The Sleep Clinic Outcome and Practice Study (SUP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Insomnia Disorder; Circadian Rhythm Sleep Disorder
• Intervention / Treatment: Behavioral: Chronotherapy; Behavioral: Cognitive Behavioral Therapy for Insomnia

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 Type: Interventional
• Enrollment (Estimated): 3400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Knut Langsrud, PhD/MD; Phone Number: 73864500; Email: knut.langsrud@stolav.no
• Study Contact Backup: Name: Cecilie Vestergaard, MD; Phone Number: +4741672197; Email: cecilie.l.vestergaard@ntnu.no

Study Locations

• Norway
  • Trondheim, Norway, 7012
    • Recruiting
    • Sleep Clinic, St Olavs Hospital
    • Contact: Knut Langsrud, MD/PhD; Email: knut.langsrud@stolav.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Treatment as usual; 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; 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.; Melatonin 3 milligram is prescribed in tablet forms (not depot), usually 12 hours before the planned rise time.; 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.; Behavioral: Cognitive 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.; Other Names: CBT-I

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep treatment practice	Timing and duration of sleep treatment componements	Through study completion, an average of 8 weeks.
Sleep treatment outcome	Insomnia Severity Index for insomnia disorder; Insomnia Severity Index with additional question for sleep-wake rhythm disorders	Through study completion, an average of 8 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Testing the effectiveness of sleep treatment outcomes in different modes of treatment delivery	Group versus individual delivery of sleep treatment.; Telemedicine versus face-to-face delivery of sleep treatment	Through study completion, an average of 8 weeks.

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Investigators: Study Director: Knut Langsrud, PhD/MD, St. Olavs hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: October 28, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Actual): November 1, 2024

Study Record Updates

• Last Update Posted (Actual): June 24, 2025
• Last Update Submitted That Met QC Criteria: June 18, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Chronotherapy; CBT-I; Insomnia Disorder; Circadian Rhythm Sleep Disorder; Sleep treatment
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Chronobiology Disorders; Occupational Diseases; Parasomnias; Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm
• Other Study ID Numbers: 710756

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD outside the research team in Trondheim.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No