RecruitingNot ApplicableNCT06669507

The Sleep Clinic Outcome and Practice Study

The Sleep Clinic Outcome and Practice Study: The SUP-study


Sponsor

St. Olavs Hospital

Enrollment

3,400 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Chronotherapy and Cognitive Behavioral Therapy for Insomnia for people with circadian rhythm sleep disorder and insomnia disorder. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALChronotherapy

1. 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.

BEHAVIORALCognitive Behavioral Therapy for Insomnia

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.


Locations(1)

Sleep Clinic, St Olavs Hospital

Trondheim, Norway

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NCT06669507


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