Sleeping Through Menopause
Key facts
- Phase
- Phase 4
This trial has no sites in United States.
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Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 55 years old?
Source: NCT06306404, who can take part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- VU University of Amsterdam
- Trial code
- NCT06306404EU 2024-512071-12-00
- Record updated
- 24 August 2025
- Original description
Sleepless nights during the menopausal period: what treatment works? About half of the women have trouble sleeping during the years around the menopause, the perimenopause. This is a period characterised by fluctuating sex hormones. Insomnia during the perimenopause can make women more likely to develop more severe climacteric symptoms and other mental health problems. It is therefore important to find the right treatment to treat insomnia. Currently, we do not know what the best treatment is for managing insomnia during the perimenopause. The Sleeping Through Menopause study is the first to evaluate, side by side, two interventions: menopausal hormone therapy (MHT) and combined cognitive behavioural and circadian therapy for insomnia (CBCTi). The study aims to evaluate how well these treatments alleviate insomnia and climacteric symptoms including hot flashes, and by doing so alleviate or prevent other mental health issues. It will also explore how personal factors might affect treatment success.Read full original descriptionShow less
The Role of Online Sleep Intervention and Hormone Therapy on Sleep, Climacteric Symptoms and Mood in the Perimenopause
Sleepless nights during the menopausal period: what treatment works? About half of the women have trouble sleeping during the years around the menopause, the perimenopause. This is a period characterised by fluctuating sex hormones. Insomnia during the perimenopause can make women more likely to develop more severe climacteric symptoms and other mental health problems. It is therefore important to find the right treatment to treat insomnia. Currently, we do not know what the best treatment is for managing insomnia during the perimenopause. The Sleeping Through Menopause study is the first to evaluate, side by side, two interventions: menopausal hormone therapy (MHT) and combined cognitive behavioural and circadian therapy for insomnia (CBCTi). The study aims to evaluate how well these treatments alleviate insomnia and climacteric symptoms including hot flashes, and by doing so alleviate or prevent other mental health issues. It will also explore how personal factors might affect treatment success.
In the study, 222 women with both insomnia and climacteric symptoms will be randomly assigned to one of four groups: MHT, CBCTi, a combination of both MHT and CBCTi, or a group with no treatment. The main goal is to evaluate how each treatment alleviates insomnia after 8 and 15 weeks. Secondary outcomes are sleep quality, climacteric symptoms including hot flashes, mental health, and daily functioning.
This study will help us understand the best ways to treat sleep problems during menopause and whether better sleep can improve other mental health and menopausal symptoms as well.
Inclusion: Age between 40-55 years old; Insomnia severity index score =>10; Green Climacteric Score =>13; Self-considered capability of completing online questionnaires and diaries in Dutch/English; Presence of a menstruation (whether regular or not) and the last menstruation must be less than 12 months ago.
Exclusion: Contra-indication for Menopausal Hormone Therapy; Alcohol or drugs dependency (scores of ≥ 20 on the AUDIT and ≥25 on the DUDIT); Women using thyroid medication, lamotrigine, aromatase, tamoxifen, because of interaction effects with MHT; Use of drugs known to interfere with cytochrome P450 enzyme (CYP) 3A4; Bipolar disorder or psychotic disorder; Known hypersensitivity to the excipients in the estradiol patch: acrylate copolymer, polyethylene terephthalate, alfa-tocopherol, soy allergy (component of progesterone capsule); CBTi treatment in past year; All women on hormonal contraceptives will be excluded; All women already on MHT will be excluded.