- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07447999
Multimodal Deep Learning Model for Predicting the Apnea-Hypopnea Index in Obstructive Sleep
March 3, 2026 updated by: Ke-Yun, Chao, Fu Jen Catholic University
A Multisensor Deep Neural Framework Combining Digital Auscultation, Oxygen Saturation, and Motion Data to Estimate the Apnea-Hypopnea Index in Obstructive Sleep Apnea
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Observational
Enrollment (Estimated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ke-Yun Chao, PhD
- Phone Number: +886-905-301-879
- Email: C00152@mail.fjuh.fju.edu.tw
Study Locations
-
-
-
New Taipei City, Taiwan, 24352
- Recruiting
- Fu Jen Catholic University Hospital, Fu Jen Catholic University
-
Contact:
- Ke-Yun Chao, PhD
- Phone Number: +886-905-301-879
- Email: C00152@mail.fjuh.fju.edu.tw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
patient of Affiliated University Hospital
Description
Inclusion Criteria:
- age 30-75 years
- clinically suspected obstructive sleep apnea and scheduled for polysomnography
- willing and able to provide written informed consent
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
apnea-hypopnea index, sound waveforms, and the correlation between apnea-hypopnea index and ballistocardiography waveforms
Time Frame: one night
|
one night
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ke-Yun Chao, PhD, Fu Jen Catholic University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 5, 2025
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
July 31, 2026
Study Registration Dates
First Submitted
February 26, 2026
First Submitted That Met QC Criteria
February 26, 2026
First Posted (Actual)
March 4, 2026
Study Record Updates
Last Update Posted (Actual)
March 5, 2026
Last Update Submitted That Met QC Criteria
March 3, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FJUH114486
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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