End sleepless nights during perimenopause.
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
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 |
| Enrollment | 54 (estimated) |
| Ages | 45 Years to 69 Years |
| Sex | Female |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT06497894 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bern
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.