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Compares treatment options for Menopausal Women
Official title Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms
ClinicalTrials.gov ID: NCT07136415
What this study is testing
What is Trazodone?
Trazodone is an investigational medicine, given as an once-daily, being studied as a potential treatment for menopausal women.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 62, women only
You may be able to join if
- 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...
- Insomnia severity index score \> 10 at screening
- Insomnia started or worsened during peri- or early menopause
You likely can't join if
- 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 how well it works of the interventions (e.g., night shift workers with \>1 night shift/week; main sleep...
- Regular use of hypnotics \> 2 nights/week
- Limited internet access
See the full eligibility 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...
- 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)
- 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 how well it works 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...
- 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...
- Use of one of the interventions in the past 6 months
- Other conditions determined by the PI or study clinician to preclude study participation
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Novi, Michigan, United States
- Winston-Salem, North Carolina, United States
- Pittsburgh, Pennsylvania, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 40 years to 62 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Novi, Michigan, United States; Winston-Salem, North Carolina, United States; Pittsburgh, Pennsylvania, United States; Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.