Status:
NOT_YET_RECRUITING
Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
University of Pittsburgh
Conditions:
Menopausal Women
Insomnia
Eligibility:
FEMALE
40-62 years
Phase:
PHASE4
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-menopaus...
Detailed Description
Insomnia, or trouble sleeping, is common. It affects about 1 in 10 adults. People with insomnia are not happy with how long or how well they sleep. Insomnia has been linked to a higher risk of depress...
Eligibility Criteria
Inclusion
- 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. In the absence of a reliable menstrual marker (e.g., hysterectomy; endometrial ablation), participants must be older than 45 years old and report hot flashes
- Insomnia severity index score \> 10
- Insomnia started or worsened during peri- or early menopause
- English-speaking
Exclusion
- Untreated, previously diagnosed severe sleep apnea (self-report; chart review)
- Untreated, previously diagnosed moderate-severe restless legs syndrome (self-report; chart review)
- Severe daytime sleepiness (Epworth Sleepiness Scale \> 15)
- Likelihood of limited benefit (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
- Positive urine pregnancy test at baseline visit
- Prolonged QTc interval (\>460 ms) (by study baseline electrocardiogram (EKG) or most recent EKG report in medical record)
- History of uncontrolled hypertension or 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)
- Use of antiarrhythmics that prolong QTc interval severely (i.e. amiodarone, sotalol, quinidine, procainamide, dofetilide, and ibutilide).
- Known severe chronic liver disease (e.g. cirrhosis)
- History of hypersomnia, narcolepsy, bipolar disorder or psychosis, severe depression, seizure within the past year, use of opioids/substance abuse disorder, pregnant or lactating, , use of strong CYP3A4 inhibitors , use of moderate or strong CYP3A4 inducers, end-stage renal disease on hemodialysis, known allergy to trazodone or daridorexant (self-report and chart review) or other medical condition that increases risk of participation at a study physician's discretion.
- Use of one of the interventions in the past 6 months
- Severe medical comorbidity (e.g., End Stage Renal Disease, likely hospitalization within next 6 months)
- Other conditions determined by the PI to preclude study participation
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2031
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT07136415
Start Date
February 1 2026
End Date
February 1 2031
Last Update
December 31 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120