NCT07136415 Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms
| NCT ID | NCT07136415 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Brigham and Women's Hospital |
| Condition | Menopausal Women |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2026-02-13 |
| Primary Completion | 2031-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,000 participants in total. It began in 2026-02-13 with a primary completion date of 2031-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn how three current insomnia therapies (trazodone, daridorexant, cognitive behavioral therapy for insomnia) compare with each other in peri- and post-menopausal women. It will also learn about the safety of the treatments. The main questions it aims to answer are: Which commonly used insomnia therapies are most effective and safe for improving insomnia symptoms in peri- and post-menopausal people? How well do the treatments work for people from different backgrounds, who are at different stages of menopause, and who have different conditions common during menopause (e.g., sleep apnea, mood disturbance, etc.)? What medical problems do participants have when using these treatments? Participants will: Be asked to take trazodone every night, take daridorexant every night, or participate in an online behavioral program for insomnia, for a total of 12 months. Participate in a total of one in-person visit and 7 virtual visits (phone calls) over the 12 months. Wear (and keep) a Fitbit and fill out a daily sleep diary for at least 4 weeks over the 12 months. Fill out online surveys 4 times over the 12 months.
Eligibility Criteria
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
Contact & Investigator
Suzanne Bertisch, MD, MPH
PRINCIPAL INVESTIGATOR
Brigham and Women's Hospital
Frequently Asked Questions
Who can join the NCT07136415 clinical trial?
This trial is open to female participants only, aged 40 Years or older, up to 62 Years, studying Menopausal Women. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07136415 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07136415 currently recruiting?
Yes, NCT07136415 is actively recruiting participants. Contact the research team at shng1@mgh.harvard.edu for enrollment information.
Where is the NCT07136415 trial being conducted?
This trial is being conducted at Boston, United States, Novi, United States, Winston-Salem, United States, Pittsburgh, United States and 1 additional location.
Who is sponsoring the NCT07136415 clinical trial?
NCT07136415 is sponsored by Brigham and Women's Hospital. The principal investigator is Suzanne Bertisch, MD, MPH at Brigham and Women's Hospital. The trial plans to enroll 1,000 participants.