Is NCT07136415 recruiting in Novi, MI?

Yes, NCT07136415 is currently recruiting participants at its Novi, MI location. This menopausal women clinical trial is actively enrolling qualified participants.

How do I join the menopausal women clinical trial in Novi?

To join this clinical trial in Novi, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Novi clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Menopausal Women Clinical Trial in Novi, MI

About This Menopausal Women Study in Novi

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: 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.

Sponsor: Brigham and Women's Hospital

Who Can Participate

Inclusion 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., 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 Criteria

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Novi?

Yes, this clinical trial (NCT07136415) has an active research site in Novi, MI that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Menopausal Women Treatment Options in Novi, MI

If you're searching for menopausal women treatment options in Novi, MI, this clinical trial (NCT07136415) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Novi research site is actively enrolling participants for this clinical trial. You'll receive care from experienced menopausal women specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all menopausal women clinical trials near you to find additional studies recruiting in your area.

Menopausal Women Clinical Trial in Novi, MI

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