ESTeeM: Evaluation of Sleep Disturbances in Menopause

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 40
Maximum Age: 65
Healthy Volunteers: t
View:

• 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.

Locations
United States
New Jersey
Bayer
RECRUITING
Whippany
Contact Information
Primary
Bayer Clinical Trials Contact
clinical-trials-contact@bayer.com
(+)1-888-84 22937
Time Frame
Start Date: 2024-12-06
Estimated Completion Date: 2025-05-20
Participants
Target number of participants: 1000
Treatments
Group 1
Females experiencing sleep disturbances associated with menopause
Related Therapeutic Areas
Sponsors
Leads: Bayer

This content was sourced from clinicaltrials.gov