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临床试验/NCT06669507
NCT06669507招募中不适用

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

St. Olavs Hospital2 个研究点 分布在 1 个国家目标入组 3,400 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
3,400
试验地点
2
主要终点
Sleep treatment practice

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Treatment as usual

Other

All patients referred to the Sleep Clinic and that is considered eligible and has a signed consent will be included in the study.

干预措施: Chronotherapy (Behavioral)

Treatment as usual

Other

All patients referred to the Sleep Clinic and that is considered eligible and has a signed consent will be included in the study.

干预措施: Cognitive Behavioral Therapy for Insomnia (Behavioral)

结局指标

主要结局

Sleep treatment practice

时间窗: Through study completion, an average of 8 weeks.

Timing and duration of sleep treatment componements

Sleep treatment outcome

时间窗: Through study completion, an average of 8 weeks.

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

次要结局

  • Testing the effectiveness of sleep treatment outcomes in different modes of treatment delivery(Through study completion, an average of 8 weeks.)

研究者

发起方
St. Olavs Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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