Deep Learning Algorithm Update Using Real Patients for Out-of-hospital Obstructive Sleep Apnea Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Sky Labs
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- Accuracy of the algorithm and the 95% confidence interval
研究概览
简要总结
The objective is to enhance the reliability of the algorithm to match that of Level 1 polysomnography by leveraging the diverse data obtained from Level 1 polysomnography to refine the deep learning algorithm.
详细描述
Patients undergoing Level 1 polysomnography are equipped with the CART-I PLUS device, for collecting polysomnography data alongside concurrent photoplethysmography (PPG) signals.
The collected data is categorized into apnea, hypopnea, and normal segments based on the polysomnography results. Utilizing the PPG and accelerometer (ACC) signals from the CART-I PLUS, metrics such as SaO2 (oxygen saturation), respiratory rate, heart rate (HR), heart rate variability (HRV), and body movement are calculated for each segment. These metrics, along with the PPG and ACC signals, are then used to develop a deep learning model that classifies the segments into apnea, hypopnea, or normal.
Participants are divided into training and validation sets. The deep learning model is trained on data from the participants in the training set, and its performance is evaluated using the validation set.
The algorithm is constructed using convolutional neural networks (CNN), recurrent neural networks (RNN), attention mechanisms, and other advanced techniques recognized for their efficacy in classification tasks, specifically for identifying apnea, hypopnea, and normal segments.
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
- 19 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients scheduled for Level 1 polysomnography at a sleep center who meet all of the following criteria:
- •Aged 19 years or older
- •Have listened to and understood a thorough explanation of the clinical study and voluntarily agreed to participate
排除标准
- •Under 19 years of age
- •Unable to collect normal signals during the pre-test or wearing of the CART-I PLUS device
- •Refuse to participate in the clinical study
- •Have cognitive impairments to the extent that they cannot understand the explanation of the clinical study and therefore cannot make a voluntary decision to participate (e.g., legally incompetent individuals)
结局指标
主要结局
Accuracy of the algorithm and the 95% confidence interval
时间窗: 11 hours
Present the accuracy of the algorithm and the 95% confidence interval. If the lower bound of the 95% confidence interval exceeds a minimum accuracy of 0.85, it is considered clinically significant.
次要结局
- Accuracy and 95% confidence intervals for each interval(11 hours)
