Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Sleep showdown: HRT vs. CBT for menopausal insomnia

NCT ID NCT06497894

Symptom relief Sponsor: Insel Gruppe AG, University Hospital Bern Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether hormone replacement therapy (HRT) or cognitive behavioral therapy (CBT-I) can help perimenopausal women sleep better. Fifty-four women with insomnia and hot flashes will receive either HRT, weekly CBT-I sessions, or sleep hygiene tips for 8 weeks. Researchers will track sleep quality using diaries and brain-wave monitors to see which approach works best.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Hormone Replacement Therapy (HRT) and Cognitive Behavioral Therapy for Insomnia (CBT-I)
What this could lead to
If successful, this could show that CBT-I is a safe, non-drug option for treating insomnia in menopausal women, or confirm HRT's effectiveness for sleep.
What could go wrong
This is a small Phase 4 trial with only 54 participants, so results may not apply to everyone. Both treatments have limitations and may not work for all women.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 54 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

45 to 69 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: * Late menopausal transition according to Stages of Reproductive Aging criteria (STRAW+10) * Pittsburgh Sleep Quality Index (PSQI) score \> 5 * Insomnia Severity Index (ISI) score \> 7 * Somato-vegetative domain of the Menopause Rating Scale (MRS)-II ≥ 4 points * Willingness to use HRT for menopausal symptom reliefs Exclusion Criteria: * Other sleep-wake disorders according to DSM-5, assessed with validated questionnaires (Sleep-Health Questionnaire, Epworth Sleepiness Scale (ESS)) * Untreated hormonal disorder * Obesity (BMI ≥ 30) * Current psychotherapy * Current psychopharmacological therapy including regular sleep medication * History of unsuccessful CBT-I * Psychiatric illness * Substance abuse (≥ 7 cigarettes/day, no more than 2 standard WHO drinks per day, other drugs) * Shift work * Long-haul flights across different time zones in the past 3 months * Pregnancy and lactation * Contraindications to HRT according to drug information (https://www.swissmedicinfo.ch/) * Inability to follow procedures or insufficient knowledge of project language * Inability to give consent

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Insomnia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

insomnia

As listed by the trial registrant

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

Insomnia Menopause

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine

    RECRUITING

    Bern, 3010, Switzerland

More trials for these conditions

Other studies related to the condition(s) this trial covers.