Nebula Study: Comparison of Sleep Screener Apps and Home Sleep Apnea Tests to Polysomnography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- AHI value. Clinical decision for treatment output (Y to CPAP or N to CPAP) of Screener apps and HSAT compared to PSG.
研究概览
简要总结
This is a prospective, unblinded, open-label, single group study. All subjects will undergo concurrent screener app, HSAT testing, and 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
- Screening
- 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
- 是
入选标准
- •Participant is 18 years of age or older
- •Participant is willing to provide informed consent
- •Participant is willing to participate in all study related procedures
排除标准
- •Unable to cease PAP therapy during PSG (if currently using)
- •Requires use of oxygen therapy during sleep
- •Diagnosis of untreated clinically relevant sleep disorder (other than SDB)
- •Participant is unsuitable to participate in the study in the opinion of the investigator
- •Participant has a permanent pacemaker, sustained non-sinus cardiac arrhythmias, and/or takes alpha blocker or short acting nitrate medication.
研究组 & 干预措施
Concurrent PSG, HSAT, and Screener App Test
Participants will undergo a single night baseline PSG test with concurrent HSAT tests as well as non-contact screening mobile apps through a smartphone.
干预措施: PSG (Diagnostic Test)
Concurrent PSG, HSAT, and Screener App Test
Participants will undergo a single night baseline PSG test with concurrent HSAT tests as well as non-contact screening mobile apps through a smartphone.
干预措施: Home Sleep Apnea Test with FDA cleared devices (Diagnostic Test)
Concurrent PSG, HSAT, and Screener App Test
Participants will undergo a single night baseline PSG test with concurrent HSAT tests as well as non-contact screening mobile apps through a smartphone.
干预措施: Non-Contact Screening App (Other)
结局指标
主要结局
AHI value. Clinical decision for treatment output (Y to CPAP or N to CPAP) of Screener apps and HSAT compared to PSG.
时间窗: Day 1
The PSG clinical decision for treatment is defined as AHI≥15. Screener apps and HSATs provide AHI values that will be used for comparison.
次要结局
- OSA severity categories (normal, mild, moderate, severe) of Screnner apps and HSAT compared to PSG.(Day 1)