Pediatric Obstructive Sleep ApneaNCT07805486
Development of a Multimodal Deep Learning Model for Pediatric Patients
An observational study of Pediatric Obstructive Sleep Apnea and Polysomnography, run by Fu Jen Catholic University at 1 site in Taiwan.
Trial summary
This study aims to develop a multimodal data-driven model integrating multiple noninvasive physiological signals to assess the severity of pediatric sleep-disordered breathing, using standard clinical sleep study results as the reference. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Pediatric Obstructive Sleep Apnea, Polysomnography
- What is being tested?
- fingertip pulse oximeter, pressure-sensing mattresses and millimeter-wave radar
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2026to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patient of affiliated university hospital
Who may be able to join
- Individuals with clinical suspicion of obstructive sleep apnea who are referred for polysomnography
Who cannot join
- Intolerance to a fingertip or wrap-around pulse oximeter
- Presence of significant structural abnormalities of the upper airway
- Cardiac arrhythmia
- Neuromuscular disease
- Hospitalization within the previous one month
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Fu Jen Catholic University Hospital, Fu Jen Catholic University
New Taipei City, 24352
Ke-Yun Chao, PhD, +886-905-301-879, C00152@mail.fjuh.fju.edu.tw
About this study
Official title: Development of an Artificial Intelligence-Based Model for Assessing the Severity of Pediatric Obstructive Sleep Apnea
This study aims to develop a multimodal data-driven model integrating multiple noninvasive physiological signals to assess the severity of pediatric sleep-disordered breathing, using standard clinical sleep study results as the reference.
Read the detailed description
Pediatric obstructive sleep apnea may affect growth, development, cognitive function, and overall health. Although polysomnography is commonly used for clinical assessment, its application may be limited by time, cost, and accessibility. Recent advances in noninvasive monitoring technologies have provided new possibilities for sleep-related assessment. This study will collect and integrate multiple physiological signals from pediatric participants undergoing routine sleep examinations and to develop a data-driven model for evaluating sleep-related respiratory conditions. Clinical examination results will be used as the reference for model development and validation. The findings of this study are expected to support the development of a convenient and noninvasive approach for pediatric sleep assessment and may provide a reference for future clinical and home-based applications.
- Conditions
- Pediatric Obstructive Sleep Apnea, Polysomnography
- Being tested
- fingertip pulse oximeter, pressure-sensing mattresses, millimeter-wave radar
- Keywords
- pediatric obstructive sleep apnea, polysomnography, smart mattress, millimeter-wave radar, multimodal deep learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fingertip pulse oximeterDevice
a small device placed on the finger to measure blood oxygen saturation and pulse rate noninvasively
pressure-sensing mattressesDevice
using ballistocardiography for monitoring respiration and heart rate
millimeter-wave radarDevice
using millimeter-wave radar technology based on the Doppler effect, the device continuously monitors respiratory-related chest wall movements
What is being measured
The primary outcome is the main question the study is designed to answer.
the correlation among the apnea-hypopnea index, millimeter-wave radar signals, and ballistocardiography waveforms
Measured: up to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ke-Yun, Chao, Fu Jen Catholic University
- Investigators
- Ke-Yun Chao, PhD, Principal investigator, Fu Jen Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805486
- Sponsor's protocol ID
- FJUH115604
- Status last verified
- Aug 2026
- First submitted
- 1 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Artificial Intelligence-Based Model for Assessing the Severity of Pediatric Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT07805486
- Acronym / sponsor ID
- FJUH115604
- Conditions
- Pediatric Obstructive Sleep Apnea, Polysomnography
- Keywords
- pediatric obstructive sleep apnea, polysomnography, smart mattress, millimeter-wave radar, multimodal deep learning
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fu Jen Catholic UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to develop a multimodal data-driven model integrating multiple noninvasive physiological signals to assess the severity of pediatric sleep-disordered breathing, using standard clinical sleep study results as the reference.
Detailed description
Pediatric obstructive sleep apnea may affect growth, development, cognitive function, and overall health. Although polysomnography is commonly used for clinical assessment, its application may be limited by time, cost, and accessibility. Recent advances in noninvasive monitoring technologies have provided new possibilities for sleep-related assessment. This study will collect and integrate multiple physiological signals from pediatric participants undergoing routine sleep examinations and to develop a data-driven model for evaluating sleep-related respiratory conditions. Clinical examination results will be used as the reference for model development and validation. The findings of this study are expected to support the development of a convenient and noninvasive approach for pediatric sleep assessment and may provide a reference for future clinical and home-based applications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patient of affiliated university hospital
Key inclusion criteria (1 listed)
- Individuals with clinical suspicion of obstructive sleep apnea who are referred for polysomnography
Key exclusion criteria (5 listed)
- Intolerance to a fingertip or wrap-around pulse oximeter
- Presence of significant structural abnormalities of the upper airway
- Cardiac arrhythmia
- Neuromuscular disease
- Hospitalization within the previous one month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fingertip pulse oximetera small device placed on the finger to measure blood oxygen saturation and pulse rate noninvasively | Device | – |
| pressure-sensing mattressesusing ballistocardiography for monitoring respiration and heart rate | Device | – |
| millimeter-wave radarusing millimeter-wave radar technology based on the Doppler effect, the device continuously monitors respiratory-related chest wall movements | Device | – |
Primary outcome
the correlation among the apnea-hypopnea index, millimeter-wave radar signals, and ballistocardiography waveforms
Time frame: up to 12 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ke-Yun Chao, PhD principal investigator
Fu Jen Catholic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Obstructive Sleep Apnea and Polysomnography, run by Fu Jen Catholic University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ke-Yun Chao, PhD (+886-905-301-879, C00152@mail.fjuh.fju.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the correlation among the apnea-hypopnea index, millimeter-wave radar signals, and ballistocardiography waveforms (time frame: up to 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.