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临床试验/NCT04483310
NCT04483310Unknown不适用

Meditation-Relaxation (MR Therapy) for Sleep Paralysis: A Pilot Study in Patients With Narcolepsy

Azienda Usl di Bologna1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年12月1日最近更新:
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适应症

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
Sleep Paralysis Experiences and Phenomenology Questionnaire (SP-EPQ)
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The aim of the study is to evaluate, with a small-scale pilot study, the efficacy of Meditation Relaxation therapy for Sleep Paralyses in patients with narcolepsy. The study involves two arms, with intervention with Meditation Relaxation therapy or sham over a period of three months.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Narcolepsy (type 1 and 2) based on polysomnography, Multiple Sleep Latency Test [MLST] and CSF hypocretin level testing).
  • •Patients had to have experienced SP at least four times in the last month.

排除标准

  • •Psychiatric comorbidity.

结局指标

主要结局

Sleep Paralysis Experiences and Phenomenology Questionnaire (SP-EPQ)

时间窗: Three months.

The questionnaire addresses the distress associated with SP.

次要结局

  • Daily journal(Three months.)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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