3%.
Neuroimaging
Computed Tomography
Computed tomography (CT) is a medical imaging technique used to aid diagnosis and to guide interventional and therapeutic procedures. It allows rapid acquisition of high-resolution three-dimensional images, providing radiologists and other physicians with cross-sectional views of a person’s anatomy. CT scanning poses risk of radiation exposure. The radiation exposure from a conventional CT scanner may emit effective doses of 2-4mSv for a typical head CT.
Magnetic Resonance Imaging
Magnetic resonance imaging (MRI) is a medical imaging technique used to aid diagnosis but unlike CT it does not use ionizing radiation. Instead, it uses a strong magnetic field to image a person’s anatomy. Compared to CT, MRI can provide increased contrast between the soft tissues of the body. Because of the persistent magnetic field, extra care is required in the magnetic resonance environment to ensure that injury or harm does not come to any personnel while in the environment.
Research Questions
What is the effectiveness of CT and MRI scanning in the evaluation of persons with a chronic headache and a normal neurological examination?
What is the comparative effectiveness of CT and MRI scanning for detecting significant intracranial abnormality in persons with chronic headache and a normal neurological exam?
What is the budget impact of CT and MRI scans for persons with a chronic headache and a normal neurological exam.
Research Methods
Literature Search
Search Strategy
A literature search was performed on February 18, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) for studies published from January, 2005 to February, 2010. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search. Articles with an unknown eligibility were reviewed with a second clinical epidemiologist and then a group of epidemiologists until consensus was established.
Inclusion Criteria
Systematic reviews, randomized controlled trials, observational studies
Outpatient adult population with chronic headache and normal neurological exam
Studies reporting likelihood ratio of clinical variables for a significant intracranial abnormality
English language studies
2005-present
Exclusion Criteria
Studies which report outcomes for persons with seizures, focal symptoms, recent/new onset headache, change in presentation, thunderclap headache, and headache due to trauma
Persons with abnormal neurological examination
Case reports
Outcomes of Interest
Primary Outcome
Probability for intracranial abnormality
Secondary Outcome
Patient relief from anxiety
System service use
System costs
Detection rates for significant abnormalities in MRI and CT scans
Summary of Findings
Effectiveness
One systematic review, 1 small RCT, and 1 observational study met the inclusion and exclusion criteria. The systematic review completed by Detsky, et al. reported the likelihood ratios of specific clinical variables to predict significant intracranial abnormalities. The RCT completed by Howard et al., evaluated whether neuroimaging persons with chronic headache increased or reduced patient anxiety. The prospective observational study by Sempere et al., provided evidence for the pre-test probability of intracranial abnormalities in persons with chronic headache as well as minimal data on the comparative effectiveness of CT and MRI to detect intracranial abnormalities.
Outcome 1: Pre-test Probability.
The pre-test probability is usually related to the prevalence of the disease and can be adjusted depending on the characteristics of the population. The study by Sempere et al. determined the pre-test probability (prevalence) of significant intracranial abnormalities in persons with chronic headaches defined as headache experienced for at least a 4 week duration with a normal neurological exam. There is a pre-test probability of 0.9% (95% CI 0.5, 1.4) in persons with chronic headache and normal neurological exam. The highest pre-test probability of 5 found in persons with cluster headaches. The second highest, that of 3.7, was reported in persons with indeterminate type headache. There was a 0.75% rate of incidental findings.
Likelihood ratios for detecting a significant abnormality
Clinical findings from the history and physical may be used as screening test to predict abnormalities on neuroimaging. The extent to which the clinical variable may be a good predictive variable can be captured by reporting its likelihood ratio. The likelihood ratio provides an estimate of how much a test result will change the odds of having a disease or condition. The positive likelihood ratio (LR+) tells you how much the odds of having the disease increases when a test is positive. The negative likelihood ratio (LR-) tells you how much the odds of having the disease decreases when the test is negative.
