The Effect of Menopausal Hormone Therapy on Sleep (menoSLEEP) study is investigating the effects of menopausal hormone therapy (MHT) on sleep problems in peri- and postmenopausal women with an indication for MHT. The aim of the study is to find out whether MHT improves subjective and objective sleep quality in these women. The primary objective is to measure sleep quality using several sleep-specific questionnaires and a sleep protocol.
The study is a multicentre, prospective, unblinded, randomised controlled trial involving 172 women. Participants will be divided into groups that will either receive MHT or act as a control group. All participants will complete seven questionnaires before and after MHT and keep a sleep diary. The duration of participation will vary between 8 and 16 weeks. The results should help to improve the treatment of menopausal sleep disorders and the quality of life of women affected.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
* Informed Consent as documented by signature
* Peri- and postmenopausal woman
* Indication for MHT (e.g. climacteric syndrome, osteoporosis, etc.)
* Age ≥ 18 years
* German Speaking
Exclusion Criteria:
* Obesity BMI ≥ 30 kg/m²
* Pregnancy or Lactation
* Status post Hysterectomy
* Systemic hormone therapy or hormonal contraception (estrogens, progestogens, androgens) during the study and within 12 weeks prior to study entry
* Prescribed medication for therapy of sleep problems 12 weeks prior to study entry (excluding phytotherapeutic agents and over the counter medication)
* Medication that could distort sleep (e.g. antidepressant, anticonvulsant and antipsychotic medications)
* Substance abuse (e.g. daily alcohol consumption, drugs in general)
* Contraindication for menopausal hormone therapy according to swissmedicinfo.ch
* Neoplasia of the breast or other sexual organ
* Benign or malignant liver tumors
* Acute or chronic liver disease
* Cholestatic jaundice
* Porphyria
* Arterial or venous thromboembolic events
* Abnormal genital bleeding of unknown cause
* Known or suspected non-compliance due to inability to follow the procedures of the study (e.g. illiteracy, language problems, psychological disorders, dementia, etc.)
Primary outcome measure(s)
Sleep Quality — 8-16 weeks Sleep quality measured with the Insomnia Severity Index (ISI), a 7-item self-report questionnaire. Each item is rated on a 5-point Likert scale from 0 to 4, yielding a total score ranging from 0 to 28. Higher scores indicate greater insomnia severity and poorer sleep quality.
Sleep Quality — 8-16 weeks Subjective sleep quality assessed using a 2-week sleep protocol with daily ratings on a 9-point Likert scale (range: 1-9). Higher scores indicate better subjective sleep quality.
Trial sites (1)
Facility
City
Region
Status
Inselspital Bern, Frauenklinik
Bern
Switzerland
More Insel Gruppe AG, University Hospital Bern trials in Switzerland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
