Effects of Hormone Replacement Therapy on Sleep in the Peri- and Postmenopause
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
- 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)
Luogo dello studio
Basilea, Berna, Zurigo
(BASEC)
Sponsor
Susanna Weidlinger
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
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)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Berna
(BASEC)
Data di approvazione del comitato etico
16.05.2024
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
Effect of menopausal hormone therapy on sleep (BASEC)
Titolo accademico
non disponibile
Titolo pubblico
non disponibile
Malattie studiate
non disponibile
Intervento studiato
non disponibile
Tipo di studio
non disponibile
Disegno dello studio
non disponibile
Criteri di inclusione/esclusione
non disponibile
non disponibile
Endpoint primari e secondari
non disponibile
non disponibile
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
non disponibile
ID secondari
non disponibile
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
non disponibile
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile