NCT07447999

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress79%
Sep 2025Jul 2026

Study Start

First participant enrolled

September 5, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

March 5, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

February 26, 2026

Last Update Submit

March 3, 2026

Conditions

Keywords

obstructive sleep apneapolysomnographyballistocardiographyelectronic stethoscopeoxygen saturation

Outcome Measures

Primary Outcomes (1)

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

    one night

Interventions

digital device amplifying and recording cardiopulmonary sounds

a small device placed on the finger to measure blood oxygen saturation (SpO₂) and pulse rate noninvasively.

using ballistocardiography (BCG) for monitoring respiration and heart rate

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patient of Affiliated University Hospital

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fu Jen Catholic University Hospital, Fu Jen Catholic University

New Taipei City, 24352, Taiwan

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Ke-Yun Chao, PhD

    Fu Jen Catholic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 26, 2026

First Posted

March 4, 2026

Study Start

September 5, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

March 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations