A Prospective, Single Center, Open, Equivalence, Two Phase Study Comparing the Sleep Strip OTC™ Accuracy in Screening for Sleep Apnea Syndrome Against the Reference Method, an In-lab Full Night Polysomnographic (PSG) Study.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Paired T-test or signed-rank test; McNemar's test; Sensitivity Analyses
研究概览
简要总结
The primary purpose of this study is to demonstrate the equivalence of the new Sleep Strip OTC(TM) compared to the reference method of an in-lab, attended full-night polysomnographic (PSG) study.
详细描述
A prospective, single center two phase study to evaluate the validity and the predictability of the SleepStrip OTCTM in screening for SAS, as compared to the reference method, an in-lab, full night, attended Polysomnographic (PSG) Study.
The study will consist of two phases:
I: Optimization Phase:will be performed at the Clinic; 20 participants will be enrolled. Each participant will be connected simultaneously to the SleepStrip OTC(TM) and to the standard lab sensors and recorder. This phase is intended to allow SLP to optimize the analysis parameters for optimal performance and will be considered as a pilot phase.
II: Equivalence phase: At least 180 participants will be enrolled. All participants will receive the SleepStrip OTC(TM) for a night test at home, before or after undergoing an independent PSG test at the Sleep lab. Out of 180 participants, at least 26 participants will receive two SleepStrip OTC(TM) devices for two consecutive night tests at home. The remaining participants will receive one SleepStrip OTC(TM) for one night test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Male or Female participants, 18 years of age or older at time of enrollment.
- •Participants who present at the Technion Sleep Disorder Center for a PSG test, and who are willing comply with study procedures.
- •Participants who are willing to sign a Written.
排除标准
- •Participant has a clinically significant untreated chronic disease which may unable him/ her to participate in the study.
- •Participant has facial hair or any other skin problem that may hinder proper application of the device on destined facial area.
- •Participant is suffering from a respiratory-track infection or a runny nose at enrollment.
- •Participant is unable to comprehend the purpose of the study as stated in the participant consent form.
- •Participant is unable to comply with the technical requirements of the study.
研究组 & 干预措施
SleepStrip OTC(TM)
Participants will receive the SleepStrip OTC(TM) for a night (or two) test at home, before or after undergoing an independent PSG test at the Sleep lab. The reading of both methods will be analyzed.
干预措施: SleepStrip OTC(TM) (Device)
结局指标
主要结局
Paired T-test or signed-rank test; McNemar's test; Sensitivity Analyses
时间窗: The data will be analyzed after conclusion of tests of 200 home studies, no later than June 2010
次要结局
未报告次要终点