Sleep showdown: HRT vs. CBT for menopausal insomnia

NCT ID NCT06497894

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

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.

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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

Contacts and locations

Locations

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

Bern, 3010, Switzerland

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