A total of 4,279 people were screened for the study. Seventy people met all eligibility criteria, volunteered and enrolled in the study. But 5 participants who started the study were administratively withdrawn due to early protocol violations making them ineligible for study participation (e.g., beginning medication on the exclusion list, an undisclosed health problem on the exclusion list). Three subjects opted out of the study (e.g., schedule conflicts, catching the flu) prior to treatment allocation and 3 subjects were not within the targeted age range for the present study, leaving a total of 59 participants who received the homeopathic treatment and completed the study. Five subjects from the remaining 59 enrolled participants did not meet the criterion for the minimum 4 hours of sleep per night and/or did not have enough data on their baseline recordings for analysis. The results reported reflect the findings from the remaining 54 participants, (allocated to Coffea Cruda [n=26] or Nux Vomica [n=28] on night 22).
In-home recordings pose unique challenges for data quality. Portions of different nights and unavailability for some subjects on certain nights contributed to difficulties obtaining complete data. Individual electrodes or, rarely, the main battery pack cables detached during the sleep period on various nights in different subjects, resulting in partial data loss. On average, out of the 4 possible baseline nights (nights 1, 2, 15, 16) subjects contributed 2.96 ± 1.00 baseline nights. There were two possible nights of data on both placebo and remedy weeks. Subjects on average contributed 1.39 ± 0.74 and 1.33 ± 0.67 days respectively, on placebo and remedy week. Outcome data on missing nights (due to the absence of data or failure to meet the sleep quality standard) were imputed as follows: any values that had valid data on any preceding or following night in the study design were determined by linear interpolation. Then, any remaining missing values were filled in by carrying the last value forward.
The final sample of young adults (N=54) in the current report had a mean age of 20 SD 2 years (50% female). shows that the subsets of subjects who received Coffea Cruda (n=26) versus Nux Vomica (n=28) did not differ in age, gender distribution, CMASI, PSQI, baseline PSG and sleep diary parameters.
gives the verum effects in comparison with placebo and significance levels for the effects of the remedies together and separately. These effects are reported using unstandardized coefficients with standard errors to interpret the variables in their unit of measurement. When data from the two remedies were combined, overall PSG for the remedy week showed significantly longer TST, increased NREM sleep including more minutes in stage 2 and increased slow wave sleep (SWS), with a trend toward increased minutes of stage 4 sleep (β=5.8, p<0.10) compared with placebo. Remedies also led to more sleep disruptions after sleep onset, with significantly increased awakenings, number of stage changes, and more type 2 arousals compared to placebo.
Table 2 Regression Findings for Within-Subject Analyses on means for combined remedy nights (22/23) versus means for combined placebo nights 8/9, controlling for gender, personality scores, total time in bed, and means for combined baseline nights (1/2/15/16) (more ...)
In the remedy-specific within-subject analyses, Coffea Cruda and Nux Vomica recipients both showed similar significant effects of increasing TST and NREM on verum as compared with placebo nights. But only Nux Vomica effects were significant for increases in type 2 arousals and on the Arousal Index on verum versus placebo nights.
Differences between Nux Vomica and Coffea Cruda treatment groups for remedy week nights 22 and 23 were compared. The only variable with a significant difference was a lower arousal index for the Coffea Cruda recipients (β= −1.24, 95% confidence interval −2.5 to −0.01, t=−2.1, p=0.049). Nux Vomica and Coffea Cruda recipients did not significantly differ on the remaining variables listed in .
Within-subject analyses of the actigraphic measures, which depend on indications of gross motor activity of the wrist rather than EEG, showed no significant treatment effects on TST, sleep onset latency, sleep efficiency, or fragmentation index.
For the subjective measures, individuals receiving Coffea Cruda showed a trend toward a decrease in POMS fatigue on the post-verum night compared with the post-placebo night (). Overall, remedy (verum) week was not different from placebo week on the subjective ratings of global sleep quality on the weekly PSQI, after controlling for baseline values. On the daily morning sleep diary ratings (3 possible categories: fatigued, somewhat refreshed, refreshed), the only finding was a trend toward poorer subjective sleep for Nux Vomica compared with placebo in a logistic regression, controlling for personality and sex (OR 0.29, CI 0.08–1.11, p=0.07).