Insomnia DisordersSLEEPwindowNCT06767137
Comparative Efficacy of BRT and CBT-I for Insomnia
A study testing Cognitive behavioral therapy for insomnia (CBT-I) and Bedtime restriction (BRT) in people with Insomnia Disorders and Insomnia Disorder, run by Christoph Nissen at 2 sites in Switzerland.
Trial summary
This study evaluates two behavioral treatments for patients with insomnia disorder: Bedtime Restriction Therapy (BRT) and Cognitive Behavioral Therapy for Insomnia (CBT-I). Both therapies aim to improve the clinical symptomatology of insomnia by teaching participants techniques to better manage their sleep schedule… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Insomnia Disorders, Insomnia Disorder, Insomnia
- What is being tested?
- Cognitive behavioral therapy for insomnia (CBT-I) and Bedtime restriction (BRT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 10 Mar 2025to 1 Nov 2027
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must meet DSM-5 criteria for insomnia disorder.
- Adults aged 18 to 80 years
- Capable of giving written informed consent.
- Sufficient fluency in the study site's language (i.e., German or French) to understand all study-related information.
Who cannot join
- Unstable, progressive, or degenerative medical condition
- Acute pain or poorly managed chronic pain
- Suicidality
- Uncontrolled psychiatric condition requiring treatment outside of study
- Alcohol or drug abuse or dependency
- Diagnosis of psychosis, bipolar disorder, autism, borderline personality disorder, or antisocial personality disorder
Show all 14Show fewer
- Clinical evidence of sleep disorders other than insomnia (e.g., sleep apnea, restless legs, periodic limb movements in sleep, parasomnia)
- Evidence of intellectual disability
- Regular intake of benzodiazepines (BZD) or benzodiazepine receptor agonists (BZDRA)
- Alteration of medication within 4 weeks prior to study treatment or planned alteration during the trial period (stable medication except BZD or BZDRA does not lead to exclusion)
- Current other psychotherapy for insomnia
- Known pregnancy or breastfeeding
- Inability to comply with study procedure
- Insufficient fluency in German or French to complete the study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
Universität Bern, Psychotherapeutische Praxisstelle
Bern, Canton of Bern, 3012
Thomas Berger, Prof. Dr., +4158 944 03 00, sleepwindow@unige.ch
- Recruiting
Service des specialités psychiatriques, Hôpitaux universitaires de Genève
Geneva, Canton of Geneva, 1201
Elisabeth Hertenstein, PD, PhD, +4158 944 03 00, sleepwindow@unige.ch
About this study
Official title: Comparative Efficacy of Bedtime Restriction Therapy and Cognitive Behavioral Therapy for Insomnia - a Randomized Controlled Non-inferiority Trial
This study evaluates two behavioral treatments for patients with insomnia disorder: Bedtime Restriction Therapy (BRT) and Cognitive Behavioral Therapy for Insomnia (CBT-I). Both therapies aim to improve the clinical symptomatology of insomnia by teaching participants techniques to better manage their sleep schedule and habits. BRT is a simpler and shorter therapy focused on aligning the time spent in bed with reported sleep time. CBT-I includes additional components such as relaxation techniques and cognitive exercises. The study will compare these treatments to see if BRT is as effective as CBT-I in improving the clinical symptomatology of insomnia.
- Conditions
- Insomnia Disorders, Insomnia Disorder, Insomnia, Insomnia Chronic, Insomnia, Primary, Insomnia, Nonorganic
- Being tested
- Cognitive behavioral therapy for insomnia (CBT-I), Bedtime restriction (BRT)
- Keywords
- insomnia, cognitive behavioral therapy, bedtime restriction, sleep restriction
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy for insomnia (CBT-I)Behavioural
Cognitive Behavioral Therapy for Insomnia (CBT-I) is a gold-standard, evidence-based treatment combining techniques to improve the clinical symptomatology of insomnia. Delivered in six 90-minute group sessions over six weeks, it includes: sleep education (i.e. understanding sleep mechanisms and influencing factors), bedtime restriction (i.e. aligning bedtimes with reported sleep duration), stimulus control (i.e. getting out of bed when unable to sleep), cognitive therapy (i.e. addressing dysfunctional sleep beliefs), relaxation techniques (i.e. using methods like progressive muscle relaxation).
Bedtime restriction (BRT)Behavioural
Bedtime Restriction Therapy (BRT): A behavioral intervention aimed at improving the clinical symptomatology of insomnia by aligning time spent in bed with reported sleep duration. Participants attend four 60-minute group therapy sessions over six weeks. The intervention includes: setting individualized sleep windows based on sleep diaries, regular adjustment of sleep schedules to enhance sleep pressure, group discussions to address implementation challenges and maintain motivation.
