跳至主要内容
临床试验/NCT01831583
NCT01831583Unknown不适用

Assessment of a New Photoplethysmographic (PPG) Method and a Pulse Arrival Time Method to Detect Upper Airway Obstruction in Patients With Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) in a Sleep Laboratory

Sotera Wireless, Inc.2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2013年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
15
试验地点
2
主要终点
Measurement of pulse arrival time in patients with obstructive sleep apnea syndrome.

研究概览

简要总结

The goal of this study is to collect raw waveform data for two separate noninvasive methods, both of which may be useful for the assessment of upper airway obstruction.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Patients twenty-one years of age or older

排除标准

  • Patient refusal to participate in study
  • Patients under 21 (twenty-one) years of age,
  • Referring physician's refusal to have his/her patient participate in the study.
  • Patients with cardiac dysrhythmia (arrhythmia), including atrial fibrillation, and frequent premature atrial and/or ventricular contractions.
  • Inability to obtain a Sotera cuff pressure and/or PPG signals

结局指标

主要结局

Measurement of pulse arrival time in patients with obstructive sleep apnea syndrome.

时间窗: 4 - 8 hours

The goal of this study is to collect pulse arrival time data as a means for the assessment of upper airway obstruction.

次要结局

  • Non-invasive Photoplethysmographic (PPG) measurement in patients with obstructive sleep apnea syndrome.(4 - 8 hours)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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