NCT06728332

An Observational Study to Learn More About How Menopause Affects Women's Sleep and How They Are Being Treated for Sleep Problems

ESTeeM: Evaluation of Sleep Disturbances in Menopause

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 750 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is an observational study in which data from women with sleep disturbances and vasomotor symptoms, also known as hot flashes, associated with menopause (SDM) are collected and studied. Menopause is part of a natural aging process and happens when women's menstrual cycles, also called periods, stop. Sleep disturbances, such as frequent waking up at night, are a common symptom (clinical sign) and a major worry associated with menopause that affects women's quality of life. The participants will continue to take their regular treatment for their SDM as agreed with their doctors. These are called "standard of care" treatments. Because both patients and doctors don't know much about SDM, women are often treated with sleep medicines that can lead to addiction and cause side effects. This study will help us to learn more about how much menopause-related sleep problems affect a woman's overall health and well-being. We also want to find out how women are currently being treated or treat themselves for these sleep problems, so we can figure out if there's a need for new treatments that focus specifically on menopause-related sleep issues To do this, researchers will collect information on: * the number of times a woman wakes up during the night and the total time she is awake after she first falls asleep * the time when a woman goes to bed and when she wakes up in the morning * how long it takes for a woman to fall asleep after going to bed * changes in sleep problem questionnaire scores to assess how these problems affect a woman's quality of life The data will come from combining all the electronic health record databases, patient related questionnaires, and data from smartwatches that the women will wear on their wrists. The data will be collected between November 2024 to May 2025. In this study, researchers will combine all the electronic data during a 28-day follow-up period. No visits or tests are required as part of this study.

Conditions

• Sleep Disturbances Associated With Menopause

Interventions

Type	Name	Description
OTHER	No study intervention	No visits or examinations, laboratory tests or procedures are mandated or required for this study. Providers in the study recruitment network will recruit eligible patients through an existing visit. After this referral, the study is conducted entirely electronically.

Timeline

• Start date: 2024-12-06
• Primary completion: 2025-08-29
• Completion: 2025-10-27
• First posted: 2024-12-11
• Last updated: 2025-11-25

Locations

1 site across 1 country: United States