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Menopause sleep study seeks answers to end sleepless nights

NCT ID NCT06728332

Knowledge-focused Sponsor: Bayer Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at sleep disturbances in 750 women going through menopause. Researchers collected data from health records, questionnaires, and smartwatches to understand how often women wake up at night and how it affects their quality of life. The goal was to learn more about these sleep problems and current treatments, so better options can be developed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

750 people

The number who actually took part.

Started

Dec 2024

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

40 to 65 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sleep disturbances associated with menopause

Contacts and locations

Locations

  • Bayer

    Whippany, New Jersey, 07981, United States

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