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
Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Drug
Study Type: Interventional
Study Phase: Phase 4
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 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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 45
Maximum Age: 69
Healthy Volunteers: t
View:
• 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
Locations
Other Locations
Switzerland
University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine
RECRUITING
Bern
Contact Information
Primary
Petra Stute, Prof.
petra.stute@insel.ch
+41 31 632 1010
Time Frame
Start Date:2026-01-01
Estimated Completion Date:2027-01-30
Participants
Target number of participants:54
Treatments
Experimental: Cognitive Behavioral Therapy for insomnia (CBT-I)
Participants in this experimental arm will receive cognitive behavioral therapy specifically designed to treat insomnia (CBT-I). The therapy will be delivered over 8 weekly sessions, each lasting 60 minutes. The sessions will include techniques such as sleep restriction, stimulus control, cognitive restructuring, and relaxation training. The primary goal is to improve sleep quality and reduce the severity of insomnia.
Participants in this experimental arm will receive hormone replacement therapy, specifically a combination of estrogen and progesterone over the course of 8 weeks. The therapy aims to alleviate menopausal symptoms, including insomnia, by addressing hormonal imbalances.
Sham_comparator: Sleep Hygiene
Participants in this sham comparator arm will receive sleep hygiene instructions. Instructions will be delivered over 8 weekly sessions. The instructions will provide general information about healthy sleep habits, such as food and drink choices, a regular sleep schedule, evening routine, etc. Although being widely used in daily clinical practice, sleep hygiene shows no significant effect as monotherapy in patients with an established insomnia. The sleep hygiene condition in this study is matched to CBT-I in frequency and intensity of contact.