A Study of a Sleep Supplement to Improve Sleep in Women Going Through Menopause (NCT07375095) | Clinical Trial Compass
CompletedNot Applicable
A Study of a Sleep Supplement to Improve Sleep in Women Going Through Menopause
United States128 participantsStarted 2023-10-10
Plain-language 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.
Who can participate
Age range40 Years – 65 Years
SexFEMALE
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Inclusion criteria
✓. Healthy women who are 40 to 65 years of age (inclusive).
✓. Have a body mass index (BMI) between 18.5 to 34.9 kg/m2 (inclusive).
✓. PROMIS SD SF T-Score Cut Point ≥ 60 (equivalent to a raw score of 30).
✓. Women enrolled in this research study may be of perimenopausal, (12 or more months without a menstrual period) or post-menopausal status.
✓. Post-menopause defined as the last natural menstrual period (LNMP) completed at least 12 months prior to screening.
✓. Perimenopause defined as women who complained of irregular menstrual cycle in the past 12 months, with a forward or postponed cycle more than 7 days.
✓. In good general health (no active or uncontrolled diseases or conditions) and able to consume the study product.
✓. Agree to refrain from treatments listed in Section 12.4 in the defined timeframe.
Exclusion criteria
✕
What they're measuring
1
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep Disturbance Short Form 8b T-score
Timeframe: Day -7 (run-in baseline) to Day 21 (±3 days)
2
Responder Rate for Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep Disturbance Short Form 8b
Timeframe: Day -7 (run-in baseline) to Day 21 (±3 days)
3
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep-Related Impairment Short Form 8a T-score
Timeframe: Day -7 (run-in baseline) to Day 21 (±3 days)
4
Responder Rate for Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep-Related Impairment Short Form 8a
Timeframe: Day -7 (run-in baseline) to Day 21 (±3 days)