Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms (NCT07136415) | Clinical Trial Compass
RecruitingPhase 4
Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms
United States1,000 participantsStarted 2026-02-13
Plain-language 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.
Who can participate
Age range40 Years – 62 Years
SexFEMALE
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:
* 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 d…