Insomnia DisorderSUPNCT06669507
The Sleep Clinic Outcome and Practice Study
A study testing Chronotherapy and Cognitive Behavioral Therapy for Insomnia in people with Insomnia Disorder and Circadian Rhythm Sleep Disorder, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
The goal of this clinical trial is to explore the outcome and practice treatment for sleep-wake disturbances in a Sleep Clinic. The main questions it aims to answer are: What is the practice (timing and duration of treatment components) of sleep-wake disturbance treatment? What is the treatment effect of sleep-wake… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insomnia Disorder, Circadian Rhythm Sleep Disorder
- What is being tested?
- Chronotherapy and Cognitive Behavioral Therapy for Insomnia
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,400 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2025to 31 Dec 2030
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Referred to the Sleep Clinic at St. Olavs Hospital for an assessment of a sleep-wake disruption.
- Age >= 18 years.
- Willing and able to provide written informed consent.
- Meeting the diagnostic criteria for at least one of the following disorders: F51.0 Insomnia disorder or G47.2 Sleep-wake rhythm disorders, considered being either: Delayed sleep-wake phase disorder, Advanced sleep-wake phase disorder, Non-24-hour sleep-wake disorder or Irregular sleep-wake disorder
- Desire non-pharmacological sleep treatment
Who cannot join
- Individuals working night shifts or that otherwise have external conditions that result in inadequate sleep opportunity, such as caring for an infant or does not have permanent housing etc.
- Individuals being blind
- Individuals being psychotic
- Individuals having epilepsy
- Individuals having an ongoing substance abuse
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Sleep Clinic, St Olavs Hospital
Trondheim, 7012
Knut Langsrud, MD/PhD, knut.langsrud@stolav.no
About this study
Official title: The Sleep Clinic Outcome and Practice Study: The SUP-study
The goal of this clinical trial is to explore the outcome and practice treatment for sleep-wake disturbances in a Sleep Clinic. The main questions it aims to answer are:
- What is the practice (timing and duration of treatment components) of sleep-wake disturbance treatment?
- What is the treatment effect of sleep-wake disturbance treatment.
Participants will receive treatment as usual by consultations with a trained psychiatrist or psychologist and will be asked to fill out self-reporting questionnaires and sleep diaries.
Read the detailed description
Background: Sleep-wake disturbances including insomnia disorder and sleep-wake rhythm disorders disables many aspects of life and is highly prevalent. As one of few treatment options for sleep-wake disturbances, the Sleep Clinic at St. Olavs Hospital offers clinical assessments and treatment for this patient group in Norway. Although the treatment of insomnia disorder is well-described and recommended, there is still a major subgroup that to not benefit from the treatment. Additionally, treatment and outcome of sleep-wake rhythm disorders is little described in clinical settings. A study of clinical practice and outcomes of the treatments in the Sleep Clinic, would give the possibility to illuminate these knowledge gaps.
Aim: Describe the practice (timing and duration) and outcomes of the sleep treatments 1) Cognitive Behavioral Therapy for Insomnia and 2) Chronotherapy for sleep-wake rhythm disorders at the Sleep Clinic at St. Olavs Hospital.
Method: All patients referred to the Sleep Clinic will be asked to participate before the first consultation with a clinician. Patients will be clinically assessed, diagnosed and given treatment as usual. Main outcomes will be self-report questionnaires at treatment termination and the use, timing and duration of specific sleep treatment components logged by the clinician during treatment.
Potential impact: The findings from this research project provides possibilities to improve treatment for sleep-wake disturbances by tailoring the treatment different to respective subgroups. The findings will also contribute to novel knowledge on how to treat patients with sleep-wake rhythm disorders and to what degree they benefit from the treatment in a sleep clinic.
- Conditions
- Insomnia Disorder, Circadian Rhythm Sleep Disorder
- Being tested
- Chronotherapy, Cognitive Behavioral Therapy for Insomnia
- Keywords
- Insomnia Disorder, Circadian Rhythm Sleep Disorder, Sleep treatment, CBT-I, Chronotherapy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChronotherapyBehavioural
- The effect of light exposure follows a phase-response curve where circadian phase advancement is strongest in the biological morning, whereas light in the biological evening/night may lead to a phase delay. Light therapy is provided by 30 min light exposure using 10 000 lux light boxes.