Detsky et al., determined the likelihood ratio for specific clinical variable from 11 studies. There were 4 clinical variables with both statistically significant positive and negative likelihood ratios. These included: abnormal neurological exam (LR+ 5.3, LR- 0.72), undefined headache (LR+ 3.8, LR- 0.66), headache aggravated by exertion or valsalva (LR+ 2.3, LR- 0.70), and headache with vomiting (LR+ 1.8, and LR- 0.47). There were two clinical variables with a statistically significant positive likelihood ratio and non significant negative likelihood ratio. These included: cluster-type headache (LR+ 11, LR- 0.95), and headache with aura (LR+ 12.9, LR- 0.52). Finally, there were 8 clinical variables with both statistically non significant positive and negative likelihood ratios. These included: headache with focal symptoms, new onset headache, quick onset headache, worsening headache, male gender, headache with nausea, increased headache severity, and migraine type headache.
Outcome 2: Relief from Anxiety
Howard et al. completed an RCT of 150 persons to determine if neuroimaging for headaches was anxiolytic or anxiogenic. Persons were randomized to receiving either an MRI scan or no scan for investigation of their headache. The study population was stratified into those persons with a Hospital Anxiety and Depression scale (HADS) > 11 (the high anxiety and depression group) and those < 11 (the low anxiety and depression) so that there were 4 groups:
Group 1: High anxiety and depression, no scan group
Group 2: High anxiety and depression, scan group
Group 3: Low anxiety and depression, no scan group
Group 4: Low anxiety and depression, scan group
Anxiety
There was no evidence for any overall reduction in anxiety at 1 year as measured by a visual analogue scale of ‘level of worry’ when analysed by whether the person received a scan or not. Similarly, there was no interaction between anxiety and depression status and whether a scan was offered or not on patient anxiety. Anxiety did not decrease at 1 year to any statistically significant degree in the high anxiety and depression group (HADS positive) compared with the low anxiety and depression group (HADS negative).
There are serious methodological limitations in this study design which may have contributed to these negative results. First, when considering the comparison of ‘scan’ vs. ‘no scan’ groups, 12 people (16%) in the ‘no scan group’ actually received a scan within the follow up year. If indeed scanning does reduce anxiety then this contamination of the ‘no scan’ group may have reduced the effect between the groups results resulting in a non significant difference in anxiety scores between the ‘scanned’ and the ‘no scan’ group. Second, there was an inadequate sample size at 1 year follow up in each of the 4 groups which may have contributed to a Type II statistical error (missing a difference when one may exist) when comparing scan vs. no scan by anxiety and depression status. Therefore, based on the results and study limitations it is inconclusive as to whether scanning reduces anxiety.
Outcome 3: System Services
Howard et al., considered services used and system costs a secondary outcome. These were determined by examining primary care case notes at 1 year for consultation rates, symptoms, further investigations, and contact with secondary and tertiary care.
System Services
The authors report that the use of neurologist and psychiatrist services was significantly higher for those persons not offered as scan, regardless of their anxiety and depression status (P<0.001 for neurologist, and P=0.033 for psychiatrist)
Outcome 4: System Costs
System Costs
There was evidence of statistically significantly lower system costs if persons with high levels of anxiety and depression (Hospital Anxiety and Depression Scale score >11) were provided with a scan (P=0.03 including inpatient costs, and 0.047 excluding inpatient costs).
Comparative Effectiveness of CT and MRI Scans
One study reported the detection rate for significant intracranial abnormalities using CT and MRI. In a cohort of 1876 persons with a non acute headache defined as any type of headache that had begun at least 4 weeks before enrolment Sempere et al. reported that the detection rate was 19/1432 (1.3%) using CT and 4/444 (0.9%) using MRI. Of 119 normal CT scans 2 (1.7%) had significant intracranial abnormality on MRI. The 2 cases were a small meningioma, and an acoustic neurinoma.
Summary
The evidence presented can be summarized as follows:
Pre-test Probability
Based on the results by Sempere et al., there is a low pre-test probability for intracranial abnormalities in persons with chronic headaches and a normal neurological exam (defined as headaches experiences for a minimum of 4 weeks). The Grade quality of evidence supporting this outcome is very low.
Likelihood Ratios
Based on the systematic review by Detsky et al., there is a statistically significant positive and negative likelihood ratio for the following clinical variables: abnormal neurological exam, undefined headache, headache aggravated by exertion or valsalva, headache with vomiting. Grade quality of evidence supporting this outcome is very low.
