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临床试验/NCT04118816
NCT04118816Unknown不适用

Impact of Sleep-disordered Breathing on Autonomic Regulation in Patients With Prader-Willi Syndrome

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年6月25日最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
Narcolepsy prevalence

研究概览

简要总结

To evaluate autonomic regulation in patients with Prader-Willi syndrome with sleep-disordered breathing.

详细描述

To evaluate the relationship between narcolepsy and sleep-disordered breathing, the natural course of untreated or treated sleep-disordered breathing and its impacts on autonomic regulation in patients with Prader-Willi syndrome with sleep-disordered breathing.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • 7-75 y/o Prader-Willi syndrome patients or healthy subjects
  • can perform polysomnography, multiple sleep latency test
  • orthostatic methods for autonomic function test
  • can perform pulmonary function test.

排除标准

  • less than y/o, or larger then 75 y/o
  • cannot perform polysomnography, multiple sleep latency test
  • cannot orthostatic methods for autonomic function test
  • cannot perform pulmonary function test
  • use of sedatives or drugs affecting autonomic function

结局指标

主要结局

Narcolepsy prevalence

时间窗: 1day

Compare the narcolepsy prevalence amount healthy and Prader-Willi syndrome with or without sleep-disordered breathing

次要结局

  • The natural course and its impact of untreated sleep-disordered breathing on autonomic regulation in patients with Prader-Willi syndrome.(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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