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 cogn

Objectives Cognitive behavioral therapy for insomnia (CBT-I) will be compared with hormone replacement therapy (HRT) and sleep hygiene (active control treatment).Background The late menopausal transition is a vulnerable hormonal phase for women, where sleep disorders and vasomotor symptoms affect one out of three women. HRT is probably the most commonly used method to treat menopausal symptoms, including sleep problems. However, CBT-I is considered the treatment of choice for insomnia in adults in general. Despite this fact, there are only a few studies that have examined the effect of CBT-I in peri- and postmenopause and only one observational study comparing CBT-I and HRT for perimenopausal insomnia. Therefore, this study aims to compare the efficacy of HRT and CBT-I on subjective and objective sleep quality.Methods Fifty-four late perimenopausal women will be randomly assigned to receive psychotherapist-led CBT-I, HRT (transdermal estradiol 1.5 mg/d and oral micronized progesterone 200 mg/day), or sleep hygiene (active control). Sleep quality will be continually assessed for 3 months, using validated questionnaires and an in-ear EEG device. Moreover, potential changes in the biofunctional status and age (27) and vasomotor symptoms will be assessed.Discussion The goal is to enable evidence-based treatment decisions for affected women to close the menopausal medical care gap and improve women's quality of life. TRIAL REGISTRATION {2A, 2B}: The study has been registered at ClinicalTrials.gov (Identifier: NCT06497894) on 11 July 2024. URL: (https://clinicaltrials.gov/ct2/show/NCT06497894). PROTOCOL VERSION AND TRIAL STATUS {3}: Protocol version 3.1 (30. April 2024). Recruitment has not started yet (15. August 2024). The recruitment is planned to begin on 01. November 2024, with an estimated completion date of 01. April 2026.