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

NCT06728332 | Completed

• 1 other identifier: 22815
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (9)

• Number of awakenings in the night.

  From Day 1 to Day 28.

• Mean WASO (wakefulness after sleep onset)

  Total number of minutes that a participant is awake after having initially fallen asleep

  From Day 1 to Day 28

• Mean number of moderate or severe hot flashes per night

  From Day 1 to Day 28

• Mean sleep efficiency score

  Defined as the percentage of time spent asleep while in bed

  From Day 1 to Day 28

• Mean length of time (in minutes) to fall asleep

  From Day 1 to Day 28

• Mean total sleep disturbance score (T-score) derived from PROMIS-SD-SF-8b

  PROMIS-SD-SF-8B: Patient-reported Outcomes Measurement Information System Sleep disturbance short form 8b.

  Day 1, Day 14 and Day 28

• Menopause-specific quality-of-life questionnaire (MENQOL) total score

  Measured by ePRO.

  Day 1, Day 14 and Day 28

• Insomnia Severity Index (ISI) total Score

  Day 1, Day 14 and Day 28

• Socioeconomic status short-form questionnaire

  Day 0

Secondary Outcomes (18)

• Descriptive analysis of demographics

  Day 0

• Descriptive analysis of clinical characteristics

  Day 0

• Lifestyle questionnaire

  Day 0

• Comorbid conditions and dates of diagnosis from patient EHR (electronic health record)

  Day 0

• Concomitant medications, from patient medication survey

  Day 0

Study Arms (1)

Group 1

Females experiencing sleep disturbances associated with menopause

Other: No study intervention

Interventions

No study intervention OTHER

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.

Group 1

Eligibility Criteria

• Age: 40 Years - 65 Years
• Gender Eligibility Details: Women experiencing menopause assigned female at birth
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Females from 40 to 65 years (inclusive) experiencing sleep disturbances associated with menopause.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Bayer

Whippany, New Jersey, 07981, United States

Location

Related Links

• Click here for access to information about Bayer's transparency standards and Bayer studies.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: December 11, 2024
• Study Start: December 6, 2024
• Primary Completion: August 29, 2025
• Study Completion: October 27, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)