No More Sleepless Nights in Perimenopause

Sponsor
Insel Gruppe AG, University Hospital Bern
Study ID
NCT06497894
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
45 Years - 69 Years
Healthy Volunteers
Accepted

Interventions

  • Cognitive Behavioural Therapy for Insomnia (CBT-I) — BEHAVIORAL
    CBT-I is conducted in an individual setting according to the manual used in McCurry (1). Factors at the level of behavior, cognitions, and physiology that perpetuate sleep onset and sleep maintenance disorders are addressed. In addition, psychoeducation on sleep and sleep hygiene, stimulus control, sleep restriction, relaxation, structured worry time, cognitive restructuring, and relapse prevention are part of the training. Each session will include homework.
  • Hormone Replacement Therapy (HRT) — DRUG
    Standard-dose continuously-combined bio-identical HRT containing transdermal estradiol 1.5 mg/d (= 2 strokes of Oestrogel® Dispenser) and oral micronized progesterone (= 1 capsule of Utrogestan® 200). This combination is the most popular HRT regimen, as it has a neutral effect on lipids, glucose, haemostasis. Participants will receive a conventional prescription for the 2 products that are covered by all health insurances in Switzerland.
  • Sleep Hygiene — BEHAVIORAL
    Sleep hygiene refers to healthy sleep habits, e.g. food and drink choices, a regular sleep schedule, evening routine. Although being widely used in daily practice, sleep hygiene shows no significant effect as monotherapy in patients with an established insomnia. The sleep hygiene condition in this study is matched to CBT-I in frequency and intensity of contact.

Study Details

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.

Key Dates

First listed
Jul 12, 2024
Start date
Jan 1, 2026
Status verified
Jan 2026
Primary completion
Jul 1, 2026
Completion
Jan 30, 2027

Study Design

Enrollment
54 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cognitive Behavioral Therapy for insomnia (CBT-I)
    Participants in this experimental arm will receive cognitive behavioral therapy specifically designed to treat insomnia (CBT-I). The therapy will be delivered over 8 weekly sessions, each lasting 60 minutes. The sessions will include techniques such as sleep restriction, stimulus control, cognitive restructuring, and relaxation training. The primary goal is to improve sleep quality and reduce the severity of insomnia.
  • Active Comparator: Hormone Replacement Therapy (HRT)
    Participants in this experimental arm will receive hormone replacement therapy, specifically a combination of estrogen and progesterone over the course of 8 weeks. The therapy aims to alleviate menopausal symptoms, including insomnia, by addressing hormonal imbalances.
  • Sham Comparator: Sleep Hygiene
    Participants in this sham comparator arm will receive sleep hygiene instructions. Instructions will be delivered over 8 weekly sessions. The instructions will provide general information about healthy sleep habits, such as food and drink choices, a regular sleep schedule, evening routine, etc. Although being widely used in daily clinical practice, sleep hygiene shows no significant effect as monotherapy in patients with an established insomnia. The sleep hygiene condition in this study is matched to CBT-I in frequency and intensity of contact.

Primary Outcome Measure

Reduction of Insomnia Severity [ Time Frame: Week 10 ]

Central Contacts

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