Obstructive Sleep ApneaNCT07254026
Precision Health and Smart Telerehabilitation in OSA
A study testing Surgery, Continuous positive airway pressure and Oropharyngeal Exercise with diary in people with Obstructive Sleep Apnea, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Surgery, Continuous positive airway pressure and Oropharyngeal Exercise with diary
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Oct 2025to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 years old and above
- Newly diagnosed with mild to severe pure obstructive sleep apnea based on polysomnography
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng Kung University Hospital
Tainan, 704
Ching-Hsia Hung, PhD, +886-6-2353535 ext. 5939, chhung@mail.ncku.edu.tw
About this study
Official title: Developing a Precision Health Approach for Obstructive Sleep Apnea: Treatment Responses Analysis and Smart Telerehabilitation Systems
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.
Read more
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.
Read the detailed description
This study is designed to improve treatment strategies for Obstructive Sleep Apnea (OSA), a disorder characterized by reduced oxygenation and recurrent sleep disturbances. The research has two primary objectives: first, to evaluate whether an artificial intelligence (AI)-based model can accurately predict the most effective treatment for individual patients; and second, to assess whether a mobile health application can facilitate oropharyngeal exercise training, thereby enhancing adherence and therapeutic outcomes.
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
- Obstructive Sleep Apnea
- Being tested
- Surgery, Continuous positive airway pressure, Oropharyngeal Exercise with diary, Oropharyngeal Exercise with smartphone application
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Including septomeatoplasty, uvulopalatopharyngoplasty (UPPP), or/and tongue base reduction surgery.
Continuous positive airway pressureDevice
Continuous positive airway pressure, 1-5 days a week for three months.
Oropharyngeal Exercise with diaryOther
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 applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Surgical | Experimental | Surgery for OSA Receives: Procedure: Surgery |
| Continuous positive airway pressure | Experimental | Receive continuous positive airway pressure Receives: Device: Continuous positive airway pressure |
| Oropharyngeal rehabilitation with diary | Experimental | Receive oropharyngeal telerehabilitation training over three months Receives: 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 Receives: Other: Oropharyngeal Exercise with smartphone application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 weeks post intervention
Secondary outcomes (10)
Daytime Sleepiness Level
Epworth Sleepiness Score(ESS) will be used to measure the daytime sleepiness of OSA patients. The total score of ESS range from 0-24. A score greater than 10 indicates greater daytime sleepiness.
Measured: Baseline and 12 weeks post intervention
Sleep Quality
Sleep quality will be measured using Pittsburgh Sleep Quality Index (PSQI).The total score ranges from 0 to 21 with a higher total score equal to or more than 5 indicating worse sleep quality.
Measured: Baseline and 12 weeks post intervention
Pharyngeal Airway Volume
Computer Tomography (CT) will be performed. The pharyngeal airway volume will be calculated from the hard palate to the epiglottis and the data will be presented in cm^3. The minimum score is 0 and a higher score indicates greater in pharyngeal airway volume.
Measured: Baseline and 12 weeks post intervention
Cross Section Area on the Tip of Epiglottis
Computer Tomography (CT) will be performed. Cross section area on the tip of the epiglottis was measured and the data will be presented in cm^2. The minimum score is 0 and a higher score indicates greater in the cross-sectional area of the region.
Measured: Baseline and 12 weeks post intervention
Anterior to Posterior Distance on the Tip of the Epiglottis
The distance between the anterior and posterior pharyngeal wall on the tip of the epiglottis will be measured and presented in cm. The minimal value will be 0 and the greater value indicates a greater distance between the anterior to posterior in this area.
Measured: Baseline and 12 weeks post intervention
Lateral Distance on the Tip of Epiglottis
The distance between the lateral distance on the tip of the epiglottis will be measured and presented in cm. The minimal value will be 0 and the greater value indicates a greater distance between the lateral wall.
Measured: Baseline and 12 weeks post intervention
Median Usage Hours of Continuous Positive Airway Pressure
The average number of hours per night that participants use CPAP will be recorded from CPAP usage reports. Greater nightly usage is considered indicative of better compliance and treatment effectiveness.
Measured: 1-week average pre intervention, 1-week average post intervention and 1-month average during intervention for 3 months
Median Pressure in Continuous Positive Airway Pressure
The change in therapeutic CPAP pressure required to maintain airway patency will be assessed using CPAP usage reports. A reduction in required pressure is expected to indicate improved upper airway muscle tone and stability.
