A Study of a Sleep Supplement to Improve Sleep in Women Going Through Menopause
A Study of a Sleep Supplement to Improve Sleep in Women Going Through Menopause
NCT ID: NCT07375095 Phase: NA Status: COMPLETED Enrollment: 128 Completion: 2024-04-07
Conditions
Sleep Disturbance
Interventions
Sleep Supplement, Placebo
Summary
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.
Primary Outcome
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep Disturbance Short Form 8b T-score