Sleep Clinic, St Olavs Hospital
Trondheim, 7012, Norway
Location status: Recruiting
NCT Number: NCT06669507
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Trondheim, 7012, Norway
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
Time frame: Through study completion, an average of 8 weeks.
Timing and duration of sleep treatment componements
Time frame: Through study completion, an average of 8 weeks.
Time frame: Through study completion, an average of 8 weeks.
Contact information is provided by the study sponsor or research team.
Cecilie Vestergaard, MD
CONTACT
Knut Langsrud, PhD/MD
CONTACT
St. Olavs Hospital
Other
The Sleep Clinic Outcome and Practice Study: The SUP-study
Acronym: SUP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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