Evaluation of the Correlation Between the Respiratory Index Events Generated by Sunrise® Versus Polysomnography for Sleep Apnea Syndrome Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The performance of Sunrise® to detect the respiratory event index (REI)
研究概览
简要总结
Sleep Apnea Syndrome (SAS) is a serious health issue that should be managed in order to limit its adverse health consequences. SAS is known to induce cardiovascular diseases, diabetes and depression. The prevalence of SAS is still growing with social and economic repercussion. Today, polysomnography (PSG) is the gold standard reference method for SAS diagnosis. However, it is a constraining and expensive technology. In order to improve patients' life quality, many new technologies have been developed for the SAS diagnosis.
The aim of this study is to evaluate the Sunrise®, a new medical integrated solution for SAS diagnosis, in comparison with PSG. This solution consists in a chin sensor recording mandibular movements and measuring the respiratory event index (ERI) through an artificial intelligence algorithm analysis.
详细描述
Sunrise® is a type IIa medical device with the CE label. It is a new home sleep technology, non-invasive, reliable and affordable by the patient.
The objective of this study is to evaluate the efficiency of the device in comparison with PSG for sleep apnea diagnosis.
40 subjects, suspected to be apneic, will be equipped at home by the chin sensor, the Sunrise® device, recording their mandibular movements while sleeping. The Sunrise® solution will provide the respiratory event index (REI) as well as the respiratory micro-arousals.
Inclusion visit will be executed at the University Hospital Grenoble Alpes. However, PSG and Sunrise® will be set at the patient's home by IC@dom. The first night, the patient will be equipped by both PSG and Sunrise® and only by the Sunrise® for the two following nights.
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
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suspected to have a sleep apnea syndrome (Berlin score≥2)
- •Able to use a smartphone application
- •Be legally able to give consent
- •Person affiliated to social security
排除标准
- •Patients already treated for SAS
- •Patients suffering from a chronic obstructive or restrictive pulmonary disease with or without oxygen.
- •Patients suffering from a unstable cardiovascular disease or a severe heart failure requiring an hospitalzation in the previous three months or conform with the New York Heart Association criteria for class II or III diseases
- •Patients treated with myorelaxant medicines
- •Patients with a long beard disabling the setting of the mandibular sensor
- •Subjects listed in articles L1121-5 à L1121-8: Pregnant women, feeding and parturient; subject under administrative or judicial control, persons who are protected under the act.
- •Person in exclusion period for another study or participating in a medical study testing drugs.
- •Subjects not being cooperative or respecting the study instructions, according the investigator.
结局指标
主要结局
The performance of Sunrise® to detect the respiratory event index (REI)
时间窗: 1 night
Evaluation of the correlation between Sunrise® and PSG for the estimation of the REI
次要结局
- Evaluation of the Sunrise® reproductibility on three consecutive nights(3 nights)
- Evaluation of the sleep quality: depth of sleep(3 nights)
- Evaluation of the sleep quality: sleep duration(3 nights)
- Evaluation of the sleep quality: number of wake-ups(3 nights)