A Clinical Trial Evaluating the Effectiveness and Safety of a Millimeter-Wave Radar Based Sleep Respiratory Monitoring System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Diagnostic Sensitivity (AHI≥5) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)
研究概览
简要总结
This study compares the diagnostic capability of a millimeter-wave radar-based Sleep Respiratory Monitoring System to the gold standard polysomnography.
详细描述
The gold standard for the diagnosis of sleep breathing disorders is polysomnography (PSG), which requires contact sensors, in-lab monitoring and manual scoring by experts, limiting the comfortability of patients and accessibility of diagnosis. A novel contactless millimeter-wave radar-based Sleep Respiratory Monitoring System is developed, in order to assist sleep staging and the diagnosis of sleep breathing disorders.
The Sleep Respiratory Monitoring System is capable of collecting, recording, storing and analyzing breathing, heartbeat, spatial distribution of full-body movements, etc. via a millimeter-wave radar, and oxygen saturation, pulse, etc. via a pulse oximeter. A dedicated algorithm enables the system to detect respiratory events and estimate sleep stages based on the collected data. The device and algorithms are to be validated in this study by comparison with PSG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
During this study, results of the radar-based Sleep Respiratory Monitoring System are not known by the investigator and outcomes assessor, including the personnel who scores PSG.
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
- •Participants is 18 years of age or older.
- •Participants is willing to undergo overnight polysomnography and Sleep Respiratory Monitoring System testing.
排除标准
- •Participants with severe cardiovascular and cerebrovascular diseases, severe liver, kidney, and lung dysfunction.
- •Participants with unstable respiratory diseases, or other diseases in acute phase.
- •Long-term or current use of barbiturates, benzodiazepines, sedatives and other drugs that may affect sleep.
- •Participants that undergo CPAP treatment during the night of the trial.
- •Participants with other sleep disorders, e.g. insomnia.
- •Participants with mental disorders.
- •Participants that refuse to sign informed consents.
- •Participants unable to cooperate with medical examination.
- •Participants excluded in the opinion of the investigator.
结局指标
主要结局
Diagnostic Sensitivity (AHI≥5) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)
时间窗: Day 1
The proportion of participants with Apnea Hypopnea Index (AHI) ≥ 5 events per hour according to SRMS in participants with AHI ≥ 5 events per hour according to PSG scored with American Academy of Sleep Medicine (AASM) v2.6 Guidelines. The point estimation of diagnostic sensitivity of SRMS will be compared to the threshold of 0.8, with the half width of 95% confidence interval being no more than 0.1.
Diagnostic Sensitivity (AHI≥30) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)
时间窗: Day 1
The proportion of participants with Apnea Hypopnea Index (AHI) ≥ 30 events per hour according to SRMS in participants with AHI ≥ 30 events per hour according to PSG scored with American Academy of Sleep Medicine (AASM) v2.6 Guidelines. The point estimation of diagnostic sensitivity of SRMS will be compared to the threshold of 0.8, with the half width of 95% confidence interval being no more than 0.1.
Diagnostic Specificity (AHI≥5) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)
时间窗: Day 1
The proportion of participants with Apnea Hypopnea Index (AHI) \< 5 events per hour according to SRMS in participants with AHI \< 5 events per hour according to PSG scored with American Academy of Sleep Medicine (AASM) v2.6 Guidelines. The point estimation of diagnostic specificity of SRMS will be compared to the threshold of 0.8, with the half width of 95% confidence interval being no more than 0.1.
Diagnostic Specificity (AHI≥30) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)
时间窗: Day 1
The proportion of participants with Apnea Hypopnea Index (AHI) \< 30 events per hour according to SRMS in participants with AHI \< 30 events per hour according to PSG scored with American Academy of Sleep Medicine (AASM) v2.6 Guidelines. The point estimation of diagnostic specificity of SRMS will be compared to the threshold of 0.8, with the half width of 95% confidence interval being no more than 0.1.
Diagnostic Sensitivity (AHI≥15) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)
时间窗: Day 1
The proportion of participants with Apnea Hypopnea Index (AHI) ≥ 15 events per hour according to SRMS in participants with AHI ≥ 15 events per hour according to PSG scored with American Academy of Sleep Medicine (AASM) v2.6 Guidelines. The point estimation of diagnostic sensitivity of SRMS will be compared to the threshold of 0.8, with the half width of 95% confidence interval being no more than 0.1.
Diagnostic Specificity (AHI≥15) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)
时间窗: Day 1
The proportion of participants with Apnea Hypopnea Index (AHI) \< 15 events per hour according to SRMS in participants with AHI \< 15 events per hour according to PSG scored with American Academy of Sleep Medicine (AASM) v2.6 Guidelines. The point estimation of diagnostic specificity of SRMS will be compared to the threshold of 0.8, with the half width of 95% confidence interval being no more than 0.1.
次要结局
- Intra-Class Correlation Coefficient (ICC) of Light Sleep Proportion(Day 1)
- Intra-Class Correlation Coefficient (ICC) of Deep Sleep Proportion(Day 1)
- Intra-Class Correlation Coefficient (ICC) of Apnea Hypopnea Index (AHI)(Day 1)
- Intra-Class Correlation Coefficient (ICC) of Total Sleep Time (TST)(Day 1)
- Intra-Class Correlation Coefficient (ICC) of Rapid Eye Movement (REM) Sleep Proportion(Day 1)