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Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms

Study acronym: CELESTE
StatusRecruiting
PhasePhase 4
Started2026-02-13
View on ClinicalTrials.gov ↗

Amendment history

2026-06-05
Study Status, Contacts/Locations v4
Study sitesdetails revised at 3 of 5 sites
2026-03-13
Not Yet Recruiting→Recruiting Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2026-02→confirmed 2026-02-13
Study sites1→5
Eligibility criteria+385 characters
Inclusion Criteria: Age 40-62 years Assigned female sex at birth In peri- or early menopause, following the STRAW criteria of [...] ual cycle or within 5 years from the last menstrual period. In the absence of a reliableWhen menstrual markermarkers are absent or unreliable (e.g., hysterectomy; endometrial ablation), participants mu [...] ld 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 [...] [...]
Secondary endpoints17 to 19 entries
Insomnia Severity Index PROMIS Pain Interference
Study description+32 characters
[...] it: Fill out surveys. At 6-months, weight will be measured. TheDuring 7the daysvisit after these visitswindow, the participant will also be asked to wear their Fitbit fo [...] every day and fill in a sleep diary in the morning and night for a total of 7 days. 9-Months Call: Quick phone call with study staff to see if [...] ere are any issues. 12-Months Call/Visit: Fill out surveys. TheDuring 7the daysvisit after these visitswindow, the participant will also be asked to wear their Fitbit fo [...] every day and fill in a sleep diary in the morning and night for a total of 7 days. The Fitbit is for the participant to [...]
2025-12-30
Study Status v2
Primary completion date2030-01-01→2031-02
Completion date2030-01-01→2031-02
Start date2025-12-01→2026-02
2025-11-19
Study Status, Study Description, Eligibility v1
Eligibility criteria+678 characters
[...] rine pregnancy test at baseline visit Prolonged QTc interval (>460 ms) (by study baseline electrocardiogram (EKG) or most recent EKG report in medical record) Excessive riskHistory of interventionsuncontrolled 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 antiarrh [...] (e.g., known heart disease, history cirrhosis) History of hypersomnia, narcolepsy, bipolar disorder or [...] [...]
Study description+40 characters
Insomnia, or trouble sleeping, is acommon. It common condition experienced byaffects about 1 in 10 adults. Insomnia is characterized by unhappinessPeople with sleepinsomnia qualityare not happy with how long or durationhow well they sleep. Insomnia has been linked withto a higher risk of depression, heart disease, memory problems, and cognitive decline, lower quality of life,. It andcan contributesalso lead to missing work and having accidents. Sleep disturbances,problems such aslike insomnia, are also common complaintsor forpeople individualsgoing inthrough the peri-perimenopause and post-men [...] [...]
2025-08-14
Original filing
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.
Trial Details
NCT Number NCT07136415
Lead Sponsor Brigham and Women's Hospital
Collaborators: Patient-Centered Outcomes Research Institute, University of Pittsburgh, University of Utah, Massachusetts General Hospital, Henry Ford Health System, Wake Forest University Health Sciences
Conditions Menopausal Women, Insomnia
Enrollment 1,000 participants
Start Date 2026-02-13
Primary Completion 2031-02 (estimated)
Study Completion 2031-02 (estimated)
Updated on ClinicalTrials.gov 2026-06-08