Clinical trial NCT06669507: The Sleep Clinic Outcome and Practice Study
Official title: The Sleep Clinic Outcome and Practice Study: The SUP-study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Insomnia Disorder
Circadian Rhythm Sleep Disorder
Keywords: Insomnia Disorder
Circadian Rhythm Sleep Disorder
Sleep treatment
CBT-I
Chronotherapy
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 3400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Non-randomized single-arm treatment study with treatment as usual
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Sleep treatment practice
timeFrame: Through study completion, an average of 8 weeks.
measure: Sleep treatment outcome
timeFrame: Through study completion, an average of 8 weeks.
Secondary outcomes:
measure: Testing the effectiveness of sleep treatment outcomes in different modes of treatment delivery
timeFrame: Through study completion, an average of 8 weeks.
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Sleep Clinic, St Olavs Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Knut Langsrud, PhD/MD
role: STUDY_DIRECTOR
References: