Clinical trial NCT06497894: No More Sleepless Nights in 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Insomnia
Menopause
Keywords: Perimenopause
Insomnia
Cognitive Behavioral Therapy
Hormone Replacement Therapy
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 54
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Reduction of Insomnia Severity
timeFrame: Week 10
Secondary outcomes:
measure: Improvement in Climacteric Syndrome
timeFrame: Week 10
measure: Changes in bio-functional age
timeFrame: Week 10
measure: Changes in maladaptive sleep-related cognitions
timeFrame: Week 10
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine
Study officials:
affiliation: University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine
name: Petra Stute, Prof.
role: PRINCIPAL_INVESTIGATOR
References: