Developing a Precision Health Approach for Obstructive Sleep Apnea: Treatment Responses Analysis and Smart Telerehabilitation Systems

Status: Recruiting
Location: See location...
Intervention Type: Other, Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study aims to improve treatment strategies for Obstructive Sleep Apnea (OSA), a disorder characterized by recurrent upper airway collapse during sleep, resulting in reduced oxygenation, sleep fragmentation, and excessive daytime sleepiness. The objectives are twofold: to evaluate whether an artificial intelligence (AI)-based model can accurately predict the most effective treatment for individual patients, and to assess whether a mobile health application can enhance adherence to oropharyngeal rehabilitation (OPR) and improve therapeutic outcomes. The study will be conducted in two phases. In Phase I, a retrospective analysis will be performed using a large dataset of polysomnography (PSG) records obtained from the Sleep Center at National Cheng Kung University Hospital. Machine learning algorithms will be applied to identify predictive features that differentiate responders from non-responders across Continuous Positive Airway Pressure (CPAP), surgical, and OPR interventions. These findings will inform the development of a predictive treatment recommendation model. In Phase II, a prospective clinical trial will validate the predictive accuracy and clinical utility of the model. Patients newly diagnosed with OSA will be assigned to CPAP, surgery, or OPR interventions according to the model's recommendations, in combination with physician judgment and patient preference. Each intervention will last 12 weeks, followed by repeat PSG and clinical assessments. Within the OPR arm, participants will be further randomized to monitor adherence via an exercise diary or a smartphone application equipped with a pressure sensor and facial motion recognition technology, enabling real-time feedback and remote monitoring. This trial is expected to determine whether AI can provide clinically reliable treatment recommendations and whether digital telerehabilitation can improve adherence and outcomes, thereby advancing precision medicine in OSA management.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

• 20 years old and above

• Newly diagnosed with mild to severe pure obstructive sleep apnea based on polysomnography

Locations
Other Locations
Taiwan
National Cheng Kung University Hospital
RECRUITING
Tainan
Contact Information
Primary
Jun-Hui Ong, MS
junhui.ong611@gmail.com
+886-9-37839992
Backup
Ching-Hsia Hung, PhD
chhung@mail.ncku.edu.tw
+886-6-2353535
Time Frame
Start Date: 2025-10-15
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 300
Treatments
Experimental: Surgical
Surgery for OSA
Experimental: Continuous positive airway pressure
Receive continuous positive airway pressure
Experimental: Oropharyngeal rehabilitation with diary
Receive oropharyngeal telerehabilitation training over three months
Experimental: Oropharyngeal rehabilitation with smartphone application
Receive oropharyngeal telerehabilitation training incorporated with a smartphone application (Adaptive Sensor-Based Motion Tracking, ASMT system, which consisted of a pressure sensor and facial motion recognition technology) for over three months
Sponsors
Leads: National Cheng-Kung University Hospital

This content was sourced from clinicaltrials.gov