Actively Recruiting
CELESTE: Comparative Effectiveness Study of Behavioral and Drug-Related Insomnia Therapies for Peri- and Post-menopausal People
Led by Brigham and Women's Hospital · Updated on 2026-06-08
1000
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
Sponsors
B
Brigham and Women's Hospital
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how three common treatments for insomnia—trazodone, daridorexant, and cognitive behavioral therapy for insomnia (CBT-I)—compare in effectiveness and safety for peri- and post-menopausal women. The study aims to understand which therapies work best for improving insomnia symptoms and how they affect people with varying backgrounds, menopause stages, and related health conditions such as sleep apnea and mood disturbances. Participants will be randomly assigned to one of three groups: an online CBT-I program lasting 6-9 weeks with ongoing access for 12 months, nightly oral trazodone with dose adjustments over 12 months, or nightly oral daridorexant for 12 months with safety monitoring. Both medications are FDA-approved for related uses, and the study will monitor treatment safety and adherence throughout. Participants will attend one in-person visit and seven virtual visits during the 12-month study. They will complete surveys, wear a Fitbit to track sleep, and keep a daily sleep diary at various times. Safety and side effects will be monitored through phone calls, and at certain visits, weight and other assessments will be conducted. The main measure of success is the PROMIS Sleep Disturbance T-score at 6 months.
CONDITIONS
Brief Title
Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40 to 62 years
- Assigned female sex at birth
- In peri- or early menopause based on self-reported menstrual changes or within 5 years of last menstrual period
- If menstrual markers are absent, older than 45 years with hot flashes
- Insomnia Severity Index score greater than 10 at screening
- Insomnia started or worsened during peri- or early menopause
- English or Spanish speaking
You will not qualify if you...
- Untreated severe sleep apnea
- Untreated moderate to severe restless legs syndrome
- Severe daytime sleepiness (Epworth Sleepiness Scale over 15)
- Sleep schedule issues affecting treatment (e.g., working more than 1 night shift per week, main sleep outside 8pm-11am)
- Regular use of hypnotics more than 2 nights per week
- Limited internet access
- Pregnant, lactating, or positive pregnancy test
- Prolonged QTc interval over 460 ms
- History of uncontrolled hypertension, significant heart disease, hypersomnia, narcolepsy, bipolar disorder, severe depression, psychosis, recent seizures, opioid use, substance use disorder
- Allergy or contraindication to trazodone or daridorexant
- Severe chronic liver disease, end-stage renal disease on hemodialysis
- Use of medications that affect QT interval or CYP3A4 metabolism
- Use of study interventions in past 6 months
- Other conditions deemed exclusionary by study clinician or principal investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive one of three insomnia therapies: a behavioral therapy program called CBT-I over 6-9 weeks, or daily medication with trazodone or daridorexant for up to 12 months. Study staff will monitor and adjust medication doses as needed during the first month.
Phone calls at 1 week and 4 weeks; calls or visits at 3 months, 6 months, 9 months, and 12 months
Duration - Throughout the 12-month study duration
During treatment and follow-up visits, participants will complete surveys, have weight measured, and wear a Fitbit and fill out sleep diaries for 7 days at certain timepoints to monitor sleep patterns and quality.
Visits or calls at 3 months, 6 months, 9 months, and 12 months with Fitbit wear and diary completion at 6 and 12 months
Trial Site Locations
Total: 5 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120
Actively Recruiting
2
Henry Ford Medical Center
Novi, Michigan, United States, 48377
Actively Recruiting
3
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States, 27103
Not Yet Recruiting
4
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
5
University of Utah
Salt Lake City, Utah, United States, 84108
Actively Recruiting
Research Team
S
Sharon Ng, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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