InsomniaPhase 4NCT06497894
No More Sleepless Nights in Perimenopause
A Phase 4 study testing Cognitive Behavioural Therapy for Insomnia (CBT-I), Hormone Replacement Therapy (HRT) and Sleep Hygiene in people with Insomnia and Menopause, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 69 years, women onlyHealthy volunteers can take part
- What is being tested?
- Cognitive Behavioural Therapy for Insomnia (CBT-I), Hormone Replacement Therapy (HRT) and Sleep Hygiene
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2026to 30 Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Show all 14Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine
Bern, 3010
Petra Stute, Prof., +41 31 632 1010
About this study
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
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?
Read more
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.
- Being tested
- Cognitive Behavioural Therapy for Insomnia (CBT-I), Hormone Replacement Therapy (HRT), Sleep Hygiene
- Keywords
- Perimenopause, Insomnia, Cognitive Behavioral Therapy, Hormone Replacement Therapy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural Therapy for Insomnia (CBT-I)Behavioural
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 HygieneBehavioural
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 group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy for insomnia (CBT-I) | Experimental | 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. Receives: Behavioral: Cognitive Behavioural Therapy for Insomnia (CBT-I) |
| Hormone Replacement Therapy (HRT) | Active comparator | 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. Receives: Drug: Hormone Replacement Therapy (HRT) |
| Sleep Hygiene | Sham comparator | 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. Receives: Behavioral: Sleep Hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Insomnia Severity
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.
Measured: Week 10
Secondary outcomes (3)
Improvement in Climacteric Syndrome
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.
Measured: Week 10
Changes in bio-functional age
Change from baseline in biofunctional status (i.e. differences between chronological age and biofunctional age).
Measured: Week 10
Changes in maladaptive sleep-related cognitions
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.
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start1 Jan 2026
- Primary completion1 Jul 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Petra Stute, Prof., Principal investigator, University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497894
- Sponsor's protocol ID
- 2023-00209
- Other IDs
- 2023
- Status last verified
- Jan 2026
- First submitted
- 4 Jul 2024
- Last updated
- 13 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pavicic E, Stute P, Rudzik F, Urech A, Lozza-Fiacco S. 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 for the treatment of insomnia: study protocol. Trials. 2025 Dec 30;27(1):94. doi: 10.1186/s13063-025-09366-9.
PubMed 41462320
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06497894
- Acronym / sponsor ID
- 2023-00209
- Keywords
- Perimenopause, Insomnia, Cognitive Behavioral Therapy, Hormone Replacement Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy for insomnia (CBT-I) | Experimental | Behavioral: Cognitive Behavioural 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. |
| Hormone Replacement Therapy (HRT) | Active comparator | Drug: 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. |
| Sleep Hygiene | Sham comparator | Behavioral: Sleep HygieneParticipants 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. |
Who may qualify
- Ages
- 45 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioural Therapy for Insomnia (CBT-I)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. | Behavioural | Cognitive Behavioral Therapy for insomnia (CBT-I) |
| Hormone Replacement Therapy (HRT)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. | Drug | Hormone Replacement Therapy (HRT) |
| Sleep HygieneSleep 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. | Behavioural | Sleep Hygiene |
Primary outcome
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.
3 secondary outcomes
Improvement in Climacteric Syndrome
Time frame: Week 10
Changes in bio-functional age
Time frame: Week 10
Changes in maladaptive sleep-related cognitions
Time frame: Week 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Derived from this study: PubMed 41462320Pavicic E, Stute P, Rudzik F, Urech A, Lozza-Fiacco S. 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 for the treatment of insomnia: study protocol. Trials. 2025 Dec 30;27(1):94. doi: 10.1186/s13063-025-09366-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Petra Stute, Prof. principal investigator
University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cognitive Behavioural Therapy for Insomnia (CBT-I), Hormone Replacement Therapy (HRT) and Sleep Hygiene in people with Insomnia and Menopause, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Petra Stute, Prof. (+41 31 632 1010, petra.stute@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of Insomnia Severity (time frame: Week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06497894, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.