Health TrialsbyHealthPanel

The Sleep Clinic Outcome and Practice Study

ConditionsInsomnia DisorderCircadian Rhythm Sleep Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt. Olavs Hospital

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

3,400 Participants
are divided into 1 treatment group
Group A: Treatment as usualOther 2 interventions

Trial outcomes

Primary outcomes

1

Sleep treatment practice

Timing and duration of sleep treatment componements

Time frame
Through study completion, an average of 8 weeks.
2

Sleep treatment outcome

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

Time frame
Through study completion, an average of 8 weeks.

Secondary outcomes

1

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

1. Group versus individual delivery of sleep treatment. 2. Telemedicine versus face-to-face delivery of sleep treatment

Time frame
Through study completion, an average of 8 weeks.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

St. Olavs Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now