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OpenTrials
Completed

NCT Number: NCT06728332

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

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.

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Key information

Age range

40 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Bayer

Whippany, New Jersey, 07981, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Number of awakenings in the night.

    Time frame: From Day 1 to Day 28.

  2. Mean WASO (wakefulness after sleep onset)

    Time frame: From Day 1 to Day 28

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

  3. Mean number of moderate or severe hot flashes per night

    Time frame: From Day 1 to Day 28

  4. Mean sleep efficiency score

    Time frame: From Day 1 to Day 28

    Defined as the percentage of time spent asleep while in bed

  5. Mean length of time (in minutes) to fall asleep

    Time frame: From Day 1 to Day 28

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

    Time frame: Day 1, Day 14 and Day 28

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

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

    Time frame: Day 1, Day 14 and Day 28

    Measured by ePRO.

  8. Insomnia Severity Index (ISI) total Score

    Time frame: Day 1, Day 14 and Day 28

  9. Socioeconomic status short-form questionnaire

    Time frame: Day 0

Secondary outcomes

  1. Descriptive analysis of demographics

    Time frame: Day 0

  2. Descriptive analysis of clinical characteristics

    Time frame: Day 0

  3. Lifestyle questionnaire

    Time frame: Day 0

    Questionnaire includes smoking history, alcohol consumption, caffeine consumption, other persons in the home and work schedule.

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

    Time frame: Day 0

  5. Concomitant medications, from patient medication survey

    Time frame: Day 0

  6. Body mass index (BMI)

    Time frame: Day 0

  7. Number of previous pregnancies from patient EHR

    Time frame: Day 0

  8. Non-pharmacologic treatments for sleep disturbances

    Time frame: Day 0

  9. Number of EHR (electronic Health record) documented prescriptions for sleep disturbances.

    Time frame: Retrospective analysis from 12 months prior to ICF

  10. Number of patient-reported medications and supplements for sleep disturbances.

    Time frame: From 6 months prior Day 1

  11. Number of patients reporting alternative treatment/management for sleep disturbances

    Time frame: Day 0

  12. Questionnaire of satisfaction score for medications and supplements used to treat sleep disturbances.

    Time frame: From 6 months prior Day 1

  13. Names of prescription and non-prescription medications and supplements for sleep disturbances reported in Daily Morning Diaries, including dosage.

    Time frame: Day 1 to Day 28

  14. List of types of treatment formerly prescribed for sleep disturbances, from patient medication survey.

    Time frame: Day 0

  15. Duration of treatments formerly prescribed for sleep disturbances, by drug class, from patient medication survey.

    Time frame: Day 0

  16. Proportion of days PRN medication used.

    Time frame: From Day 1 to Day 28

  17. Among medications for sleep disturbances discontinued within 6 months of enrollment, patient reported reason for discontinuation.

    Time frame: Day 0

  18. HADS (Hospital Anxiety and Depression Scale) total score.

    Time frame: Day 0

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

ESTeeM: Evaluation of Sleep Disturbances in Menopause

Acronym: ESTeeM

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 11, 2024
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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