The Sleep Clinic Outcome and Practice Study: The SUP-study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Insomnia Disorder
- Sponsor
- St. Olavs Hospital
- Enrollment
- 3400
- Locations
- 1
- Primary Endpoint
- Sleep treatment practice
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Testing the effectiveness of sleep treatment outcomes in different modes of treatment delivery(Through study completion, an average of 8 weeks.)