No More Sleepless Nights in Perimenopause
1 other identifier
interventional
54
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2026
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 4, 2024
CompletedFirst Posted
Study publicly available on registry
July 12, 2024
CompletedStudy Start
First participant enrolled
January 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 30, 2027
January 13, 2026
January 1, 2026
6 months
July 4, 2024
January 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction of Insomnia Severity
Change from baseline in Insomnia Severity Index (ISI). The ISI is a seven-item questionnaire, asking respondents to rate the severity of sleep-related symptoms on 5-point Likert scales (Ranging between 0 = not applicable and 4 = very strong). Total values may range between 0 and 28, where 0 indicates no presence of sleep-related symptoms and 28 indicates very severe symptoms.
Week 10
Secondary Outcomes (3)
Improvement in Climacteric Syndrome
Week 10
Changes in bio-functional age
Week 10
Changes in maladaptive sleep-related cognitions
Week 10
Study Arms (3)
Cognitive Behavioral Therapy for insomnia (CBT-I)
EXPERIMENTALParticipants 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.
Hormone Replacement Therapy (HRT)
ACTIVE COMPARATORParticipants 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.
Sleep Hygiene
SHAM COMPARATORParticipants 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.
Interventions
CBT-I is conducted in an individual setting according to the manual used in McCurry (1). Factors at the level of behavior, cognitions, and physiology that perpetuate sleep onset and sleep maintenance disorders are addressed. In addition, psychoeducation on sleep and sleep hygiene, stimulus control, sleep restriction, relaxation, structured worry time, cognitive restructuring, and relapse prevention are part of the training. Each session will include homework.
Standard-dose continuously-combined bio-identical HRT containing transdermal estradiol 1.5 mg/d (= 2 strokes of Oestrogel® Dispenser) and oral micronized progesterone (= 1 capsule of Utrogestan® 200). This combination is the most popular HRT regimen, as it has a neutral effect on lipids, glucose, haemostasis. Participants will receive a conventional prescription for the 2 products that are covered by all health insurances in Switzerland.
Sleep hygiene refers to healthy sleep habits, e.g. food and drink choices, a regular sleep schedule, evening routine. Although being widely used in daily 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine
Bern, 3010, Switzerland
Related Publications (1)
Pavicic E, Stute P, Rudzik F, Urech A, Lozza-Fiacco S. 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 for the treatment of insomnia: study protocol. Trials. 2025 Dec 30;27(1):94. doi: 10.1186/s13063-025-09366-9.
PMID: 41462320DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Petra Stute, Prof.
University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2024
First Posted
July 12, 2024
Study Start
January 1, 2026
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
January 30, 2027
Last Updated
January 13, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share