The Sleep Clinic Outcome and Practice Study

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Chronotherapy
  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
• Поведенческое 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 medica

Первичные конечные точки

• Sleep treatment practice [Срок оценки: Through study completion, an average of 8 weeks.]
• Sleep treatment outcome [Срок оценки: Through study completion, an average of 8 weeks.]

Вторичные конечные точки (1)

• Testing the effectiveness of sleep treatment outcomes in different modes of treatment delivery [Срок оценки: Through study completion, an average of 8 weeks.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Норвегия · 1 центр

• Sleep Clinic, St Olavs Hospital — Trondheim

Идентификаторы

NCT: NCT06669507 · 710756

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