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Résztvevőt keres itt: TajvanFázis nélkül

Precision Health and Smart Telerehabilitation in OSA

A legfontosabb adatok

Ki végzi
National Cheng-Kung University Hospital
Hol
Tainan (Tajvan)A helyszín megnézése
Azonosító
Állapot
Toboroz
Résztvevők
300 fő, tervezett
Kezdés
2025. okt. 15.
Várható befejezés
2029. dec. 31.
A vizsgálat típusa
Beavatkozással járó, 4 csoport
A vizsgált kezelések
  • Surgery
  • Continuous positive airway pressure
  • Oropharyngeal Exercise with diary
  • Oropharyngeal Exercise with smartphone application
A regiszteradat frissítve
2025. november 28.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for adults newly diagnosed with obstructive sleep apnea, where the airway closes again and again during sleep. Each person gets CPAP, surgery or throat and mouth exercises for 12 weeks.

Életkor
20 years and older
Nem
All sexes
A betegség stádiuma
Mild to severe pure obstructive sleep apnea, newly diagnosed by an overnight sleep study (polysomnography).

A részvétel fő kizáró okai

  • Severe allergic rhinitis, or sinusitis with nasal polyps
  • Body Mass Index (BMI) > 31
  • Alcohol or drug abuse within the past year, or pregnancy
  • Severe lung disease, or heart disease that makes exercise risky
  • Central sleep apnea or other sleep disorders not caused by breathing, or nerve, muscle, bone or mental health problems that get in the way of exercise

A regiszter feltételei, szó szerint

Mind a 13 feltétel megnézéseKevesebb

Ki vehet részt

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

Ki nem vehet részt

  • Alcohol or drug abuse within the past year
  • Sleep disorders with concomitant central sleep apnea
  • Severe allergic rhinitis
  • 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
  • Sinusitis with nasal polyps
  • Body Mass Index (BMI) > 31
  • Pregnancy

Helyszínek itt: Tajvan

  • National Cheng Kung University HospitalTainan, TajvanContact: Ching-Hsia Hung, PhDRésztvevőt keres

A vizsgálatról

Mit akar kideríteni a vizsgálat

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.

A teljes eredeti leírásKevesebb

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.

A vizsgálat 4 csoportja

  • SurgicalA vizsgált kezelés

    Surgery for OSA

    Kezelés: Surgery

  • Continuous positive airway pressureA vizsgált kezelés

    Receive continuous positive airway pressure

  • Oropharyngeal rehabilitation with diaryA vizsgált kezelés

    Receive oropharyngeal telerehabilitation training over three months

    Kezelés: Oropharyngeal Exercise with diary

  • Oropharyngeal rehabilitation with smartphone applicationA vizsgált kezelés

    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

    Kezelés: Oropharyngeal Exercise with smartphone application

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Developing a Precision Health Approach for Obstructive Sleep Apnea: Treatment Responses Analysis and Smart Telerehabilitation Systems
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 14.
A regiszteradat frissítve
2025. november 28.