Prospective Study Between Polysomnography (PSG) and Novel Ultrasonic Jaw Tracking Device in Patients with Sleep Apnea

Last updated: March 2, 2025
Sponsor: Taipei Medical University WanFang Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sleep Apnea Syndromes

Treatment

Ultrasonic Jaw Tracking Device

Clinical Study ID

NCT06862297
N202408019
  • Ages 20-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Obstructive sleep apnea (OSA) affects over 936 million adults worldwide, leading to significant morbidity and reduced quality of life. Traditional diagnostic methods such as polysomnography (PSG), although effective, rely on hospital equipment and human resources and are not widely accessible. Emerging technologies such as the jaw tracking device developed by Sunrise have appeared, using gyroscopes and accelerometers to monitor jaw movements during sleep, showing high diagnostic accuracy compared to PSG. These devices use AI algorithms, providing a practical alternative for OSA diagnosis and monitoring. However, due to the high hardware cost of Sunrise and its rental-based business model, there are logistical challenges and limited monitoring capabilities. This prospective clinical study aims to offer the same capabilities through a novel ultrasonic transmitter for tracking jaw movements during sleep, which can be directly received by using a smartphone microphone, reducing the complexity of setup operations. This study will evaluate the sensitivity of the ultrasonic jaw tracking device in detecting apnea and compare it with PSG standards, developing a deep learning AI-driven algorithm to analyze data from jaw movements, breathing sounds, and apnea-related arousal events, as a basis for continuous home monitoring and evaluation of treatment effects for OSA patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects aged between 20 and 75 years.

  2. Potential sleep apnea cases: individuals referred by healthcare professionals due tosuspected sleep apnea. Indicators may include excessive daytime sleepiness,noticeable loud snoring, witnessed apneas, or high-risk assessments on standardsleep apnea screening questionnaires.

  3. Subjects assessed by healthcare professionals to require polysomnography (PSG)evaluation.

  4. Subjects willing to sign the informed consent form and have been informed about thetrial procedures. Participants must have the psychological capacity to provideinformed consent and comply with study protocols.

  5. Subjects agree that the principal investigator and their medical team may reviewtheir past medical records and extract sleep apnea-related medical history into thecase report form during their participation in the trial, as per the condition ortrial needs.

Exclusion

Exclusion Criteria:

  1. Patients currently receiving treatment for sleep apnea (e.g., CPAP therapy or oralappliances) who cannot sleep without these devices or face potential risks withoutthem.

  2. Major respiratory risk conditions: including patients with chronic obstructivepulmonary disease (COPD), unstable asthma, or other significant respiratoryconditions that may affect the accuracy of sleep study results should be excluded.

  3. Patients with unstable cardiac conditions or recent hospitalization related tocardiac issues should be excluded from this clinical trial for the safety ofconducting sleep assessments.

  4. Patients taking medications that may interfere with sleep patterns or muscle tone (e.g., sedatives or muscle relaxants) should be excluded from the study.

  5. Patients with physical abnormalities or conditions that may interfere with theplacement or function of the mandibular tracking device (e.g., noticeable facialhair, dental appliances, or severe dental problems) should be excluded.

  6. Individuals with neurological conditions that may affect mandibular muscle controlor present symptoms similar to sleep apnea (e.g., Parkinson's disease, severepost-stroke neurological damage).

  7. Patients diagnosed with DSM-IV and DSM-V disorders and any other potential emotionalissues or psychological history.

  8. Other exclusions as determined by the principal investigator/sleep technician whodeems the subject unsuitable for participation in the trial.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Ultrasonic Jaw Tracking Device
Phase:
Study Start date:
September 19, 2024
Estimated Completion Date:
September 02, 2025

Connect with a study center

  • Taipei Medical University WanFang Hospital

    Taipei, 116
    Taiwan

    Active - Recruiting

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