Meditation-Relaxation (MR Therapy) for Sleep Paralysis: A Pilot Study in Patients With Narcolepsy
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
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.
研究组 & 干预措施
MR therapy
MR therapy is a psychological treatment for SP, comprised of the following steps applied directly during the attack: Step I: Reappraisal of the meaning of the attack; Step II: psychological and emotional distancing; Step III: inward focused-attention meditation; Step IV: Muscle relaxation.
干预措施: MR therapy. (Behavioral)
Control intervention
The control intervention was identical, except participants engaged in deep breathing; entailing slow deep breaths, while repeatedly counting from 1-10. This is an active control (breathing-distraction exercise) rather than a placebo.
干预措施: breathing-distraction exercise (Behavioral)
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.)