Résztvevőt keres itt: Egyesült Államok4. fázis

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

A legfontosabb adatok

Ki végzi: Brigham and Women's Hospital
Hol: Boston, Novi, Pittsburgh, Salt Lake City és Winston-Salem (Egyesült Államok)Mind a 5 helyszín megnézése
Azonosító: NCT07136415
Állapot: Toboroz
Fázis: 4. fázis
Résztvevők: 1000 fő, tervezett
Kezdés: 2026. febr. 13.
Várható befejezés: 2031. febr.
A vizsgálat típusa: Beavatkozással járó, 3 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
A vizsgált kezelések: Cognitive behavioral therapy for insomnia (CBT-i)
Trazodone
Daridorexant
A regiszteradat frissítve: 2026. június 8.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for women in peri- or early menopause whose insomnia started or got worse during menopause. It compares trazodone, daridorexant and an online behavioral program (CBT-i).

Életkor: 40 to 62 years. If menstrual signs cannot be used (for example after hysterectomy), people must be older than 45 years and have hot flashes.
Nem: People assigned female sex at birth.
A betegség stádiuma: Peri- or early menopause: irregular periods or within 5 years of the last period. Insomnia severity index score > 10 at screening. Insomnia started or worsened during peri- or early menopause.
Korábbi kezelés: Cannot join if they used trazodone, daridorexant or CBT-i in the past 6 months. Cannot join if they use sleeping pills more than 2 nights/week.
Biomarker vagy leletérték: Heart test (EKG) must not show a QTc interval > 460 ms.

A részvétel fő kizáró okai

Untreated severe sleep apnea or untreated moderate-severe restless legs syndrome
Severe daytime sleepiness (Epworth Sleepiness Scale > 15), night shift work more than 1 night/week, or main sleep outside 8pm - 11am
Pregnant, breastfeeding, or positive urine pregnancy test
Serious heart disease, uncontrolled high blood pressure, bipolar disorder, severe depression, psychosis, seizure in the past year, or opioid or substance use
Limited internet access, or use of certain medicines that affect heart rhythm or CYP3A4

A regiszter feltételei, szó szerint

Mind a 18 feltétel megnézéseKevesebb

Ki vehet részt

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)

Ki nem vehet részt

Untreated, previously diagnosed severe sleep apnea (self-report; chart review; clinician assessment)
Untreated, previously diagnosed moderate-severe restless legs syndrome (self-report; chart review)
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)
Other conditions determined by the PI or study clinician to preclude study participation
Prolonged QTc interval (>460 ms) (by study baseline electrocardiogram (EKG) or EKG report in medical record)
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
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
Use of one of the interventions in the past 6 months

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

40 és 62 év között vagy?

Helyszínek itt: Egyesült Államok

Brigham and Women's HospitalBoston, Egyesült ÁllamokContact: Sharon Ng, MSRésztvevőt keres
Henry Ford Medical CenterNovi, Egyesült ÁllamokContact: Heba AfanehRésztvevőt keres
University of Pittsburgh Medical CenterPittsburgh, Egyesült ÁllamokContact: Molly HundertmarkRésztvevőt keres
University of UtahSalt Lake City, Egyesült ÁllamokContact: Alesia BoothRésztvevőt keres
Atrium Health Wake Forest BaptistWinston-Salem, Egyesült ÁllamokContact: Hanna NoughaniToborzás még nem indult

A vizsgálatról

Mit akar kideríteni a vizsgálat

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:

A teljes eredeti leírásKevesebb

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.

A vizsgálat 3 csoportja

Cognitive behavioral therapy for insomnia (CBT-i)Már használt kezelés, összehasonlításként
Participants will be asked to take part in the CBT-i program over the course of 6-9 weeks, with the option of revisiting content throughout the study duration (12 months).
TrazodoneMár használt kezelés, összehasonlításként
Participants will be asked to take trazodone (oral pill administration) for the duration of the study (12 months), with safety monitoring conducted by study staff throughout the study. Dosage adjustments may occur.
DaridorexantMár használt kezelés, összehasonlításként
Participants will be asked to take daridorexant (oral pill administration) for the duration of the study (12 months), with safety monitoring conducted by study staff throughout the study.