RecruitingNot ApplicableNCT07254026

Precision Health and Smart Telerehabilitation in OSA

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


Sponsor

National Cheng-Kung University Hospital

Enrollment

300 participants

Start Date

Oct 15, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 20 Years

Inclusion Criteria2

  • years old and above
  • Newly diagnosed with mild to severe pure obstructive sleep apnea based on polysomnography

Exclusion Criteria11

  • 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

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Interventions

PROCEDURESurgery

Including septomeatoplasty, uvulopalatopharyngoplasty (UPPP), or/and tongue base reduction surgery.

DEVICEContinuous positive airway pressure

Continuous positive airway pressure, 1-5 days a week for three months.

OTHEROropharyngeal Exercise with diary

Oropharyngeal exercise conducted via the telerehabilitation method. Participants are required to attend online supervised sessions of exercises 1-5 days a week for three months. Participants are required to fill out the exercise diary upon completion of the training each day.

OTHEROropharyngeal Exercise with smartphone application

Oropharyngeal exercise conducted via the telerehabilitation method. Participants are required to attend online supervised sessions of exercises 1-5 days a week for three months. In addition to attending the weekly supervised telerehabilitation sessions online, these participants will independently perform the exercises using the smartphone application incorporated with ASMT one to three times per week, with each session lasting approximately 45-60 minutes.


Locations(1)

National Cheng Kung University Hospital

Tainan, Taiwan

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NCT07254026


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