No More Sleepless Nights in Perimenopause

No More Sleepless Nights in Perimenopause - an Open Label, Randomized, Parallel-group, Active Controlled Intervention Study in Perimenopausal Women With Vasomotor Symptoms and Insomnia to Investigate the Efficacy of Hormone Replacement Therapy and Cognitive Behavioral Therapy

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.

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