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临床试验/NCT04306835
NCT04306835Unknown不适用

The Impact of Cognitive Behavioral Therapy for Insomnia on CPAP Therapy Use and Drop Outs in Obstructive Sleep Apnea Syndrome Patients With Insomnia.

Universitair Ziekenhuis Brussel2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年10月22日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
The number of drop-outs in patients participating in the study.

研究概览

简要总结

Patients follow the fully standard sleep test according to the normal procedure. This means that they undergo a polysomnography and fill in a questionnaire. If according to the questionnaire, there is insomnia, the patient also receives an intake interview to check whether this is indeed the case. If the patient has both disorders and meets the inclusion and exclusion criteria, they will be asked to sign the informed consent. If the patient agrees, the CPAP-therapy will be started as usual, simultaneously with CGT-i. The latter will last 7 weeks and will cover the following points: psycho-education, sleep restriction and sleep hygiene, cognition, relaxation and relapse prevention. Because of the design of this study (starting CGT-I as soon as possible after the diagnosis of OSAS) and the groups already planned for CBT-I, it is not possible for all participants to participate in group cognitive behavioral therapy, therefore individual sessions were provided for these participants. The patient comes for monitoring at set times.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients, male and female, with an OSAS diagnosed by full polysomnography and insomnia diagnosed by questionnaires.
  • Age between 18 and 75 years
  • Dutch as native language

排除标准

  • Patients younger than 18 years and older than 75 years
  • Patients with a burn-out
  • Patients with restless legs
  • Pregnant woman
  • Patients who work as shift workers
  • Patients with severe psychiatric disorder
  • Patients who take sleep medication, unless it can be reduced and stopped during cognitive behavior therapy
  • Patients with daily alcohol abuse (men > 3 drinks on any day or 14 per week, women > 2 drinks on any day or 7 per week)

结局指标

主要结局

The number of drop-outs in patients participating in the study.

时间窗: 12 weeks

Patiënt who don't use there CPAP anymore.

CPAP habituation in patients participating in the study.

时间窗: 12 weeks

The speed of CPAP habituation is determined by reading the CPAP device.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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