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NCT Number: NCT06497894

No More Sleepless Nights in Perimenopause

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.

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Key information

Conditions

Insomnia Dyssomnias Menopause Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

45 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

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

Bern, 3010, Switzerland

Location status: Recruiting

Location contact

Petra Stute, Prof.

CONTACT

+41 31 632 1010

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Reduction of Insomnia Severity

    Time frame: Week 10

    Change from baseline in Insomnia Severity Index (ISI). The ISI is a seven-item questionnaire, asking respondents to rate the severity of sleep-related symptoms on 5-point Likert scales (Ranging between 0 = not applicable and 4 = very strong). Total values may range between 0 and 28, where 0 indicates no presence of sleep-related symptoms and 28 indicates very severe symptoms.

Secondary outcomes

  1. Improvement in Climacteric Syndrome

    Time frame: Week 10

    Change from baseline in Menopause Rating Scale (MRS-II) The MRS-II is an eleven-item questionnaire, asking respondents to rate the severity of climcteric syndrome-related symptoms on 5-point Likert scales (Ranging between 0 = not applicable and 4 = very strong). Total values may range between 0 and 44, where 0 indicates no presence of symptoms and 44 indicates very severe symptoms.

  2. Changes in bio-functional age

    Time frame: Week 10

    Change from baseline in biofunctional status (i.e. differences between chronological age and biofunctional age).

  3. Changes in maladaptive sleep-related cognitions

    Time frame: Week 10

    Change from baseline in Dysfunctional Attitudes and Beliefs about Sleep Scale (DBAS).

    The DBAS is a sixteen-item questionnaire, asking respondents to rate their attitudes/beliefs about sleep on 10-point numerical rating-scales (discrete intervals), ranging between 0 (I do not agree at all) and 10 (I agree completely). Total values may range between 0 and 160, where 0 indicates no presence of dysfunctional attitudes and 160 indicates very severe levels of maladaptive sleep-related cognitions.

Study contacts

Contact information is provided by the study sponsor or research team.

Petra Stute, Prof.

CONTACT

[email protected]

+41 31 632 1010

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 12, 2024
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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