Based on the systematic review by Detsky et al. there is a statistically significant positive likelihood ratio but non statistically significant negative likelihood ratio for the following clinical variables: cluster headache and headache with aura. The Grade quality of evidence supporting this outcome is very low.
Based on the systematic review by Detsky et al., there is a non significant positive and negative likelihood ratio for the following clinical variables: headache with focal symptoms, new onset headache, quick onset headache, worsening headache, male gender, headache with nausea, increased headache severity, migraine type headache. The Grade quality of evidence supporting this outcome is very low.
Relief from Anxiety
Based on the RCT by Howard et al., it is inconclusive whether neuroimaging scans in persons with a chronic headache are anxiolytic. The Grade quality of evidence supporting this outcome is low.
System Services
Based on the RCT by Howard et al. scanning persons with chronic headache regardless of their anxiety and/or depression level reduces service use. The Grade quality of evidence is low.
System Costs
Based on the RCT by Howard et al., scanning persons with a score greater than 11 on the High Anxiety and Depression Scale reduces system costs. The Grade quality of evidence is moderate.
Comparative Effectiveness of CT and MRI Scans
There is sparse evidence to determine the relative effectiveness of CT compared with MRI scanning for the detection of intracranial abnormalities. The Grade quality of evidence supporting this is very low.
Economic Analysis
Ontario Perspective
Volumes for neuroimaging of the head i.e. CT and MRI scans, from the Ontario Health Insurance Plan (OHIP) data set were used to investigate trends in the province for Fiscal Years (FY) 2004-2009.
Assumptions were made in order to investigate neuroimaging of the head for the indication of headache. From the literature, 27% of all CT and 13% of all MRI scans for the head were assumed to include an indication of headache. From that same retrospective chart review and personal communication with the author 16% of CT scans and 4% of MRI scans for the head were for the sole indication of headache. From the Ministry of Health and Long-Term Care (MOHLTC) wait times data, 73% of all CT and 93% of all MRI scans in the province, irrespective of indication were outpatient procedures.
The expenditure for each FY reflects the volume for that year and since volumes have increased in the past 6 FYs, the expenditure has also increased with a pay-out reaching 3.0M and 2.8M for CT and MRI services of the head respectively for the indication of headache and a pay-out reaching 1.8M and 0.9M for CT and MRI services of the head respectively for the indication of headache only in FY 08/09.
Cost per Abnormal Finding
The yield of abnormal finding for a CT and MRI scan of the head for the indication of headache only is 2% and 5% respectively. Based on these yield a high-level estimate of the cost per abnormal finding with neuroimaging of the head for headache only can be calculated for each FY. In FY 08/09 there were 37,434 CT and 16,197 MRI scans of the head for headache only. These volumes would generate a yield of abnormal finding of 749 and 910 with a CT scan and MRI scan respectively. The expenditure for FY 08/09 was 1.8M and 0.9M for CT and MRI services respectively. Therefore the cost per abnormal finding would be $2,409 for CT and $957 for MRI. These cost per abnormal finding estimates were limited because they did not factor in comparators or the consequences associated with an abnormal reading or FNs. The estimates only consider the cost of the neuroimaging procedure and the yield of abnormal finding with the respective procedure.
PMCID: PMC3377587  PMID: 23074404
14.  Assessment of Sleep in Children with Mucopolysaccharidosis Type III 
PLoS ONE  2014;9(2):e84128.
Sleep disturbances are prevalent in mucopolysaccharidosis Type III (MPS III), yet there is a lack of objective, ecologically valid evidence detailing sleep quantity, quality or circadian system. Eight children with MPS III and eight age-matched typically developing children wore an actigraph for 7–10 days/nights. Saliva samples were collected at three time-points on two separate days, to permit analysis of endogenous melatonin levels. Parents completed a sleep questionnaire and a daily sleep diary. Actigraphic data revealed that children with MPS III had significantly longer sleep onset latencies and greater daytime sleep compared to controls, but night-time sleep duration did not differ between groups. In the MPS III group, sleep efficiency declined, and sleep onset latency increased, with age. Questionnaire responses showed that MPS III patients had significantly more sleep difficulties in all domains compared to controls. Melatonin concentrations showed an alteration in the circadian system in MPS III, which suggests that treatment for sleep problems should attempt to synchronise the sleep-wake cycle to a more regular pattern. Actigraphy was tolerated by children and this monitoring device can be recommended as a measure of treatment success in research and clinical practice.
