The Sleep Clinic Outcome and Practice Study

NCT06669507 | Recruiting

• 1 other identifier: 710756
• Study Type: interventional
• Target: 3,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia Disorder; Circadian Rhythm Sleep Disorder

Keywords

Insomnia Disorder; Circadian Rhythm Sleep Disorder; Sleep treatment; CBT-I; Chronotherapy

Outcome Measures

Primary Outcomes (2)

• Sleep treatment practice

  Timing and duration of sleep treatment componements

  Through study completion, an average of 8 weeks.

• Sleep treatment outcome

  1. Insomnia Severity Index for insomnia disorder 2. Insomnia Severity Index with additional question for sleep-wake rhythm disorders

  Through study completion, an average of 8 weeks.

Secondary Outcomes (1)

• Testing the effectiveness of sleep treatment outcomes in different modes of treatment delivery

  Through study completion, an average of 8 weeks.

Study Arms (1)

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.

Behavioral: Chronotherapy; Behavioral: Cognitive Behavioral Therapy for Insomnia

Interventions

Chronotherapy BEHAVIORAL

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.

Treatment as usual

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.

Also known as: CBT-I

Treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Olavs Hospital: lead

Study Sites (1)

Sleep Clinic, St Olavs Hospital

Trondheim, 7012, Norway

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Disorders, Circadian Rhythm

Interventions

Chronotherapy; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Chronobiology Disorders; Occupational Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Knut Langsrud, PhD/MD

  St. Olavs Hospital

  STUDY DIRECTOR

Central Study Contacts

Knut Langsrud, PhD/MD

CONTACT

73864500; knut.langsrud@stolav.no

Cecilie Vestergaard, MD

CONTACT

+4741672197; cecilie.l.vestergaard@ntnu.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-randomized single-arm treatment study with treatment as usual

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 1, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)