This study evaluated whether a daily dietary sleep supplement could improve sleep in women aged 40 to 65 who experience moderate sleep disturbances during menopause. Participants were randomly assigned to take either the supplement or a placebo for about three weeks. All study visits were conducted virtually. Sleep was assessed through daily diaries and weekly questionnaires measuring sleep quality, nighttime awakenings, daytime alertness, and mood. The study's goal was to compare changes between the supplement and placebo groups and to assess safety and tolerability during the study period.
This study was a randomized, double-blind, placebo-controlled, parallel-group clinical trial conducted to evaluate the effects of a dietary sleep supplement on subjective sleep disturbance, sleep-related impairment, and related sleep parameters in perimenopausal and postmenopausal women with moderate sleep complaints. Participants were enrolled remotely and randomized in a 1:1 ratio to receive either the investigational dietary supplement or a matching placebo. Randomization was performed using a blinded allocation scheme, and blinding was maintained for participants and all study personnel involved in participant management, data collection, and outcome assessment. Study products were physically and visuallyishable to preserve masking throughout the study. Following electronic informed consent, participants completed a screening phase conducted via virtual visit, during which baseline sleep disturbance and medical history were assessed to confirm eligibility. Eligible participants then entered a run-in period of approximately seven days, during which they completed daily electronic sleep diaries to establish baseline sleep patterns and to familiarize themselves with study procedures. No study product was consumed during the run-in period. After completion of the run-in phase, participants initiated the intervention period (Day 1) and self-administered the assigned study product once daily for 21 ± 3 days. The investigational product was administered orally approximately 60 minutes before bedtime, and participants randomized to placebo followed an identical dosing schedule. Throughout the intervention period, participants completed daily electronic sleep diaries and periodic electronic questionnaires assessing changes in sleep disturbance, sleep-related impairment, overall sleep quality, and daytime functioning. Assessments were collected at baseline and at regular intervals during the dosing period, consistent with the protocol-defined schedule of activities. At the end-of-study visit, participants completed a product experience questionnaire evaluating usability and overall experience with the study product. All study visits and assessments were conducted remotely. Safety and tolerability were monitored throughout the study through participant self-report and scheduled virtual check-ins. Adverse events were collected, assessed for severity and relatedness, and followed through resolution in accordance with protocol-defined safety monitoring procedures. Each participant's total duration of participation was approximately four to five weeks, including screening, run-in, intervention, and end-of-study assessments. The study was designed to characterize the short-term effects, safety, and tolerability of a dietary sleep supplement in menopausal women experiencing moderate sleep disturbance under fully remote study conditions.
A daily dietary sleep supplement taken once per day for 21 days.
A placebo matched in appearance and dosing schedule to the sleep supplement, taken once per day for 21 days.
Bonafide Health, LLC
Harrison, New York, United States
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep Disturbance Short Form 8b T-score
Change from baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep Disturbance Short Form 8b T-score, a validated patient-reported outcome measure assessing perceived sleep quality, difficulty falling or staying asleep, and overall sleep satisfaction over the prior 7 days. The PROMIS Sleep Disturbance Short Form 8b yields raw scores ranging from 8 to 40, which are converted to standardized T-scores ranging from 28.9 to 76.5. Higher T-scores indicate greater sleep disturbance (worse sleep outcomes).
Time frame: Day -7 (run-in baseline) to Day 21 (±3 days)
Responder Rate for Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep Disturbance Short Form 8b
Responder rate defined as the proportion of participants achieving a clinically meaningful improvement in sleep disturbance, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep Disturbance Short Form 8b T-score. The PROMIS Sleep Disturbance Short Form 8b yields raw scores ranging from 8 to 40, corresponding to standardized T-scores ranging from 28.9 to 76.5, with higher scores indicating greater sleep disturbance (worse sleep outcomes). Responders were defined as participants who experienced a decrease of ≥8 points in the PROMIS Sleep Disturbance T-score from baseline, consistent with the established minimal clinically important difference (MCID) for this measure.
Time frame: Day -7 (run-in baseline) to Day 21 (±3 days)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep-Related Impairment Short Form 8a T-score
Change from baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep-Related Impairment Short Form 8a T-score, a validated patient-reported outcome measure assessing daytime alertness, sleepiness, fatigue, and functional impairment related to sleep over the prior 7 days. The PROMIS Sleep-Related Impairment Short Form 8a yields raw scores ranging from 8 to 40, which are converted to standardized T-scores ranging from 30.0 to 80.1. Higher T-scores indicate greater sleep-related impairment (worse daytime functioning).
