Precision Health and Smart Telerehabilitation in OSA

NCT07254026 | Recruiting

• 1 other identifier: B-BR-114-020
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Apnea-Hypopnea Index

  The apnea-hypopnea index will be obtained from the overnight Polysomnography (PSG) study. PSG will be performed in the sleep center of National Cheng Kung University Hospital. Less than 5 events/hour indicates normal; AHI between 5-14 events/hour indicates mild Obstructive Sleep Apnea(OSA); AHI between 15-30 events/hour indicates moderate OSA; and AHI more than 30 events/hour indicates severe OSA.

  Baseline and 12 weeks post intervention

Secondary Outcomes (10)

• Daytime Sleepiness Level

  Baseline and 12 weeks post intervention

• Sleep Quality

  Baseline and 12 weeks post intervention

• Pharyngeal Airway Volume

  Baseline and 12 weeks post intervention

• Cross Section Area on the Tip of Epiglottis

  Baseline and 12 weeks post intervention

• Anterior to Posterior Distance on the Tip of the Epiglottis

  Baseline and 12 weeks post intervention

Study Arms (4)

Surgical

EXPERIMENTAL

Surgery for OSA

Procedure: Surgery

Continuous positive airway pressure

EXPERIMENTAL

Receive continuous positive airway pressure

Device: Continuous positive airway pressure

Oropharyngeal rehabilitation with diary

EXPERIMENTAL

Receive oropharyngeal telerehabilitation training over three months

Other: Oropharyngeal Exercise with diary

Oropharyngeal rehabilitation with smartphone application

EXPERIMENTAL

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

Other: Oropharyngeal Exercise with smartphone application

Interventions

Surgery PROCEDURE

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

Surgical

Continuous positive airway pressure DEVICE

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

Continuous positive airway pressure

Oropharyngeal Exercise with diary OTHER

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 diary

Oropharyngeal Exercise with smartphone application OTHER

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.

Oropharyngeal rehabilitation with smartphone application

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Surgical Procedures, Operative; Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Ching-Hsia Hung, PhD

  National Cheng Kung University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun-Hui Ong, MS

CONTACT

+886-9-37839992; junhui.ong611@gmail.com

Ching-Hsia Hung, PhD

CONTACT

+886-6-2353535; chhung@mail.ncku.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: November 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)