doi:10.1371/journal.pone.0084128
PMCID: PMC3913580  PMID: 24504123
15.  Daytime Symptoms in Primary Insomnia: A Prospective Analysis Using Ecological Momentary Assessment 
Sleep medicine  2007;8(3):198-208.
Objectives
To prospectively characterize and compare daytime symptoms in primary insomnia (PI) and good sleeper control (GSC) subjects using ecological momentary assessment; to examine relationships between daytime symptom factors, retrospective psychological and sleep reports, and concurrent sleep diary reports.
Methods
Subjects included 47 PI and 18 GSC. Retrospective self-reports of daytime and sleep symptoms were collected. Daytime symptoms and sleep diary information were then collected for one week on hand-held computers. The Daytime Insomnia Symptom Scale (DISS) consisted of 19 visual analog scales completed four times per day. Factors for the DISS were derived using functional principal components analysis. Nonparametric tests were used to contrast DISS, retrospective symptom ratings, and sleep diary results in PI and GSC subjects, and to examine relationships among them.
Results
Four principal components were identified for the DISS: Alert Cognition, Negative Mood, Positive Mood, and Sleepiness/Fatigue. PI scored significantly worse than GSC on all four factors (p < .0003 for each). Among PI subjects DISS scales and retrospective psychological symptoms were related to each other in plausible ways. DISS factors were also related to self-report measures of sleep, whereas retrospective psychological symptom measures were not.
Conclusions
Daytime symptom factors of alertness, positive and negative mood, and sleepiness/fatigue, collected with ecological momentary assessment, showed impairment in PI versus GSC. DISS factors showed stronger relationships to retrospective sleep symptoms and concurrent sleep diary reports than retrospective psychological symptoms. The diurnal pattern of symptoms may inform studies of the pathophysiology and treatment outcome of insomnia.
doi:10.1016/j.sleep.2006.10.006
PMCID: PMC1899354  PMID: 17368098
insomnia; ecological momentary assessment; experience sampling; symptoms; diary
16.  Impact of primary headaches on subjective sleep parameters among adolescents 
Context:
Headache patients commonly report sleep disruption and sleep disorders. Available literature suggests that the sleep pattern of headache sufferers is different from the control group. Patients in these studies were recruited from headache clinics; they did not include tension type headache.
Aims:
The aim of this study is to find out whether primary headaches affect sleep patterns.
Settings and Design:
Community based cross sectional study
Materials and Methods:
This study was conducted in three high schools. Children in the 12-19 age group were allowed to participate. They were given a questionnaire in the presence of at least one of the authors, who assisted them in filling it. They were asked to provide responses based on most severe recurrent headache that they had experienced rather than the more frequent ones. The questionnaire included questions regarding demographic data and the characteristics of headache according to International Classification of Headache Disorders-2 criteria. Part B of the questionnaire contained questions regarding sleep habits. The children were asked to provide data regarding sleep habits on a normal school day. Diagnosis was based upon the information contained in the questionnaire. A telephonic interview was also done, where the information provided was found inadequate.
Statistical Analysis Used:
Analysis was done with the help of SPSS v. 11.0., descriptive analysis, Chi square, and one way ANOVA with post hoc analysis. Kruskall-Wallis tests were run.
Results:
A total of 1862 subjects were included in the study. Migraineurs and tension type headache sufferers comprised 35.7% and 13.4% of the group respectively. Migraineurs had the highest prevalence of nocturnal awakenings (P < 0.001), abnormal movements (P=0.001) and breathing problems during sleep (P < 0.001). Approximately half the migraineurs felt sleepy during the day (P< 0.001) and spent around 1.17 hours in sleep during the day (P = 0.007). Similarly, values for frequency of nocturnal awakenings per week (P < 0.001), wake time after sleep onset and offset (P < 0.001 and 0.002 respectively) were the maximum in migraineurs. Only 32.8% migraineurs reported refreshing sleep (P< 0.001). Post hoc analysis revealed that migraineurs were different from the other two groups on most of the parameters.