BRT focuses exclusively on bed time restriction without additional cognitive or relaxation components, making it a simplified, resource-efficient approach to treating insomnia.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavioral therapy for insomnia (CBT-I) | Experimental | Not described Receives: Behavioral: Cognitive behavioral therapy for insomnia (CBT-I) |
| Bedtime restriction (BRT) | Experimental | Not described Receives: Behavioral: Bedtime restriction (BRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI) summary scores
Measured: Baseline (T0) to 6 weeks (T1), 3 months (T2), and 6 months (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start10 Mar 2025 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia DisordersStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christoph Nissen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christoph Nissen, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767137
- Sponsor's protocol ID
- 2024-01324
- Acronym
- SLEEPwindow
- Status last verified
- Feb 2025
- First submitted
- 6 Jan 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Bedtime Restriction Therapy and Cognitive Behavioral Therapy for Insomnia - a Randomized Controlled Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT06767137
- Acronym / sponsor ID
- SLEEPwindow / 2024-01324
- Conditions
- Insomnia Disorders, Insomnia Disorder, Insomnia, Insomnia Chronic, Insomnia, Primary, Insomnia, Nonorganic
- Keywords
- insomnia, cognitive behavioral therapy, bedtime restriction, sleep restriction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Christoph NissenUniversity, hospital or other
- Study start
- 10 Mar 2025 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 9 Jan 2025 (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.
This study evaluates two behavioral treatments for patients with insomnia disorder: Bedtime Restriction Therapy (BRT) and Cognitive Behavioral Therapy for Insomnia (CBT-I). Both therapies aim to improve the clinical symptomatology of insomnia by teaching participants techniques to better manage their sleep schedule and habits. BRT is a simpler and shorter therapy focused on aligning the time spent in bed with reported sleep time. CBT-I includes additional components such as relaxation techniques and cognitive exercises. The study will compare these treatments to see if BRT is as effective as CBT-I in improving the clinical symptomatology of insomnia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioral therapy for insomnia (CBT-I) | Experimental | Behavioral: Cognitive behavioral therapy for insomnia (CBT-I) |
| Bedtime restriction (BRT) | Experimental | Behavioral: Bedtime restriction (BRT) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must meet DSM-5 criteria for insomnia disorder.
- Adults aged 18 to 80 years
- Capable of giving written informed consent.
- Sufficient fluency in the study site's language (i.e., German or French) to understand all study-related information.
Key exclusion criteria (14 listed)
- Unstable, progressive, or degenerative medical condition
- Acute pain or poorly managed chronic pain
- Suicidality
- Uncontrolled psychiatric condition requiring treatment outside of study
- Alcohol or drug abuse or dependency
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 behavioral therapy for insomnia (CBT-I)Cognitive Behavioral Therapy for Insomnia (CBT-I) is a gold-standard, evidence-based treatment combining techniques to improve the clinical symptomatology of insomnia. Delivered in six 90-minute group sessions over six weeks, it includes: sleep education (i.e. understanding sleep mechanisms and influencing factors), bedtime restriction (i.e. aligning bedtimes with reported sleep duration), stimulus control (i.e. getting out of bed when unable to sleep), cognitive therapy (i.e. addressing dysfunctional sleep beliefs), relaxation techniques (i.e. using methods like progressive muscle relaxation). | Behavioural | Cognitive behavioral therapy for insomnia (CBT-I) |
| Bedtime restriction (BRT)Bedtime Restriction Therapy (BRT): A behavioral intervention aimed at improving the clinical symptomatology of insomnia by aligning time spent in bed with reported sleep duration. Participants attend four 60-minute group therapy sessions over six weeks. The intervention includes: setting individualized sleep windows based on sleep diaries, regular adjustment of sleep schedules to enhance sleep pressure, group discussions to address implementation challenges and maintain motivation. BRT focuses exclusively on bed time restriction without additional cognitive or relaxation components, making it a simplified, resource-efficient approach to treating insomnia. | Behavioural | Bedtime restriction (BRT) |
Primary outcome
Insomnia Severity Index (ISI) summary scores
Time frame: Baseline (T0) to 6 weeks (T1), 3 months (T2), and 6 months (T3)
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 17 Feb 2025.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy for insomnia (CBT-I) and Bedtime restriction (BRT) in people with Insomnia Disorders and Insomnia Disorder, run by Christoph Nissen at 2 sites 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 4 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 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Elisabeth Hertenstein, PD, PhD (+41589440300, sleepwindow@unige.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) summary scores (time frame: Baseline (T0) to 6 weeks (T1), 3 months (T2), and 6 months (T3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2025.