跳至主要内容
临床试验/NCT06522815
NCT06522815招募中不适用

Deep Learning Algorithm Update Using Real Patients for Out-of-hospital Obstructive Sleep Apnea Monitoring

Sky Labs2 个研究点 分布在 2 个国家目标入组 107 人开始时间: 2022年10月19日最近更新:
适应症

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

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)

研究者

发起方
Sky Labs
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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