Conclusions:
Sleep disruption is more common in migraineurs than those in the tension type headache sufferers and the control group.
doi:10.4103/0972-2327.42936
PMCID: PMC2771978  PMID: 19893663
Migraine; sleep; sleep-disruption; tension type headache
17.  Relationship between insomnia and headache in community-based middle-aged Hong Kong Chinese women 
The Journal of Headache and Pain  2010;11(3):187-195.
Limited studies have investigated the prevalence of insomnia symptoms among individuals with different headache diagnoses and the association between insomnia and headache in subjects with comorbid anxiety and depression. A total of 310 community-dwelling Hong Kong Chinese women aged 40–60 years completed a self-administered questionnaire on headache, sleep difficulties, mood disturbances, and functional impairment. About 31% of the sample complained of recurrent headache unrelated to influenza and the common cold in the past 12 months. The percentages of women diagnosed to have migraine, tension-type headache (TTH), and headache unspecified were 8.4, 15.5 and 7.1%, respectively. The most frequent insomnia complaint was “problem waking up too early” (29.4%), followed by “difficulty staying asleep” (28.0%) and “difficulty falling asleep” (24.4%). Women with headaches were significantly more likely to report insomnia symptoms than those without headaches. There were no significant differences among women with migraine, TTH, and headache unspecified in the prevalence of insomnia symptoms. Logistic regression analysis showed that women with insomnia disorder as defined by an insomnia severity index total score ≥8 had 2.2-fold increased risk of reporting recurrent headache, 3.2-fold increased risk of migraine, and 2.3-fold increased risk of TTH, after adjusting for anxiety and depression. Individual insomnia symptoms were not independent predictors. The association between insomnia and headache was stronger in subjects with more frequent headaches. Our findings suggest that insomnia and the associated distress, but not insomnia symptoms alone, is an independent risk factor for recurrent headache in middle-aged women with mixed anxiety, depression and sleep disturbances.
doi:10.1007/s10194-010-0199-y
PMCID: PMC3451911  PMID: 20186559
Anxiety; Depression; Headache; Insomnia; Migraine; Tension-type headache
18.  Risk factors for migraine and tension-type headache in 11 year old children 
Background
Though migraine and tension type headache are both commonly diagnosed in childhood, little is known about their determinants when diagnosed prior to puberty onset. Our aim was to determine psychosocial- and health-related risk factors of migraine and tension-type headache in 11 year old children.
Methods
871 New Zealand European children were enrolled in a longitudinal study at birth and data were collected at birth, 1, 3.5, 7, and 11 years of age. Primary headache was determined at age 11 years based on the International Headache Society. Perinatal factors assessed were small for gestational age status, sex, maternal smoking during pregnancy, maternal perceived stress, and maternal school leaving age. Childhood factors assessed were sleep duration, percent body fat, television watching, parent and self-reported total problem behaviour, being bullied, and depression.
Results
Prevalence of migraine and tension-type headache was 10.5% and 18.6%, respectively. Both migraine and TTH were significantly associated with self-reported problem behaviour in univariable logistic regression analyses. Additionally, migraine was associated with reduced sleep duration, and both sleep and behaviour problems remained significant after multivariable analyses. TTH was also significantly associated with antenatal maternal smoking, higher body fat, and being bullied. For TTH, problem behaviour measured at ages 3.5 and 11 years both remained significant after multivariable analysis. Being born small for gestational age was not associated with either headache group.
Conclusions
Although they share some commonality, migraine and tension-type headache are separate entities in childhood with different developmental characteristics. The association between primary headache and problem behaviour requires further investigation.
doi:10.1186/1129-2377-15-60
PMCID: PMC4162739  PMID: 25205384
Migraine; Tension-type; Paediatrics; Small for gestational age; Longitudinal; Risk-factors; Paediatric
19.  Sleep and Daily Functioning during Androgen Deprivation Therapy for Prostate Cancer 
European journal of cancer care  2010;20(4):549-554.
