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

This study is comparing three ways to treat insomnia (trouble sleeping) in women aged 40-62 who are going through perimenopause or menopause. You could receive a digital therapy called SHUT-i (a type of cognitive behavioral therapy for insomnia, or CBT-i), or one of two medications: Trazodone or Daridorexant. Researchers want to see which of these treatments is most effective and safe for improving sleep, and how well they work for women with different backgrounds and health conditions. The main goal is to measure your sleep disturbance after 6 months of treatment. This study is currently recruiting about 1000 participants.

Study design: This interventional study is comparing three different treatments for insomnia. It plans to enroll 1000 participants.
What's involved: You would participate in the study for about 12 months. This includes a consent call, a screening visit with surveys, a pregnancy test, an EKG, and height/weight measurement, and then receiving one of the three therapies.
Compensation: Not stated in the trial record.
Follow-up: Your sleep disturbance will be measured at 6 months after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting

PHASE4Ages 40–62InterventionalTreatment

Brigham and Women's Hospital

~1,000 participants

Updated 2026-06-08 on ClinicalTrials.gov

What's tested:Cognitive behavioral therapy for insomnia (CBT-i)TrazodoneDaridorexant

At a glance

Recruiting sites

4 of 5 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

PROMIS Sleep Disturbance T-score

Measured over 6 Months

Conditions

Menopausal Women

Insomnia

Where it's being run

5 sites across 5 states

Massachusetts1

Michigan1

North Carolina1

Pennsylvania1

Utah1

Study leadership

Suzanne Bertisch, MD, MPH · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital

Who to contact

Sharon Ng, MS

[email protected]

617-525-7097

Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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

What this trial measures

PROMIS Sleep Disturbance T-score6 Months
The primary outcome is PROMIS sleep disturbance, which fulfills the criteria for content validity of a patient-reported outcome with reported relevance, comprehensiveness, ease of use, and treatment responses among people with menopause-related insomnia from diverse geographic locations. Sleep disturbance is one of the most bothersome symptoms of the menopause transition and one of the top reasons health care providers report women seek care. The PROMIS sleep disturbance scale will be used and the possible range of raw score is 8-40. A higher score means higher levels of sleep disturbance. Item responses are combined to yield a T-score with a population mean of 50 and standard deviation of 10.

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