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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chronotherapy | Behavioral |
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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep treatment practice | Timing and duration of sleep treatment componements | Through study completion, an average of 8 weeks. |
| Sleep treatment outcome |
| Through study completion, an average of 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Testing the effectiveness of sleep treatment outcomes in different modes of treatment delivery |
| Through study completion, an average of 8 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Knut Langsrud, PhD/MD | Contact | 73864500 | knut.langsrud@stolav.no | |
| Cecilie Vestergaard, MD | Contact | +4741672197 | cecilie.l.vestergaard@ntnu.no |
| Name | Affiliation | Role |
|---|---|---|
| Knut Langsrud, PhD/MD | St. Olavs Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep Clinic, St Olavs Hospital | Recruiting | Trondheim | 7012 | Norway |
No plan to share IPD outside the research team in Trondheim.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 10, 2024 | Oct 29, 2024 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 10, 2024 | Oct 29, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D020178 | Sleep Disorders, Circadian Rhythm |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D019454 | Chronotherapy |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Non-randomized single-arm treatment study with treatment as usual
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| Cognitive Behavioral Therapy for Insomnia | Behavioral | 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. |
|
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| D001523 |
| Mental Disorders |
| D021081 | Chronobiology Disorders |
| D009784 | Occupational Diseases |