Developing a Treatment Clustering System for Obstructive Sleep Apnea Using Polysomnographic Physiological Signals
1 other identifier
interventional
150
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2024
CompletedFirst Posted
Study publicly available on registry
July 22, 2024
CompletedStudy Start
First participant enrolled
July 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedAugust 6, 2024
August 1, 2024
1.5 years
July 16, 2024
August 4, 2024
Conditions
Keywords
Outcome Measures
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.
Baseline, 12 weeks, 24 weeks post intervention
Secondary Outcomes (11)
Tongue muscle strength
Baseline, 12 weeks, 24 weeks post intervention
Tongue muscle endurance
Baseline, 12 weeks, 24 weeks post intervention
Pharyngeal Airway Volume
Baseline, 12 weeks, 24 weeks post intervention
Cross Section Area on the Tip of Epiglottis
Baseline, 12 weeks, 24 weeks post intervention
Anterior to Posterior Distance on the Tip of the Epiglottis
Baseline, 12 weeks, 24 weeks post intervention
- +6 more secondary outcomes
Study Arms (5)
Control Group
SHAM COMPARATORParticipants who are unwilling to undergo surgery, use a mandibular advancement device, utilize continuous positive airway pressure (CPAP) devices, or undergo oropharyngeal training. They will receive sleep hygiene education.
Surgical Intervention
EXPERIMENTALRemove excessive soft tissue from the base of the tongue, soft palate, and/or tonsil.
Oropharyngeal Training (face-to-face)
EXPERIMENTALParticipants 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 )
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants will use Continuous Positive Airway Pressure (CPAP) throughout the intervention period.
Interventions
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.
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.
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.
Participants will use Continuous Positive Airway Pressure (CPAP) throughout the intervention period.
Eligibility Criteria
You may qualify if:
- OSA patients
- Aged over 20 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cheng Kung University Hospital
Tainan, 701, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ching-Hsia Hung, PhD
National Cheng Kung University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2024
First Posted
July 22, 2024
Study Start
July 30, 2024
Primary Completion
January 31, 2026
Study Completion
May 1, 2026
Last Updated
August 6, 2024
Record last verified: 2024-08