Understanding how menopause affects women's sleep
ESTeeM: Evaluation of Sleep Disturbances in Menopause
This study looks at how menopause affects sleep in women who have hot flashes to better understand their sleep problems and overall health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 40 Years to 65 Years |
| Sex | Female |
| Sponsor | Bayer Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Whippany, New Jersey) |
| Trial ID | NCT06728332 on ClinicalTrials.gov |
What this trial studies
This observational study collects data from women experiencing sleep disturbances related to menopause, specifically those with vasomotor symptoms like hot flashes. Participants will continue their standard treatments for sleep disturbances while researchers gather information on how these issues impact their overall health and well-being. The study aims to enhance understanding of menopause-related sleep problems and current treatment approaches, addressing a gap in knowledge for both patients and healthcare providers.
Who should consider this trial
Good fit: Ideal candidates are women aged 40-65 who are experiencing menopause and have self-reported sleep disturbances.
Not a fit: Patients whose menopause is chemically induced or who have medical conditions affecting sleep may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for sleep disturbances in menopausal women.
How similar studies have performed: While there is limited data on similar observational studies, the approach of understanding menopause's impact on sleep is increasingly recognized as important.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women experiencing menopause assigned female at birth, 40-65 years of age, residing in the United States. o Where being in the menopausal period is defined as at least 12 months of spontaneous amenorrhea prior to index date (the date informed consent was signed) or surgical bilateral oophorectomy with or without hysterectomy at least 6 weeks prior to index date. * Sleep disturbances due to menopause, defined as self-reported disturbances characterized by waking up at night and/or poor quality of sleep (including difficulty falling asleep, short sleep, waking up early). * Signed ICF by the patient. * Provided access to medical records, directly granting access through the HRS platform and the provider's portal or providing contact information and a medical records release form. Exclusion Criteria: * Menopause induced chemically or from radiation therapy (i.e., chemotherapy). * Medical conditions that impact sleep, including diagnosed chronic insomnia, sleep apnea, restless leg syndrome, circadian rhythm sleep disorder; current or history (except complete remission for 5 years or more) of any malignancy (except basal and squamous cell skin tumors). * Women self-reporting being under the care of a HCP for suicidal ideation in the past six months, clinical anxiety in the past six months, or clinical depression in the past six months. * Patients participating in a clinical trial. * Pregnant women.
Where this trial is running
Whippany, New Jersey
- Bayer — Whippany, New Jersey, United States (Recruiting)
Study contacts
- Study coordinator: Bayer Clinical Trials Contact
- Email: clinical-trials-contact@bayer.com
- Phone: (+)1-888-84 22937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.