No More Sleepless Nights in Perimenopause

Insel Gruppe AG, University Hospital Bern

Status and phase: Not yet enrolling; Phase 4

Conditions: Menopause; Insomnia

Treatments: Behavioral: Cognitive Behavioural Therapy for Insomnia (CBT-I); Behavioral: Sleep Hygiene; Drug: Hormone Replacement Therapy (HRT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06497894

2023-00209

Details and patient eligibility

About

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.

Enrollment: 54 estimated patients

Sex: Female

Ages: 45 to 69 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 3 patient groups

Cognitive Behavioral Therapy for insomnia (CBT-I)

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Behavioural Therapy for Insomnia (CBT-I)

Hormone Replacement Therapy (HRT)

Active Comparator group

Description:

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.

Treatment:

Drug: Hormone Replacement Therapy (HRT)

Sleep Hygiene

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Sleep Hygiene