A limited body of evidence suggests that sleep problems are common in prostate cancer patients undergoing androgen deprivation therapy, yet little is known about sleep characteristics and the effects of poor sleep on daily functioning in this population. This study assessed sleep in 60 prostate cancer patients taking androgen deprivation therapy with wrist actigraphy and daily diaries for 7 days. The Epworth Sleepiness Scale and the general version of the Functional Assessment of Cancer Therapy scale were also administered. On average, total sleep time was 5.9 (SD = 1.4) hours, and sleep efficiency was 75.0 percent (SD = 12.0) as assessed by actigraphy. There was generally poor concordance between actigraphy and daily diary for most sleep metrics. Subjects reported awakening, on average, 2.7 times per night, most commonly for nocturia and hot flashes. Assessment of daily functioning showed that participants had mild daytime sleepiness, which was predicted by total sleep time (F(1,47) = 4.5, p = .04). General quality of life was not impaired. This study supports more research on the predictors of poor sleep in order to identify effective interventions.
doi:10.1111/j.1365-2354.2010.01226.x
PMCID: PMC3017240  PMID: 20825464
Prostate cancer; hormonal therapy; sleep; actigraphy; nocturia
20.  Is There a Relation between Tension-Type Headache, Temporomandibular Disorders and Sleep? 
Pain Research and Treatment  2013;2013:845684.
Introduction. Tension-Type Headache (TTH) is the most prevalent headache often associated with impaired function and quality of life. Temporomandibular Disorders (TMD) and TTH frequently coexist; characterized by pericranial tenderness and impact on daily life. We aim to apply a standardized questionnaire for TMD to characterize and analyse an eventual relation between sleep and oral health in TTH in a controlled design. Material and Methods. 58 consecutive TTH patients and 58 healthy controls were included. The Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) questionnaire, Oral Health Impact profile (OHIP) and questionnaires for sleep were applied. Results. TTH-patients had significantly higher pain scores (P < 0.001), decreased quality of life (P < 0.001), and higher total sleep scores (P < 0.001) compared to controls. Conclusion. For the first time we have identified a clear relation between TTH and TMD symptoms, depression, anxiety, poor sleep, and impairments of oral function in carefully classified patients. These findings indicate a close, but incomplete, overlap between TTH and TMD. Their underlying pathophysiological mechanisms need further research.
doi:10.1155/2013/845684
PMCID: PMC3856154  PMID: 24349777
21.  Evaluating sleep in bipolar disorder: comparison between actigraphy, polysomnography, and sleep diary 
Bipolar disorders  2012;14(8):870-879.
Objectives
Bipolar disorder is an illness characterized by sleep and circadian disturbance, and monitoring sleep in this population may signal an impending mood change. Actigraphy is an important clinical and research tool for examining sleep, but has not yet been systematically compared to polysomnography or sleep diary in bipolar disorder. The present study compares actigraphy, polysomnography, and sleep diary estimates of five standard sleep parameters in individuals with bipolar disorder and matched controls across two nights of assessment.
Methods
Twenty-seven individuals who met diagnostic criteria for bipolar disorder type I or II and were currently between mood episodes, along with 27 matched controls with no history of psychopathology or sleep disturbance, underwent two nights of research laboratory monitoring. Sleep was estimated via polysomnography, actigraphy, and sleep diary.
Results
Over the 108 nights available for comparison, sleep parameter estimates from actigraphy and polysomnography were highly correlated and did not differ between the two groups or across the two nights for sleep onset latency, wake after sleep onset, number of awakenings, total sleep time, or sleep efficiency percentage. The medium wake threshold algorithm in the actigraphy software was the most concordant with polysomnography and diaries across the five sleep parameters. Concordance between actigraphy, polysomnography, and sleep diary was largely independent of insomnia presence and medication use.
Conclusions
Actigraphy is a valid tool for estimating sleep length and fragmentation in bipolar disorder.
doi:10.1111/bdi.12021
PMCID: PMC3549461  PMID: 23167935
actigraphy; bipolar disorder; polysomnography; sleep; sleep diary
22.  Characterisation of sleep in intensive care using 24-hour polysomnography: an observational study 
Critical Care  2013;17(2):R46.