Measured: 1-week average pre intervention, 1-week average post intervention and 1-month average during intervention for 3 months
Tongue Muscle Strength
The maximal muscle strength of genioglossus muscles using The Iowa Oral Performance Instrument (IOPI) system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA) (kPa)
Measured: Baseline and 12 weeks post intervention
Tongue Muscle Endurance
The endurance of the genioglossus muscles using The Iowa Oral Performance Instrument (IOPI) system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA) (in seconds).
Measured: Baseline and 12 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start15 Oct 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ching-Hsia Hung, PhD, Principal investigator, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254026
- Sponsor's protocol ID
- B-BR-114-020
- Status last verified
- Oct 2025
- First submitted
- 19 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Precision Health Approach for Obstructive Sleep Apnea: Treatment Responses Analysis and Smart Telerehabilitation Systems
- ClinicalTrials.gov ID
- NCT07254026
- Acronym / sponsor ID
- B-BR-114-020
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is designed to improve treatment strategies for Obstructive Sleep Apnea (OSA), a disorder characterized by reduced oxygenation and recurrent sleep disturbances. The research has two primary objectives: first, to evaluate whether an artificial intelligence (AI)-based model can accurately predict the most effective treatment for individual patients; and second, to assess whether a mobile health application can facilitate oropharyngeal exercise training, thereby enhancing adherence and therapeutic outcomes.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Surgical | Experimental | Procedure: SurgerySurgery for OSA |
| Continuous positive airway pressure | Experimental | Device: Continuous positive airway pressureReceive continuous positive airway pressure |
| Oropharyngeal rehabilitation with diary | Experimental | Other: Oropharyngeal Exercise with diaryReceive oropharyngeal telerehabilitation training over three months |
| Oropharyngeal rehabilitation with smartphone application | Experimental | Other: Oropharyngeal Exercise with smartphone applicationReceive 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 20 years old and above
- Newly diagnosed with mild to severe pure obstructive sleep apnea based on polysomnography
Key exclusion criteria (11 listed)
- Severe allergic rhinitis
- Sinusitis with nasal polyps
- Body Mass Index (BMI) > 31
- Alcohol or drug abuse within the past year
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgeryIncluding septomeatoplasty, uvulopalatopharyngoplasty (UPPP), or/and tongue base reduction surgery. | Procedure or surgery | Surgical |
| Continuous positive airway pressureContinuous positive airway pressure, 1-5 days a week for three months. | Device | Continuous positive airway pressure |
| Oropharyngeal Exercise with diaryOropharyngeal 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. | Other | Oropharyngeal rehabilitation with diary |
| Oropharyngeal Exercise with smartphone applicationOropharyngeal 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. | Other | Oropharyngeal rehabilitation with smartphone application |
Primary outcome
Apnea-Hypopnea Index
Time frame: Baseline and 12 weeks post intervention
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.
10 secondary outcomes
Daytime Sleepiness Level
Time frame: Baseline and 12 weeks post intervention
Sleep Quality
Time frame: Baseline and 12 weeks post intervention
Pharyngeal Airway Volume
Time frame: Baseline and 12 weeks post intervention
Cross Section Area on the Tip of Epiglottis
Time frame: Baseline and 12 weeks post intervention
Anterior to Posterior Distance on the Tip of the Epiglottis
Time frame: Baseline and 12 weeks post intervention
Lateral Distance on the Tip of Epiglottis
Time frame: Baseline and 12 weeks post intervention
Median Usage Hours of Continuous Positive Airway Pressure
Time frame: 1-week average pre intervention, 1-week average post intervention and 1-month average during intervention for 3 months
Median Pressure in Continuous Positive Airway Pressure
Time frame: 1-week average pre intervention, 1-week average post intervention and 1-month average during intervention for 3 months
Tongue Muscle Strength
Time frame: Baseline and 12 weeks post intervention
Tongue Muscle Endurance
Time frame: Baseline and 12 weeks post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
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A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ching-Hsia Hung, PhD principal investigator
National Cheng Kung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery, Continuous positive airway pressure and Oropharyngeal Exercise with diary in people with Obstructive Sleep Apnea, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun-Hui Ong, MS (+886-9-37839992, junhui.ong611@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-Hypopnea Index (time frame: Baseline and 12 weeks post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.