End sleepless nights during perimenopause.
Official title: 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
Run by Insel Gruppe AG, University Hospital Bern · NCT06497894 · Data updated 2026-11-12
This trial will test whether hormone replacement therapy or weekly cognitive behavioral therapy for insomnia helps perimenopausal women with insomnia sleep better than weekly sleep-hygiene advice.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 45 Years to 69 Years |
| Sex | Women only |
| Enrollment | 54 (estimated) |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | July 1, 2026 |
| Study ends | January 30, 2027 |
| Registry record updated | January 13, 2026 |
| Trial ID | NCT06497894 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are perimenopausal women in the late menopausal transition with PSQI > 5, ISI > 7, a somato-vegetative MRS-II score ≥ 4, willingness to use HRT, and ability to attend weekly sessions and EEG visits at the Bern site.
✕Probably not a fit
Women with other untreated sleep-wake disorders, obesity (BMI ≥ 30), current psychotherapy or psychotropic medications, psychiatric illness, substance abuse, contraindications to HRT, pregnancy or lactation, shift work, or recent long-haul travel are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Perimenopausal women who meet specified insomnia and menopausal symptom thresholds are assigned to eight weeks of either hormone replacement therapy (HRT as prescribed), weekly cognitive behavioral therapy for insomnia (CBT-I), or weekly sleep-hygiene instructions as an active control. Participants complete screening, baseline and post-intervention assessments, keep a daily electronic sleep diary, and wear an EEG for three nights at baseline and three nights after the intervention to measure sleep architecture and awakenings. Adherence is supported by weekly phone calls and the protocol excludes individuals with other untreated sleep disorders, obesity, current psychotropic treatment, psychiatric illness, substance abuse, or contraindications to HRT. The trial is conducted at the University Hospital of Bern and focuses on practical, clinic-delivered interventions over an eight-week period.
Why it matters
Potential benefit: If successful, the trial could show which approach—HRT or CBT-I—provides meaningful sleep improvement in perimenopausal women and help guide personalized treatment choices.
How similar studies have gone: CBT-I has strong evidence for treating insomnia including in midlife women and HRT can improve sleep by reducing vasomotor symptoms, but direct head-to-head comparisons of HRT versus CBT-I in perimenopause are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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
Where it's running
-
University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine
Bern, Switzerland Recruiting
Study contacts
- Principal investigator: Petra Stute, Prof. — University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine
- Study coordinator: Petra Stute, Prof.
- Email: petra.stute@insel.ch
- Phone: +41 31 632 1010
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.