RecruitingNot ApplicableNCT06512779

Developing a Treatment Clustering System for Obstructive Sleep Apnea Using Polysomnographic Physiological Signals


Sponsor

National Cheng-Kung University Hospital

Enrollment

150 participants

Start Date

Jul 30, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Obstructive sleep apnea syndrome (OSA) is marked by repeated upper airway obstructions during sleep, affecting approximately 14% of men and 5% of women aged 30-70 years. However, precise clinical prediction tools for selecting optimal treatment strategies are lacking. This study aims to develop an automated treatment clustering system using artificial intelligence to classify patients based on etiology into (i) anatomical factors, (ii) reduced muscle responsiveness, and (iii) other non-anatomical factors. This system will analyze physiological sleep assessments, such as electromyography (EMG) and pneumotachographs, from a retrospective polysomnography (PSG) database. Cross-validation will be conducted on new OSA patients undergoing various management strategies, including surgical intervention, CPAP therapy, and oropharyngeal training (delivered face-to-face or via telerehabilitation). This system aims to enhance clinicians' ability to predict treatment success rates and improve patient outcomes.


Eligibility

Min Age: 20 Years

Inclusion Criteria2

  • OSA patients
  • Aged over 20 years

Exclusion Criteria11

  • BMI≧ 32
  • Central or mixed types of sleep apnea
  • A history of malignancy or infection of the head and neck region and laryngeal trauma
  • Craniofacial malformation
  • Stroke
  • Neuromuscular disease
  • Severe cardiovascular disease
  • Active psychiatric disease
  • Structural abnormalities over the upper respiratory airway
  • Performed any operation or treatment over the neck before
  • Pregnancy

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Interventions

OTHERControl Group

sleep hygiene education

PROCEDURESurgical Intervention

Surgical Intervention includes uvulopalatopharyngoplasty (UPPP) and transoral robotic surgery (TORS). UPPP involves the removal of the uvula and tonsils, while TORS consists of the removal of the uvula, tonsils, and adipose tissue at the base of the tongue.

OTHEROropharyngeal Training (face-to-face)

Participants will attend face-to-face oropharyngeal training sessions with a therapist in the lab, each lasting 45-60 minutes, 1-2 times per week, over a 12-week intervention period.

OTHEROropharyngeal Training (telerehabilitation)

Participants will attend online oropharyngeal training (telerehabilitation) sessions with a therapist, each lasting 45-60 minutes, 1-2 times per week, over a 12-week intervention period.

DEVICEContinuous Positive Airway Pressure

Participants will use Continuous Positive Airway Pressure (CPAP) throughout the intervention period.


Locations(1)

National Cheng Kung University Hospital

Tainan, Taiwan

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NCT06512779


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