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

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

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

OSA patients

Aged over 20 years

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Control Group

    Other intervention

    sleep hygiene education

  • Surgical Intervention

    Procedure/Surgery

    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.

  • Oropharyngeal Training (face-to-face)

    Other intervention

    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.

  • Oropharyngeal Training (telerehabilitation)

    Other intervention

    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.

  • Continuous Positive Airway Pressure

    Device

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

Treatment groups

150 Participants
are divided into 5 treatment groups
Group A: Control GroupSham comparator 1 intervention
Group B: Surgical InterventionExperimental treatment 1 intervention
Group C: Oropharyngeal Training (face-to-face)Experimental treatment 1 intervention
Group D: Oropharyngeal Training (telerehabilitation )Experimental treatment 1 intervention
Group E: Continuous Positive Airway PressureExperimental 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, 12 weeks, 24 weeks post intervention

Secondary outcomes

1

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)

Time frame
Baseline, 12 weeks, 24 weeks post intervention
2

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).

Time frame
Baseline, 12 weeks, 24 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, 12 weeks, 24 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, 12 weeks, 24 weeks post intervention

Other outcomes

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