NCT07254026 Precision Health and Smart Telerehabilitation in OSA
| NCT ID | NCT07254026 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Cheng-Kung University Hospital |
| Condition | Obstructive Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-10-15 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2025-10-15 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 20 years old and above * Newly diagnosed with mild to severe pure obstructive sleep apnea based on polysomnography Exclusion Criteria: * Severe allergic rhinitis * Sinusitis with nasal polyps * Body Mass Index (BMI) \> 31 * Alcohol or drug abuse within the past year * Pregnancy * Severe obstructive or restrictive pulmonary diseases * High-risk cardiovascular diseases during exercise (e.g., angina, myocardial infarction, heart failure, valvular heart disease) * History of central or peripheral neurological disorders that interfere with exercise prescription * Musculoskeletal or psychological disorders that interfere with exercise prescription * Other non-respiratory sleep disorders * Sleep disorders with concomitant central sleep apnea
Contact & Investigator
Ching-Hsia Hung, PhD
PRINCIPAL INVESTIGATOR
National Cheng Kung University
Frequently Asked Questions
Who can join the NCT07254026 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07254026 currently recruiting?
Yes, NCT07254026 is actively recruiting participants. Contact the research team at junhui.ong611@gmail.com for enrollment information.
Where is the NCT07254026 trial being conducted?
This trial is being conducted at Tainan, Taiwan.
Who is sponsoring the NCT07254026 clinical trial?
NCT07254026 is sponsored by National Cheng-Kung University Hospital. The principal investigator is Ching-Hsia Hung, PhD at National Cheng Kung University. The trial plans to enroll 300 participants.