Actively Recruiting
No More Sleepless Nights in Perimenopause
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2026-01-13
54
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
No More Sleepless Nights in Perimenopause
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 Hormone Replacement Therapy for menopausal symptom relief
You will not qualify if you...
- Other sleep-wake disorders according to DSM-5, assessed with validated questionnaires (Sleep-Health Questionnaire, Epworth Sleepiness Scale)
- Untreated hormonal disorder
- Obesity (BMI ≥ 30)
- Current psychotherapy
- Current psychopharmacological therapy including regular sleep medication
- History of unsuccessful Cognitive Behavioral Therapy for Insomnia
- 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 Hormone Replacement Therapy according to drug information
- Inability to follow procedures or insufficient knowledge of project language
- Inability to give consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine
Bern, Switzerland, 3010
Actively Recruiting
Research Team
P
Petra Stute, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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