- Melatonin 3 milligram is prescribed in tablet forms (not depot), usually 12 hours before the planned rise time.
- Additionally, blue-light-blocking glasses are used to block light exposure at night, which has been found to advance circadian rhythms. Patients are advised to wear their blue-blocking glasses 12 hours before rise time.
Which chronotherapeutic interventions that are used, is considered individually by the clinicians in the Sleep Clinic, but often all three treatment components are used at the same time. Duration of chronotherapy given in the Sleep Clinic vary from 4 to 8 consultations over 1 to 4 months depending on the patients' needs and progress during treatment.
Cognitive Behavioral Therapy for InsomniaBehavioural
Also called CBT-I
All participants will receive treatment as usual. CBT-I has several components and consists of the following interventions including psychoeducation about sleep: sleep hygiene, sleep restriction therapy, stimulus control, and challenging beliefs and perceptions of sleep. Special emphasis is placed on providing a rationale for behavior change as a primary means of improving sleep as well as addressing dysfunctional beliefs the patients may hold about sleep. During treatment, tapering sleep medication is not necessary. However, if the patients are motivated to do so, this is discussed and a plan for tapering is provided. Treatment duration is typically between 4 to 8 consultations over 1 to 4 months depending on the patients' needs and progress during treatment.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | Other | All patients referred to the Sleep Clinic and that is considered eligible and has a signed consent will be included in the study. Receives: Behavioral: Chronotherapy; Behavioral: Cognitive Behavioral Therapy for Insomnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep treatment practice
Timing and duration of sleep treatment componements
Measured: Through study completion, an average of 8 weeks.
Sleep treatment outcome
- Insomnia Severity Index for insomnia disorder
- Insomnia Severity Index with additional question for sleep-wake rhythm disorders
Measured: Through study completion, an average of 8 weeks.
Secondary outcomes (1)
Testing the effectiveness of sleep treatment outcomes in different modes of treatment delivery
- Group versus individual delivery of sleep treatment.
- Telemedicine versus face-to-face delivery of sleep treatment
Measured: Through study completion, an average of 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start1 Jan 2025
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Non-randomized single-arm treatment study with treatment as usual
- Masking
- None (open label)
- Enrolment
- 3,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Knut Langsrud, PhD/MD, Study director, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669507
- Sponsor's protocol ID
- 710756
- Acronym
- SUP
- Status last verified
- Jul 2026
- First submitted
- 28 Oct 2024
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD outside the research team in Trondheim.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sleep Clinic Outcome and Practice Study: The SUP-study
- ClinicalTrials.gov ID
- NCT06669507
- Acronym / sponsor ID
- SUP / 710756
- Conditions
- Insomnia Disorder, Circadian Rhythm Sleep Disorder
- Keywords
- Insomnia Disorder, Circadian Rhythm Sleep Disorder, Sleep treatment, CBT-I, Chronotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,400 participants (estimated)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 1 Nov 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 this clinical trial is to explore the outcome and practice treatment for sleep-wake disturbances in a Sleep Clinic. The main questions it aims to answer are:
- What is the practice (timing and duration of treatment components) of sleep-wake disturbance treatment?
- What is the treatment effect of sleep-wake disturbance treatment.
Participants will receive treatment as usual by consultations with a trained psychiatrist or psychologist and will be asked to fill out self-reporting questionnaires and sleep diaries.
Detailed description
Background: Sleep-wake disturbances including insomnia disorder and sleep-wake rhythm disorders disables many aspects of life and is highly prevalent. As one of few treatment options for sleep-wake disturbances, the Sleep Clinic at St. Olavs Hospital offers clinical assessments and treatment for this patient group in Norway. Although the treatment of insomnia disorder is well-described and recommended, there is still a major subgroup that to not benefit from the treatment. Additionally, treatment and outcome of sleep-wake rhythm disorders is little described in clinical settings. A study of clinical practice and outcomes of the treatments in the Sleep Clinic, would give the possibility to illuminate these knowledge gaps.
Aim: Describe the practice (timing and duration) and outcomes of the sleep treatments 1) Cognitive Behavioral Therapy for Insomnia and 2) Chronotherapy for sleep-wake rhythm disorders at the Sleep Clinic at St. Olavs Hospital.
