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NCT06497894 | NOT YET RECRUITING | Insomnia

No More Sleepless Nights in Perimenopause
Sponsor:

Insel Group AG, University Hospital Bern

Brief Summary:

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? * Are HRT and CBT-I comparable in terms of reducing insomnia severity in this population? Researchers will compare HRT and CBT-I to an active control group, receiving sleep hygiene instructions. Participants will: * Complete a screening and baseline assessment * Receive Hormone Replacement Therapy (as prescribed), Cognitive Behavioral Therapy (1/week), or sleep hygiene instructions (1/week) for 8 weeks. * Keep a daily diary (sleep e-diary), to assess sleep-quality. * Wear an electroencephalogram (EEG) during 6 nights (3 at baseline \& 3 post-intervention), to assess deep sleep cycles and waking episodes. * Receive a phone call for intervention compliance * Complete a post-intervention assessment.

Condition or disease

Insomnia

Menopause

Intervention/treatment

Cognitive Behavioural Therapy for Insomnia (CBT-I)

Hormone Replacement Therapy (HRT)

Sleep Hygiene

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 54 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2025-08-01
Estimated Primary Completion Date : 2026-07-01
Estimated Study Completion Date : 2027-01-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 45 Years to 69 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: 1
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
No More Sleepless Nights in Perimenopause

Location Details

NCT06497894

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Switzerland,

University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine

Bern, Switzerland, 3010