No More Sleepless Nights in Perimenopause (NCT06497894) | Clinical Trial Compass
RecruitingPhase 4
No More Sleepless Nights in Perimenopause
Switzerland54 participantsStarted 2026-01-01
Plain-language 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.
Who can participate
Age range
45 Years – 69 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.