Which sleep therapy works best for menopausal women? major study aims to find out
NCT ID NCT07136415
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares three common insomnia treatments—two medications (trazodone and daridorexant) and an online behavioral therapy program—in 1,000 women aged 40-62 who are in or near menopause. Participants will take one treatment for 12 months, wear a Fitbit, and complete sleep diaries and surveys. The goal is to see which therapy improves sleep most effectively and safely, and how well they work for women of different backgrounds and stages of menopause.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 1,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Feb 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 62 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 40-62 years * Assigned female sex at birth * In peri- or early menopause, following the STRAW criteria of self-report of irregular menstrual cycle or within 5 years from the last menstrual period. When menstrual markers are absent or unreliable (e.g., hysterectomy; endometrial ablation), participants must be older than 45 years old and report hot flashes * Insomnia severity index score \> 10 at screening * Insomnia started or worsened during peri- or early menopause * English or Spanish speaking (Spanish-only speaking individuals will be recruited after full development of Spanish-facing materials, which may lag initial study start) Exclusion Criteria: * Untreated, previously diagnosed severe sleep apnea (self-report; chart review; clinician assessment) * Untreated, previously diagnosed moderate-severe restless legs syndrome (self-report; chart review) * Severe daytime sleepiness (Epworth Sleepiness Scale \> 15) at screening * Sleep schedule issues that would impact effectiveness of the interventions (e.g., night shift workers with \>1 night shift/week; main sleep period outside of 8pm - 11am) * Regular use of hypnotics \> 2 nights/week * Limited internet access * Pregnant or lactating or positive urine pregnancy test at baseline visit * Prolonged QTc interval (\>460 ms) (by study baseline electrocardiogram (EKG) or EKG report in medical record) * History of the following health conditions: Uncontrolled hypertension; clinically significant heart disease such as arrhythmias requiring medication, cardiomyopathies, heart failure, clinically significant valvular heart disease, or severe coronary artery disease (unstable angina, myocardial infarction in the prior 6 months); hypersomnia or narcolepsy; bipolar disorder, severe depression, or psychosis ; seizure within the past year; use of opioids or substance use disorder; known allergy or contraindication to trazodone or daridorexant (self-report and chart review); known severe chronic liver disease (e.g. cirrhosis); end-stage renal disease on hemodialysis; other severe medical comorbidity (e.g. likely hospitalization within next 6 months or medical conditions that increase risk of participation at a study clinician's discretion) * Use of medications such as those that: Have known potential for significantly prolonging the QT interval (i.e. antiarrhythmics such as amiodarone, sotalol, quinidine, procainamide, dofetilide, and ibutilide), are strong CYP3A4 inhibitors, or are moderate or strong CYP3A4 inducers * Use of one of the interventions in the past 6 months * Other conditions determined by the PI or study clinician to preclude study participation
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Atrium Health Wake Forest Baptist
NOT_YET_RECRUITINGWinston-Salem, North Carolina, 27103, United States
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Brigham and Women's Hospital
RECRUITINGBoston, Massachusetts, 02120, United States
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Henry Ford Medical Center
RECRUITINGNovi, Michigan, 48377, United States
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University of Pittsburgh Medical Center
RECRUITINGPittsburgh, Pennsylvania, 15213, United States
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University of Utah
RECRUITINGSalt Lake City, Utah, 84108, United States
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Other studies related to the condition(s) this trial covers.
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