Validation of a Ring-type Wearable Device for Blood Oxygen Monitoring and Obstructive Sleep Apnea Syndrome Screening in Adult Chinese
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Difference in the mean oxygen saturation
研究概览
简要总结
Study name: Validation of a Ring-type Wearable Device for Blood Oxygen Monitoring and Obstructive Sleep Apnea Syndrome Screening in Adult Chinese.
Objective: 1) To examine the accuracy of blood oxygen monitoring assessed via a ring-type wearable device in comparison to traditional finger clip pulse oximeter; 2) To assess the agreement between the ring-type wearable device and PSG monitor on OSAS screening.
Study design: Clinical diagnostic trial.
Study population: Individuals who are willing to participate in the study and sign the informed consent are considered to be eligible. Specific inclusion criterias include: 1) Agree to receive overnight polysomnography and wear the ring-type device at the same time; 2) At least 18 years old.
Sample size estimation: About 200 participants.
Timeline: Start of subjects' enrollment: Dec 2022; End of subjects' enrollment: Oct 2023; End of study: Oct 2023.
Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.
详细描述
Study name: Validation of a Ring-type Wearable Device for Blood Oxygen Monitoring and Obstructive Sleep Apnea Syndrome Screening in Adult Chinese.
Rationale: Obstructive sleep apnoea syndrome (OSAS) is a common chronic sleep-related breathing disorder characterized by repetitive upper airway collapse during sleep, which causes sleep fragmentation, oxygen desaturation, and excessive daytime sleepiness. Previous studies have identified that OSAS is significantly correlated with the risk of cardiovascular and cerebrovascular diseases. Overnight polysomnography (PSG) is the gold standard for diagnosing OSAS at present. However, PSG monitoring requires professional technicists and a lot of channels, which brings inconvenience to both patients and doctors. Wearable devices are growing in popularity and become comfortable, lightweight and technologically advanced for tracking sleep and daily activity.
Objective: 1) To examine the accuracy of blood oxygen monitoring assessed via a ring-type wearable device in comparison to traditional finger clip pulse oximeter; 2) To assess the agreement between the ring-type wearable device and PSG monitor on OSAS screening.
Study design: Clinical diagnostic trial.
Study population: Individuals who are willing to participate in the study and sign the informed consent are considered to be eligible. Specific inclusion criterias include: 1) Agree to receive overnight polysomnography and wear the ring-type device at the same time; 2) At least 18 years old.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Individuals who are willing to participate in the study and sign the informed consent are considered to be eligible. Specific inclusion criterias include:
- •Agree to receive overnight polysomnography and wear the ring-type device at the same time;
- •At least 18 years old.
排除标准
- •Conditions that influencing overnight polysomnography monitoring, including receiving continuous positive airway pressure treatment and coexisting sleep disorders or insomnia;
- •Participants with cognitive dysfunction who are unable to provide informed consent;
- •Other circumstances that individuals are not appropriate for the study upon the investigator's judgment.
结局指标
主要结局
Difference in the mean oxygen saturation
时间窗: 1 night
次要结局
- Difference in the oxygen desaturation index(1 night)
- Difference in the apnea-hypopnea index(1 night)
- Difference in the lowest oxygen saturation(1 night)
- Agreement between the ring-type wearable device and PSG monitor on OSAS screening(1 night)
- Difference in the hypoxic burden(1 night)
研究者
Ji-Guang Wang
Director of the Shanghai Institute of Hypertension and the Department of Hypertension
Shanghai Jiao Tong University School of Medicine