No More Sleepless Nights in Perimenopause

Recruiting now · Phase 4

Conditions studied: Insomnia, Menopause

In brief

The goal of the clinical trial is to learn if Hormone Replacement Therapy (HRT) and Cognitive Behavioral Therapy (CBT-I) can treat insomnia in menopausal women. The main questions it aims to answer are: * Are HRT and CBT-I effective in reducing insomnia in menopausal women? * Are HRT and CBT-I comparable in terms of reducing insomnia severity in this population? Researchers will compare HRT and CBT-I to an active control group, receiving sleep hygiene instructions. Participants will: * Complete a screening and baseline assessment * Receive Hormone Replacement Therapy (as prescribed), Cognitive Behavioral Therapy (1/week), or sleep hygiene instructions (1/week) for 8 weeks. * Keep a daily diary (sleep e-diary), to assess sleep-quality. * Wear an electroencephalogram (EEG) during 6 nights (3 at baseline \& 3 post-intervention), to assess deep sleep cycles and waking episodes. * Receive a phone call for intervention compliance * Complete a post-intervention assessment.

Key facts

Study ID

NCT06497894

Run by

Insel Gruppe AG, University Hospital Bern

People needed

54

Starts

2026-01-01

Expected to finish

2027-01-30

Last updated by the study team

2026-01-13

Who can join

Age: 45 and older, up to 69. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine — Bern, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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