Effects of Hormone Replacement Therapy on Sleep in the Peri- and Postmenopause
Résumé de l'étude
Women are known to have more difficulties than men in initiating and maintaining satisfactory sleep, which is exacerbated during times of hormonal changes such as during pregnancy or in the peri- and postmenopause. With our study, we aim to determine the effect of an individually tailored and medically indicated menopausal hormone therapy (MHT) on various sleep parameters in peri- and postmenopausal women.
(BASEC)
Intervention étudiée
The study will include 172 women (86 peri- and 86 postmenopausal women). There is no specific study-related MHT, but all MHT preparations approved by Swissmedic may be used based on an individual and patient-centered choice by the treating physician. Participants will be divided into two groups based on their menopausal status - one peri- and one postmenopausal group - and will then be randomized 2:1 into an intervention group (start of MHT after 2 weeks) and a control group (start of MHT with a delay of an additional 6-8 weeks). All participants will be asked to complete questionnaires as well as a sleep diary before and after the start of MHT. For the control group, this will also occur once more during the waiting period until the start of MHT.
(BASEC)
Maladie en cours d'investigation
Sleep disorders
(BASEC)
- Signed informed consent - Peri- and postmenopausal woman - Indication for MHT (e.g., climacteric syndrome, osteoporosis, etc.) - Age ≥ 18 years - German-speaking (BASEC)
Critères d'exclusion
- Pregnancy or lactation - BMI ≥ 30 kg/m² - Status after hysterectomy - Systemic hormone therapy or hormonal contraception (estrogens, progestins, androgens) during the study and within 12 weeks prior to the start of the study - Prescribed medications for the treatment of sleep problems 12 weeks prior to the start of the study (excluding phytotherapeutics and over-the-counter medications) - Medications that could disturb sleep (e.g., antidepressants, anticonvulsants, and antipsychotic medications) - Substance abuse (e.g., daily alcohol consumption, drugs in general) - Contraindications for hormone therapy in menopause according to swissmedicinfo.ch - Known or suspected non-compliance due to inability to follow the study procedures (e.g., illiteracy, language problems, mental disorders, dementia, etc.) (BASEC)
Lieu de l’étude
Bâle, Berne, Zurich
(BASEC)
Sponsor
Susanna Weidlinger
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Susanna Weidlinger
+41 31 632 13 03
susanna.weidlinger@clutterinsel.chAbtl. für Gynäkologische Endokrinologie und Reproduktionsmedizin Universitätsklinik für Frauenheilkunde Inselspital Bern Friedbühlstrasse 19 CH - 3010 Bern
(BASEC)
Informations scientifiques
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Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Berne
(BASEC)
Date d'approbation du comité d'éthique
16.05.2024
(BASEC)
Identifiant de l'essai ICTRP
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Titre officiel (approuvé par le comité d'éthique)
Effect of menopausal hormone therapy on sleep (BASEC)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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