Sleep Apnea Detection and Sleep Staging Using Skiin Wearable Textile Sensors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Accuracy of Skiin system for detection of apnea/hypopnea compared to Polysomnography
研究概览
简要总结
The goal of this observational study is to develop new algorithms to detect apnea and/or hypopnea to provide additional insights to Skiin users and to their circle of care to validate and/or improve the current algorithms of the Skiin system for extraction of biological metrics during sleep based on the Skiin ECG and accelerometry data.
详细描述
Eligible individuals who consent to participate will be asked to wear a Skiin Underwear chest band while going through a polyssomnography test.
- Investigational device
The Skiin underwear chest band is worn at the under-chest level (under the pectoral or breast fold), and is connected to the Skiin Connected Life App (SCLA). The app collects ECG, accelerations, and temperature to generate metrics such as sleep, activity, and other physiological biometrics (resting heart rate, heart rate variability, breathing rate). The investigator will ensure the chest band is worn properly as defined by the vertical line on the band besides the Skiin logo corresponding with the center of the body. 2. Polysomnography
The equipment being used for polysomnography is the Embla Sandman Elite PSG System. In advance to the test, patients receive information about the PSG test procedure and patients are usually instructed to avoid naps and stimulants (i.e., caffeine) during the day of the test. A list of instructions is usually provided to the patient.
Once the patient is ready for bed, the technologists will place sensors on the patient's scalp, temples, chest and legs using a mild adhesive, such as glue or tape. The sensors are connected by wires to a computer (wires are long enough to let the patient move around in bed). A small clip is placed on the finger or ear to monitor the level of oxygen in the blood.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
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
- •Individuals referred to do a polysomnography
- •Diagnosed or suspected obstructive sleep apnea (OSA)
- •18 years old or more
- •Understand and speak English enough to consent
排除标准
- •Pregnant women
- •Implanted defibrillator or pacemaker
- •Absence of a garment fitting the participant's body
- •An open wound or dressing (e.g. band-aid) on a body part that needs to be in contact with the Skiin electrodes
结局指标
主要结局
Accuracy of Skiin system for detection of apnea/hypopnea compared to Polysomnography
时间窗: Over one night, 8 to 12 hours total
Apnea/hypopnea events identified in the Skiin system will be compared to Apnea/hypopnea events identified in the polysomnography system. Data will be categorized as true positive, false positive, false negative to calculate the sensitivity, specificity, PPV, NPV).
次要结局
- Accuracy of Skiin system for estimation of breathing rate compared to Polysomnography(Over one night, 8 to 12 hours total)
- Accuracy of Skiin system for detection of sleep duration compared to Polysomnography(Over one night, 8 to 12 hours total)
- Accuracy of Skiin system for calculation of heart rate variability compared to polysomnography(Over one night, 8 to 12 hours total)
- Accuracy of Skiin system for calculation of resting heart rate compared to Polysomnography(Over one night, 8 to 12 hours total)