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 range
40 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)