Introduction
Many intensive care patients experience sleep disruption potentially related to noise, light and treatment interventions. The purpose of this study was to characterise, in terms of quantity and quality, the sleep of intensive care patients, taking into account the impact of environmental factors.
Methods
This observational study was conducted in the adult ICU of a tertiary referral hospital in Australia, enrolling 57 patients. Polysomnography (PSG) was performed over a 24-hour period to assess the quantity (total sleep time: hh:mm) and quality (percentage per stage, duration of sleep episode) of patients' sleep while in ICU. Rechtschaffen and Kales criteria were used to categorise sleep. Interrater checks were performed. Sound pressure and illuminance levels and care events were simultaneously recorded. Patients reported on their sleep quality in ICU using the Richards Campbell Sleep Questionnaire and the Sleep in Intensive Care Questionnaire. Data were summarised using frequencies and proportions or measures of central tendency and dispersion as appropriate and Cohen's Kappa statistic was used for interrater reliability of the sleep data analysis.
Results
Patients' median total sleep time was 05:00 (IQR: 02:52 to 07:14). The majority of sleep was stage 1 and 2 (medians: 19 and 73%) with scant slow wave and REM sleep. The median duration of sleep without waking was 00:03. Sound levels were high (mean Leq 53.95 dB(A) during the day and 50.20 dB(A) at night) and illuminance levels were appropriate at night (median <2 lux) but low during the day (median: 74.20 lux). There was a median 1.7 care events/h. Patients' mean self-reported sleep quality was poor. Interrater reliability of sleep staging was highest for slow wave sleep and lowest for stage 1 sleep.
Conclusions
The quantity and quality of sleep in intensive care patients are poor and may be related to noise, critical illness itself and treatment events that disturb sleep. The study highlights the challenge of quantifying sleep in the critical care setting and the need for alternative methods of measuring sleep. The results suggest that a sound reduction program is required and other interventions to improve clinical practices to promote sleep in intensive care patients.
Trial registration
Australian New Zealand clinical trial registry (http://www.anzctr.org.au/): ACTRN12610000688088.
doi:10.1186/cc12565
PMCID: PMC3733429  PMID: 23506782
23.  Validation of actigraphy to assess circadian organization and sleep quality in patients with advanced lung cancer 
Background
Many cancer patients report poor sleep quality, despite having adequate time and opportunity for sleep. Satisfying sleep is dependent on a healthy circadian time structure and the circadian patterns among cancer patients are quite abnormal. Wrist actigraphy has been validated with concurrent polysomnography as a reliable tool to objectively measure many standard sleep parameters, as well as daily activity. Actigraphic and subjective sleep data are in agreement when determining activity-sleep patterns and sleep quality/quantity, each of which are severely affected in cancer patients. We investigated the relationship between actigraphic measurement of circadian organization and self-reported subjective sleep quality among patients with advanced lung cancer.
Methods
This cross-sectional and case control study was conducted in 84 patients with advanced non-small cell lung cancer in a hospital setting for the patients at Midwestern Regional Medical Center (MRMC), Zion, IL, USA and home setting for the patients at WJB Dorn Veterans Affairs Medical Center (VAMC), Columbia, SC, USA. Prior to chemotherapy treatment, each patient's sleep-activity cycle was measured by actigraphy over a 4-7 day period and sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI) questionnaire.
Results
The mean age of our patients was 62 years. 65 patients were males while 19 were females. 31 patients had failed prior treatment while 52 were newly diagnosed. Actigraphy and PSQI scores showed significantly disturbed daily sleep-activity cycles and poorer sleep quality in lung cancer patients compared to healthy controls. Nearly all actigraphic parameters strongly correlated with PSQI self-reported sleep quality of inpatients and outpatients.
