Evaluation of Novel Proprietary Biometric as an Aid in the Screening and Diagnosis of Sleep Breathing Disorders
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Resonea, Inc
- 入组人数
- 83
- 试验地点
- 4
- 主要终点
- Level of agreement between Sleep Breathing Index Score obtained from analysis by the proprietary algorith, and the Apnea-Hypopnea Index (AHI) as obtained by HST, with a cut-off of 15
研究概览
简要总结
Earlier studies suggest that acoustical analysis of snoring sounds can identify obstructive sleep apnea (OSA). The goal of the current study is to refine and validate algorithms for OSA diagnosis.
详细描述
Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) where cessation of breathing occurs during sleep in 9% of middle-aged women and 25% or middle-aged men. Major health issues and risks have been linked to untreated sleep apnea, including drug-resistant hypertension, obesity, congestive heart failure and diabetes.
Patient awareness of this condition is growing, but obtaining adequate data has continuing barriers. The gold standard for sleep testing is the overnight clinical polysomnogram (PSG) where over 20 sensors are attached to a patient and vital signs are monitored and recorded over the course of a 6-8 hour sleep test.
This is a prospective clinical performance study to compare the ability of proprietary algorithms that analyze sleep recordings from smartphones, with FDA cleared Level III home sleep testing (HST) devices, to identify patients with obstructive sleep apnea (OSA).
Consecutive patients referred for home sleep testing (HST) for possible OSA will be offered participation. Participants who provide informed consent will fill out a questionnaire and then proceed with HST in their home. During HST, additional sound recordings will be made with either:
- Android type smartphone with a recording application (app). The phone will be placed on a table 50-100 cm (20-40 inches) from patient's mouth.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 是
入选标准
- •referred for polysomnography (PSG) because of possible obstructive sleep apnea (OSA)
- •owns/possesses a smartphone for use during the study. Must be:
- •Android models running Android OS Samsung Galaxy 5 or later
- •iPhone models running iOS 6 or later
排除标准
- •previous PSG or home sleep testing (HST) confirmation of OSA
- •prior surgery for snoring or OSA
- •medical contraindication of HST, as applicable
- •congnitive impairment that might interfere with obtaining informed consent, or completing Clinical Questionnaire
结局指标
主要结局
Level of agreement between Sleep Breathing Index Score obtained from analysis by the proprietary algorith, and the Apnea-Hypopnea Index (AHI) as obtained by HST, with a cut-off of 15
时间窗: immediate
Level of agreement between the Sleep Breathing Index Score obtained from analysis by the proprietary algorithm, and the Apnea-Hypopnea Index (AHI) as obtained by HST, with a cut-off of 15.
次要结局
未报告次要终点
研究者
Jonathan Freudman
Principal Investigator
Resonea, Inc