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临床试验/NCT02969551
NCT02969551Unknown不适用

Detection of Airway Obstruction by Manometry in Different Sleep Stages and Comparing it to DISE

Technical University of Munich1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
Detection of obstruction depending of sleep stage

研究概览

简要总结

Patients with OSA receive manometry measurements with Apneagraph (AG) during one night of sleep. All patients are simultaneously evaluated with polysomnography. Patients who are not eligible for CPAP therapy are additionally studied with drug-induced sleep endoscopy (DISE). The frequency and obstructions patterns in different sleep stages are assessed. In addition obstruction patterns detected with AG are compared with DISE examination in the selected cases.

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

入选标准

  • Apnea-Hypopnea-Index (AHI) ≥ 5.

排除标准

  • age <18 years;
  • body mass index (BMI) of >35 kg/m2; active infection;
  • previous oral, head, or neck surgery in the last 3 months; pregnancy; chronic use of alcohol (> 60g ethanol per day or > 150g ethanol per week) or sedatives; illicit drug use;
  • chronic obstructive pulmonary disease.

结局指标

主要结局

Detection of obstruction depending of sleep stage

时间窗: 8

次要结局

  • Comparing the manometry findings to DISE(1 Hour)

研究者

发起方
Technical University of Munich
申办方类型
Other
责任方
Sponsor

研究点 (1)

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