ArticleTrials2025
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 cognitive behavioral therapy for the treatment of insomnia: study protocol.
Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06497894 (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 Cognitive Behavioral Therapy), which is not on this map. Cited by 1 paper.
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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 Cognitive Behavioral Therapy
Who cites it
1 citing paper in PubMed.
- Optimizing Healthspan in Women: A New Paradigm for Successful Aging through the Menopausal Transition.Journal of menopausal medicine · 2026Review
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Authors and funding
5 authors.
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No grant is acknowledged in the PubMed record.
Abstract
objectivesCognitive behavioral therapy for insomnia (CBT-I) will be compared with hormone replacement therapy (HRT) and sleep hygiene (active control treatment).
backgroundThe 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.
methodsFifty-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.
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