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New treatment option for Insomnia
Official title No More Sleepless Nights in Perimenopause
ClinicalTrials.gov ID: NCT06497894
What this study is testing
What is Hormone Replacement Therapy (HRT)?
Hormone Replacement Therapy (HRT) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for insomnia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of the clinical trial is to learn if Hormone Replacement Therapy (HRT) and Cognitive Behavioral Therapy (CBT-I) can treat insomnia in menopausal women. The main questions it aims to answer are: Are HRT and CBT-I effective in reducing insomnia in menopausal women?
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 69, women only. Healthy volunteers may be eligible.
You may be able to join if
- Late menopausal transition according to Stages of Reproductive Aging criteria (STRAW+10)
- Pittsburgh Sleep Quality Index (PSQI) score \> 5
- Insomnia Severity Index (ISI) score \> 7
- Somato-vegetative domain of the Menopause Rating Scale (MRS)-II ≥ 4 points
- Willingness to use HRT for menopausal symptom reliefs
You likely can't join if
- Other sleep-wake disorders according to DSM-5, assessed with validated questionnaires (Sleep-Health Questionnaire, Epworth Sleepiness Scale (ESS))
- Untreated hormonal disorder
- Obesity (BMI ≥ 30)
- Current psychotherapy
- Current psychopharmacological therapy including regular sleep medication
- History of unsuccessful CBT-I
See the full eligibility criteria
- Late menopausal transition according to Stages of Reproductive Aging criteria (STRAW+10)
- Pittsburgh Sleep Quality Index (PSQI) score \> 5
- Insomnia Severity Index (ISI) score \> 7
- Somato-vegetative domain of the Menopause Rating Scale (MRS)-II ≥ 4 points
- Willingness to use HRT for menopausal symptom reliefs
- Other sleep-wake disorders according to DSM-5, assessed with validated questionnaires (Sleep-Health Questionnaire, Epworth Sleepiness Scale (ESS))
- Untreated hormonal disorder
- Obesity (BMI ≥ 30)
- Current psychotherapy
- Current psychopharmacological therapy including regular sleep medication
- History of unsuccessful CBT-I
- Psychiatric illness
- Substance abuse (≥ 7 cigarettes/day, no more than 2 standard WHO drinks per day, other drugs)
- Shift work
- Long-haul flights across different time zones in the past 3 months
- Pregnancy and lactation
- Contraindications to HRT according to drug information (https://www.swissmedicinfo.ch/)
- Inability to follow procedures or insufficient knowledge of project language
- Inability to give consent
The study team makes the final eligibility decision.
Where it's taking place
- Bern, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 45 years to 69 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bern, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.