The Sleep Clinic Outcome and Practice Study

Not Applicable

Not yet recruiting

• Conditions: Insomnia Disorder; Circadian Rhythm Sleep Disorder

• Registration Number: NCT06669507
• Lead Sponsor: St. Olavs Hospital

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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-10-28
• Study First Submitted QC: 2024-10-30
• Last Update Submitted: 2024-10-30
• Study First Posted: 2024-11-01
• Last Update Posted: 2024-11-01
• Study Start: 2025-01-01
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Sleep treatment practice	Through study completion, an average of 8 weeks.	Timing and duration of sleep treatment componements
Sleep treatment outcome	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

Secondary Outcome Measures

Name	Time	Method
Testing the effectiveness of sleep treatment outcomes in different modes of treatment delivery	Through study completion, an average of 8 weeks.	1. Group versus individual delivery of sleep treatment.; 2. Telemedicine versus face-to-face delivery of sleep treatment

Trial Locations

Locations (1)

Sleep Clinic, St Olavs Hospital; 🇳🇴 Trondheim, Norway