ClinicalTrials.Veeva

Menu

The Sleep Clinic Outcome and Practice Study (SUP)

S

St. Olavs Hospital

Status

Enrolling

Conditions

Circadian Rhythm Sleep Disorder
Insomnia Disorder

Treatments

Behavioral: Chronotherapy
Behavioral: Cognitive Behavioral Therapy for Insomnia

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

3,400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

3,400 participants in 1 patient group

Treatment as usual
Other group
Description:
All patients referred to the Sleep Clinic and that is considered eligible and has a signed consent will be included in the study.
Treatment:
Behavioral: Cognitive Behavioral Therapy for Insomnia
Behavioral: Chronotherapy

Trial documents
2

Trial contacts and locations

1

Loading...

Central trial contact

Cecilie Vestergaard, MD; Knut Langsrud, PhD/MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems