Validation of a New Non-intrusive Technology for Detecting Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Sensitivity and Specificity of MOVESENSE sensor in detecting patients suffering from apnea
研究概览
简要总结
Obstructive sleep apnea (OSA) is a prevalent kind of sleep-disordered breathing affecting one-seventh of the world's population. Almost 45 percent of this population suffers from mild to severe apnea. However, in many cases it remains undiagnosed, leading to increased health risks. Sleep-disordered breathing, as seen in OSA, can have serious long-term consequences, including sympathetic nervous system activation, sleep disturbances, heart remodeling, and cardiovascular disease development.
Polysomnography is the standard method for assessing sleep-breathing disorders, which requires the attachment of various sensors by a trained technician or a healthcare professional. However, if the diagnosis of OSA depends on referral to a sleep laboratory, and if the referral is reliant on symptoms of an OSA syndrome, then current screening approaches may exclude a large population of individuals at risk. Besides, the number of sleep centers and caregivers is limited, and the associated costs are high. Therefore, alternative techniques allowing home monitoring are necessary.
The goal of this observational study is to evaluate the accuracy of the Kinocardiography technique in detecting apneic episodes during sleep and comparing the results with the gold standard polysomnography in 47 patients suffering from obstructive sleep apnea. We hypothesize that this device is able to detect sleep-disordered breathing events, and thus to compute the apnea-hypopnea index, with an accuracy that is close to that of the polysomnography.
Participants who meet the criteria will be invited to participate in this protocol and do both polysomnography and kinocardiography records simultaneously at night during sleep.
详细描述
- Study Glossary
- BCG = Ballistocardiography
- ECG = Electrocardiography
- PSG = Polysomnography
- SCG = Seismocardiography
- KCG = Kinocardiography
- Monitoring Technique
Ballistocardiography (BCG) and seismocardiography (SCG) are two promising technologies for monitoring vital signs during sleep. BCG measures body movements caused by blood flow ejection at each cardiac contraction, while SCG detects micro-vibrations from heart contractions on the chest surface. These low-cost and unobtrusive technologies have been used in various sleep studies, showing promise in vital sign recording, detecting abnormal breathing episodes, and studying the effects of disease and environmental conditions. However, more research and replication of studies are required for widespread application.
Kinocardiography:
Kinocardiography (KCG) is a technique that combines BCG and SCG with electrocardiography (ECG). The BCG module is placed close to the subject's center of mass in the lumbar vertebrae. The SCG module is placed on the sternum beneath the clavicle, close to the heart and major blood vessels. Each module is a MOVESENSE device that incorporates a three-axis accelerometer and three-axis gyroscope sensor and is attached to the body using standard sticky gel electrodes and a belt. The overall system is remotely controlled via a Bluetooth-connected smartphone or tablet. This device allows the measurement of the micro-accelerations induced by the cardiac activity at the body's surface. By computing these accelerations, it is possible to calculate other parameters, such as the kinetic energies associated with the contraction of the heart.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participants should be adult patients who come to Erasme Hospital's sleep department with complaints about sleep disturbances.
- •18 < age <70
- •BMI < 35 kg/m2
排除标准
- •Being under any kind of obstructive sleep apnea treatment (cPAP therapy, etc.)
- •Having been diagnosed with Atrial fibrillation, significant valvular heart disease, or ventricular dysfunction
- •Age <18 or age > 70
- •BMI > 35 kg/m2
结局指标
主要结局
Sensitivity and Specificity of MOVESENSE sensor in detecting patients suffering from apnea
时间窗: During 1 night (~8hours)
Sensitivity and Specificity of MOVESENSE sensor in detecting patients suffering from apnea based on the apnea-hypopnea index (AHI) and different grades of severity: AHI\<5; 5\<AHI\<15; 15\<AHI\<30; 30\<AHI.
次要结局
- Variation of kinetic energy during apneic episodes(During 1 night (~8hours))
研究者
Philippe Van de Borne
Professor
Erasme University Hospital