Status:
NOT_YET_RECRUITING
No More Sleepless Nights in Perimenopause
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Insomnia
Menopause
Eligibility:
FEMALE
45-69 years
Phase:
PHASE4
Brief Summary
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 ar...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2027
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT06497894
Start Date
August 1 2025
End Date
January 30 2027
Last Update
May 15 2025
Active Locations (1)
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1
University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine
Bern, Switzerland, 3010