Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2025-10-15
2029-12-31
Brief Summary
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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.
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Detailed Description
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The study will be conducted in two phases. In Phase I, researchers will analyze a large dataset of polysomnography (PSG) records obtained from the Sleep Center at National Cheng Kung University Hospital. Machine learning methods will be applied to identify predictive patterns that distinguish responders from non-responders across treatments such as Continuous Positive Airway Pressure (CPAP), surgical intervention, and oropharyngeal rehabilitation (OPR).
In Phase II, a prospective clinical trial will be implemented. Patients newly diagnosed with OSA will be allocated to CPAP, surgical, or OPR interventions (with either an exercise diary or a smartphone application) according to the AI-generated treatment recommendations, supplemented by physician judgment and patient preference. Each intervention will last 12 weeks, after which repeat PSG and clinical evaluations will be conducted to assess treatment efficacy.
Participants in the CPAP arm will undergo 12 weeks of nightly CPAP use. Participants in the surgical group will receive operative treatment for OSA. Those assigned to the OPR arm will complete 12 weeks of telerehabilitation training focused on oropharyngeal exercises. Within the OPR group, participants will be further divided into two subgroups: one will record adherence using an exercise diary, while the other will train with a smartphone application integrated with a pressure sensor and facial motion recognition technology. This system will provide real-time feedback, record adherence, and transmit performance data to a secure cloud platform, enabling remote monitoring and clinician-guided adjustments.
The study aims to determine whether AI can deliver clinically reliable, personalized treatment recommendations and whether app-based telerehabilitation can improve adherence and treatment outcomes. The anticipated results are expected to advance precision medicine approaches in OSA management and enhance both patient care and healthcare efficiency.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Surgical
Surgery for OSA
Surgery
Including septomeatoplasty, uvulopalatopharyngoplasty (UPPP), or/and tongue base reduction surgery.
Continuous positive airway pressure
Receive continuous positive airway pressure
Continuous positive airway pressure
Continuous positive airway pressure, 1-5 days a week for three months.
Oropharyngeal rehabilitation with diary
Receive oropharyngeal telerehabilitation training over three months
Oropharyngeal 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.
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
Oropharyngeal 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.
Interventions
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Surgery
Including septomeatoplasty, uvulopalatopharyngoplasty (UPPP), or/and tongue base reduction surgery.
Continuous positive airway pressure
Continuous positive airway pressure, 1-5 days a week for three months.
Oropharyngeal 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.
Oropharyngeal 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.
Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed with mild to severe pure obstructive sleep apnea based on polysomnography
Exclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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National Cheng-Kung University Hospital
OTHER
Responsible Party
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Principal Investigators
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Ching-Hsia Hung, PhD
Role: PRINCIPAL_INVESTIGATOR
National Cheng Kung University
Locations
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National Cheng Kung University Hospital
Tainan, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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B-BR-114-020
Identifier Type: -
Identifier Source: org_study_id
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