Precision Health and Smart Telerehabilitation in OSA

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorNational Cheng-Kung University Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

20 years old and above

Newly diagnosed with mild to severe pure obstructive sleep apnea based on polysomnography

Disqualifiers

Severe allergic rhinitis

Sinusitis with nasal polyps

Body Mass Index (BMI) > 31

Alcohol or drug abuse within the past year

Trial design

Design model

Parallel

Treatments tested in this trial

  • Surgery

    Procedure/Surgery

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

  • Continuous positive airway pressure

    Device

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

  • Oropharyngeal Exercise with diary

    Other intervention

    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

    Other intervention

    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.

Treatment groups

300 Participants
are divided into 4 treatment groups
Group A: SurgicalExperimental treatment 1 intervention
Group B: Continuous positive airway pressureExperimental treatment 1 intervention
Group C: Oropharyngeal rehabilitation with diaryExperimental treatment 1 intervention
Group D: Oropharyngeal rehabilitation with smartphone applicationExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Baseline and 12 weeks post intervention

Secondary outcomes

1

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.

Time frame
Baseline and 12 weeks post intervention
2

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.

Time frame
Baseline and 12 weeks post intervention
3

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.

Time frame
Baseline and 12 weeks post intervention
4

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.

Time frame
Baseline and 12 weeks post intervention

Other outcomes

Sponsors and contacts

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