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Taking peoplePhase 4

No More Sleepless Nights in Perimenopause

Key facts

Who runs it
Insel Gruppe AG, University Hospital Bern
Where
Switzerland1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
Phase
Phase 4
People taking part
54 people, planned
Started
1 Jan 2026
Expected to end
30 Jan 2027
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Cognitive Behavioural Therapy for Insomnia (CBT-I)
  • Hormone Replacement Therapy (HRT)
  • Sleep Hygiene
Record updated
13 January 2026

Who can take part

Age
45 years to 69 years
Sex
Women only
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Current psychopharmacological therapy including regular sleep medication
  • Substance abuse (≥ 7 cigarettes/day, no more than 2 standard WHO drinks per day, other drugs)
  • Contraindications to HRT according to drug information (https://www.swissmedicinfo.ch/)
  • Other sleep-wake disorders according to DSM-5, assessed with validated questionnaires (Sleep-Health Questionnaire, Epworth Sleepiness Scale (ESS))
  • Untreated hormonal disorder
  • History of unsuccessful CBT-I
  • Psychiatric illness
  • Obesity (BMI ≥ 30)
  • Current psychotherapy
  • Shift work
  • Long-haul flights across different time zones in the past 3 months
  • Pregnancy and lactation
  • Inability to follow procedures or insufficient knowledge of project language
  • Inability to give consent

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 45 and 69 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

* 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.

The 3 groups in the trial

  • Cognitive Behavioral Therapy for insomnia (CBT-I)Treatment being tested

    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: Cognitive Behavioural Therapy for Insomnia (CBT-I)

  • Hormone Replacement Therapy (HRT)Existing treatment, for comparison

    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.

  • Sleep HygieneSham treatment, for comparison

    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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Fit questions
Built from NCT06497894, who can take part
Publications
Record updated
13 January 2026