Time frame: Day -7 (run-in baseline) to Day 21 (±3 days)
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
128
Responder Rate for Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep-Related Impairment Short Form 8a
Responder rate defined as the proportion of participants achieving a clinically meaningful improvement in sleep-related impairment, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep-Related Impairment Short Form 8a T-score. The PROMIS Sleep-Related Impairment Short Form 8a yields raw scores ranging from 8 to 40, corresponding to standardized T-scores ranging from 30.0 to 80.1, with higher scores indicating greater sleep-related impairment (worse daytime functioning). Responders were defined as participants who experienced a decrease of ≥6.5 points in the PROMIS Sleep-Related Impairment T-score from baseline, based on the 95% reliable change index (RCI), representing a magnitude of change exceeding measurement error and consistent with clinically meaningful improvement in similarly aged adults with sleep-related impairment.
Time frame: Day -7 (run-in baseline) to Day 21 (±3 days)
Change in Sleep Quality as Measured by a Visual Analog Scale (VAS)
Change from baseline in self-reported sleep quality measured using a visual analog scale (VAS) ranging from 0 to 100, where lower scores indicate better sleep quality and higher scores indicate poorer sleep quality or satisfaction. Improvement in sleep quality is reflected by a decrease in VAS score from baseline.
Time frame: Day -7 (run-in baseline) to Day 21 (±3 days)
Change in Total Sleep Time (TST)
Change from baseline in total nightly sleep duration, measured in minutes, as recorded in daily morning sleep diaries. Higher values indicate longer total sleep time, with increases from baseline reflecting improvement in sleep duration.
Time frame: Day -7 (run-in baseline) to Day 21 (±3 days)
Change in Sleep Efficiency
Change in sleep efficiency calculated from daily diary entries as the ratio of total sleep time to time in bed.
Time frame: Day -7 (run-in baseline) to Day 21 (±3 days)
Change in Sleep-Onset Latency (SOL)
Change from baseline in sleep-onset latency, measured in minutes, defined as the time required to fall asleep after attempting to sleep, as recorded in daily morning sleep diaries. Lower values indicate shorter sleep-onset latency, with decreases from baseline reflecting improvement in sleep initiation.
Time frame: Day -7 to Day 21 (±3 days)
Change in Difficulty Falling Asleep as Measured by a Visual Analog Scale (VAS)
Change from baseline in self-reported difficulty falling asleep measured using a visual analog scale (VAS) ranging from 0 to 100, where lower scores indicate less difficulty falling asleep and higher scores indicate greater difficulty. Improvement is reflected by a decrease in VAS score from baseline.
Time frame: Day -7 (run-in baseline) to Day 21 (±3 days)
Change in Wake After Sleep Onset (WASO)
Change from baseline in wake after sleep onset (WASO), measured in minutes, defined as the total time spent awake after initially falling asleep, as recorded in daily morning sleep diaries. Lower values indicate less wake time after sleep onset, with decreases from baseline reflecting improvement in sleep maintenance.
Time frame: Day -7 to Day 21 (±3 days)
Change in Number of Spontaneous Nighttime Awakenings
Change from baseline in the number of spontaneous nighttime awakenings, measured as a count per night, as recorded in daily morning sleep diaries. Lower values indicate fewer awakenings, with decreases from baseline reflecting improvement in sleep continuity.
Time frame: Day -7 (run-in baseline) to Day 21 (±3 days)
Change in Sleep Disturbance as Measured by a Visual Analog Scale (VAS)
Change from baseline in self-reported sleep disturbance measured using a visual analog scale (VAS) ranging from 0 to 100, where lower scores indicate less perceived sleep disturbance and higher scores indicate greater disturbance. Improvement is reflected by a decrease in VAS score from baseline.
Time frame: Day -7 (run-in baseline) to Day 21 (±3 days)
Change in Number of Nocturia Episodes
Change from baseline in the number of nocturia episodes per night, measured as a count, defined as the number of times a participant awakened to use the restroom during the night, as recorded in daily morning sleep diaries. Lower values indicate fewer nocturnal bathroom visits, with decreases from baseline reflecting improvement in sleep maintenance.
Time frame: Day -7 (run-in baseline) to Day 21 (±3 days)