PMP-300E: Validation of Portable Monitoring Device PMP-300E for Identification of Obstructive Sleep Apnea.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- AHI
研究概览
简要总结
Validation of Portable Monitoring Device PMP-300E for Identification of Obstructive Sleep Apnea.
详细描述
The purpose of the study is to validate an Obstructive Sleep Apnea portable monitoring device, PMP-300E. Validating process compared data collected by PMP-300E with data collected from in-lab polysomnography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Age 18 and over.
- •Require a sleep diagnostic study by physician's order.
- •Able and willing to provide written informed consent.
- •Able to speak and read English.
排除标准
- •Exclusion Criteria:
- •Participation in another interventional research study within the last 30 days.
- •Unstable medical or psychiatric conditions that would interfere with the demands of the study or the ability to commit to follow-up assessment. Examples include unstable congestive heart failure, neuromuscular disease, cancer, and renal failure.
- •Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate or severe COPD or other pulmonary disorders, or any condition with an elevation of arterial carbon dioxide levels (> 45 mmHg) while awake or participants qualifying for oxygen therapy (arterial saturation 88% for more than five minutes).
- •Consumption of ethanol more than 4 nights per week. (CAGE criteria)
- •Use of recreational drug within the past 12 months.
- •Women who are pregnant or currently lactating.
研究组 & 干预措施
PMP-300E, In-Lab PSG
PMP-300E, A 7-channel (nasal pressure, effort, snoring, SpO2, pulse rate, body position and movement) Level 3 portable monitor (11.2 x 3.3 x 5.5cm, 80g, Pacific Medico Co., LTD) to measure sleep-related breathing will be tested against conventional gold-standard In-Lab Polysomnography (sleep study)
干预措施: PMP-300E (Device)
PMP-300E, In-Lab PSG
PMP-300E, A 7-channel (nasal pressure, effort, snoring, SpO2, pulse rate, body position and movement) Level 3 portable monitor (11.2 x 3.3 x 5.5cm, 80g, Pacific Medico Co., LTD) to measure sleep-related breathing will be tested against conventional gold-standard In-Lab Polysomnography (sleep study)
干预措施: In-lab PSG (Device)
结局指标
主要结局
AHI
时间窗: One night
Apnea-Hypopnea Index (number of events/hour of sleep). Hypopneas scored without EEG arousals.
次要结局
- Apnea Index(One night)
- Oxygen Saturation(One night)
- Hypopnea Index(One night)
研究者
Clete A. Kushida
Principle Investigator
Stanford University