Conclusions
The correlation of daily activity/sleep time with PSQI-documented sleep indicates that actigraphy can be used as an objective tool and/or to complement subjective assessments of sleep quality in patients with advanced lung cancer. These results suggest that improvements to circadian function may also improve sleep quality.
doi:10.1186/1740-3391-9-4
PMCID: PMC3113323  PMID: 21592392
24.  Changes in Clinical Parameters in Patients with Tension-type Headache Following Massage Therapy: A Pilot Study 
Complementary and alternative medicine approaches to treatment for tension-type headache are increasingly popular among patients, but evidence supporting its efficacy is limited. The objective of this study was to assess short term changes on primary and secondary headache pain measures in patients with tension-type headache (TTH) receiving a structured massage therapy program with a focus on myofascial trigger point therapy. Participants were enrolled in an open label trial using a baseline control with four 3-week phases: baseline, massage (two 3-week phases) and follow-up. Twice weekly, 45-minute massage sessions commenced following the baseline phase. A daily headache diary was maintained throughout the study in which participants recorded headache incidence, intensity, and duration. The Headache Disability Index was administered upon study entry and at 3-week intervals thereafter. 18 subjects were enrolled with 16 completing all headache diary, evaluation, and massage assignments. Study participants reported a median of 7.5 years with TTH. Headache frequency decreased from 4.7±0.7 episodes per week during baseline to 3.7±0.9 during treatment period 2 (P<0.001); reduction was also noted during the follow-up phase (3.2±1.0). Secondary measures of headache also decreased across the study phases with headache intensity decreasing by 30% (P<0.01) and headache duration from 4.0±1.3 to 2.8±0.5 hours (P<0.05). A corresponding improvement in Headache Disability Index was found with massage (P<0.001). This pilot study provides preliminary evidence for reduction in headache pain and disability with massage therapy that targets myofascial trigger points, suggesting the need for more rigorously controlled studies.
PMCID: PMC2565109  PMID: 19119396
Complementary and Alternative Medicine; Headache Disability Index; Manual Therapy; Myofasical Pain; Myofascial Trigger Points
25.  Objective and subjective assessment of sleep in chronic low back pain patients compared with healthy age and gender matched controls: a pilot study 
Background
While approximately 70% of chronic low back pain (CLBP) sufferers complain of sleep disturbance, current literature is based on self report measures which can be prone to bias and no objective data of sleep quality, based exclusively on CLBP are available. In accordance with the recommendations of The American Sleep Academy, when measuring sleep, both subjective and objective assessments should be considered as the two are only modestly correlated, suggesting that each modality assesses different aspects of an individual's sleep experience. Therefore, the purpose of this study was to expand previous research into sleep disturbance in CLBP by comparing objective and subjective sleep quality in participants with CLBP and healthy age and gender matched controls, to identify correlates of poor sleep and to test logistics and gather information prior to a larger study.
Methods
15 CLBP participants (mean age = 43.8 years (SD = 11.5), 53% female) and 15 healthy controls (mean age = 41.5 years (SD = 10.6), 53% female) consented. All participants completed the Pittsburgh Sleep Quality Index, Insomnia Severity Index, Pittsburgh Sleep Diary and the SF36v2. CLBP participants also completed the Oswestry Disability Index. Sleep patterns were assessed over three consecutive nights using actigraphy. Total sleep time (TST), sleep efficiency (SE), sleep latency onset (SL) and number of awakenings after sleep onset (WASO) were derived. Statistical analysis was conducted using unrelated t-tests and Pearson's product moment correlation co-efficients.
Results
CLBP participants demonstrated significantly poorer overall sleep both objectively and subjectively. They demonstrated lower actigraphic SE (p = .002) and increased WASO (p = .027) but no significant differences were found in TST (p = .43) or SL (p = .97). Subjectively, they reported increased insomnia (p =< .001), lower SE (p =< .001) and increased SL (p =< .001) but no difference between TST (p = .827) and WASO (p = .055). Statistically significant associations were found between low back pain (p = .021, r = -.589), physical health (p = .003, r = -.713), disability levels (p = .025, r = .576), and subjective sleep quality in the CLBP participants but not with actigraphy.
Conclusion
CLBP participants demonstrated poorer overall sleep, increased insomnia symptoms and less efficient sleep. Further investigation using a larger sample size and a longer period of sleep monitoring is ongoing.
doi:10.1186/1471-2474-10-122
PMCID: PMC2765952  PMID: 19799778

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