Menopausal Women study: Trazodone vs Daridorexant
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 medication being studied to see if it helps with sleep problems in menopausal women. It is designed to affect chemicals in the brain that help control sleep and mood.
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 study aims to find out which of three common sleep treatments works best and is safest for women with insomnia during menopause. It also looks at how well these treatments work for women with different health conditions.
- Who it's for
- The study is looking for women who are going through menopause or have already gone through it and have trouble sleeping.
- What's involved
- Participants will use one of three treatments: a medication called trazodone, a medication called daridorexant, or an online sleep program. They will wear a Fitbit, keep a daily sleep diary, and complete online surveys.
- Time commitment
- The study lasts 12 months and requires one in-person visit and seven phone calls.
- 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
- 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.
- 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.
- 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 is enrolling
- Boston, Massachusetts, United States
- Novi, Michigan, 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, but 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?
This study is enrolling now at Boston, Massachusetts, United States; Novi, Michigan, United States; Pittsburgh, Pennsylvania, United States; Salt Lake City, Utah, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.