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No More Sleepless Nights in Perimenopause

RecruitingPhase 4Ages 45 Years - 69 YearsFemaleInsel Gruppe AG, University Hospital Bern
NCT06497894 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Cognitive Behavioural Therapy for Insomnia (CBT-I)
  • Hormone Replacement Therapy (HRT)
  • Sleep Hygiene
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Where

1 site
University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine
Bern, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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