Method: All patients referred to the Sleep Clinic will be asked to participate before the first consultation with a clinician. Patients will be clinically assessed, diagnosed and given treatment as usual. Main outcomes will be self-report questionnaires at treatment termination and the use, timing and duration of specific sleep treatment components logged by the clinician during treatment.
Potential impact: The findings from this research project provides possibilities to improve treatment for sleep-wake disturbances by tailoring the treatment different to respective subgroups. The findings will also contribute to novel knowledge on how to treat patients with sleep-wake rhythm disorders and to what degree they benefit from the treatment in a sleep clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-randomized single-arm treatment study with treatment as usual
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | Other | Behavioral: Chronotherapy, Behavioral: Cognitive Behavioral Therapy for InsomniaAll patients referred to the Sleep Clinic and that is considered eligible and has a signed consent will be included in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Referred to the Sleep Clinic at St. Olavs Hospital for an assessment of a sleep-wake disruption.
- Age >= 18 years.
- Willing and able to provide written informed consent.
- Meeting the diagnostic criteria for at least one of the following disorders: F51.0 Insomnia disorder or G47.2 Sleep-wake rhythm disorders, considered being either: Delayed sleep-wake phase disorder, Advanced sleep-wake phase disorder, Non-24-hour sleep-wake disorder or Irregular sleep-wake disorder
- Desire non-pharmacological sleep treatment
Key exclusion criteria (5 listed)
- Individuals working night shifts or that otherwise have external conditions that result in inadequate sleep opportunity, such as caring for an infant or does not have permanent housing etc.
- Individuals being blind
- Individuals being psychotic
- Individuals having epilepsy
- Individuals having an ongoing substance abuse
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 |
|---|---|---|
| Chronotherapy1. The effect of light exposure follows a phase-response curve where circadian phase advancement is strongest in the biological morning, whereas light in the biological evening/night may lead to a phase delay. Light therapy is provided by 30 min light exposure using 10 000 lux light boxes. 2. Melatonin 3 milligram is prescribed in tablet forms (not depot), usually 12 hours before the planned rise time. 3. Additionally, blue-light-blocking glasses are used to block light exposure at night, which has been found to advance circadian rhythms. Patients are advised to wear their blue-blocking glasses 12 hours before rise time. Which chronotherapeutic interventions that are used, is considered individually by the clinicians in the Sleep Clinic, but often all three treatment components are used at the same time. Duration of chronotherapy given in the Sleep Clinic vary from 4 to 8 consultations over 1 to 4 months depending on the patients' needs and progress during treatment. | Behavioural | Treatment as usual |
| Cognitive Behavioral Therapy for InsomniaAlso: CBT-IAll participants will receive treatment as usual. CBT-I has several components and consists of the following interventions including psychoeducation about sleep: sleep hygiene, sleep restriction therapy, stimulus control, and challenging beliefs and perceptions of sleep. Special emphasis is placed on providing a rationale for behavior change as a primary means of improving sleep as well as addressing dysfunctional beliefs the patients may hold about sleep. During treatment, tapering sleep medication is not necessary. However, if the patients are motivated to do so, this is discussed and a plan for tapering is provided. Treatment duration is typically between 4 to 8 consultations over 1 to 4 months depending on the patients' needs and progress during treatment. | Behavioural | Treatment as usual |
Primary outcome
Sleep treatment practice
Time frame: Through study completion, an average of 8 weeks.
Timing and duration of sleep treatment componements
Sleep treatment outcome
Time frame: Through study completion, an average of 8 weeks.
1. Insomnia Severity Index for insomnia disorder 2. Insomnia Severity Index with additional question for sleep-wake rhythm disorders
1 secondary outcome
Testing the effectiveness of sleep treatment outcomes in different modes of treatment delivery
Time frame: Through study completion, an average of 8 weeks.
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 20 Jul 2026.
- Individual participant dataSharing planned: No. No plan to share IPD outside the research team in Trondheim.
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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.
Knut Langsrud, PhD/MD study director
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chronotherapy and Cognitive Behavioral Therapy for Insomnia in people with Insomnia Disorder and Circadian Rhythm Sleep Disorder, run by St. Olavs Hospital at 1 site in Norway.
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 5 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 20 Jul 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 Norway. 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 Knut Langsrud, PhD/MD (73864500, knut.langsrud@stolav.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep treatment practice (time frame: Through study completion, an average of 8 weeks.). The study lists 2 primary outcomes in all. 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 20 Jul 2026.