跳至主要内容
临床试验/NCT07447999
NCT07447999招募中不适用

A Multisensor Deep Neural Framework Combining Digital Auscultation, Oxygen Saturation, and Motion Data to Estimate the Apnea-Hypopnea Index in Obstructive Sleep Apnea

Fu Jen Catholic University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年9月5日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
apnea-hypopnea index, sound waveforms, and the correlation between apnea-hypopnea index and ballistocardiography waveforms

研究概览

简要总结

This study aims to develop a multimodal deep learning model that integrates noninvasive signals to predict the severity of obstructive sleep apnea. By establishing a clinically viable and user-friendly monitoring tool, the study seeks to enhance early screening accessibility and support the development of home-based sleep care systems.

详细描述

Obstructive sleep apnea is a common sleep disorder closely associated with cardiovascular, metabolic, and neuropsychiatric comorbidities. It is characterized by repeated upper airway collapse during sleep, leading to intermittent hypoxia and sleep fragmentation. Although polysomnography remains the diagnostic gold standard for obstructive sleep apnea, its high cost, complexity, and limited accessibility pose challenges for large-scale screening and early identification. Recent advancements in noninvasive sensing technologies-such as electronic stethoscopes, wearable oximeters, and under-mattress pressure sensors-have enabled low-burden physiological monitoring solutions, offering new opportunities for simplified obstructive sleep apnea detection. In this study, synchronized multimodal physiological data will be collected during overnight sleep, including respiratory sounds, continuous saturation measurements, and standard polysomnography waveforms. Signal preprocessing and feature extraction will be performed to ensure data quality and temporal alignment. A deep learning model will be developed using these multimodal signals as inputs. The apnea-hypopnea index will be derived from overnight polysomnography. The model will be trained to estimate apnea-hypopnea index values and classify obstructive sleep apnea severity according to established clinical thresholds.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 30-75 years
  • clinically suspected obstructive sleep apnea and scheduled for polysomnography
  • willing and able to provide written informed consent

排除标准

  • intolerance to the electronic stethoscope or fingertip pulse oximeter
  • significant structural airway abnormalities
  • arrhythmia
  • neuromuscular disorders
  • pregnancy
  • hospitalization within the past 1 month
  • inability to provide informed consent or requiring legal guardian consent

结局指标

主要结局

apnea-hypopnea index, sound waveforms, and the correlation between apnea-hypopnea index and ballistocardiography waveforms

时间窗: one night

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ke-Yun, Chao

Assistant Professor

Fu Jen Catholic University

研究点 (1)

Loading locations...

相似试验