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

Taipei Medical University

Status: Enrolling

Conditions: Obstructive Sleep Apnea

Treatments: Device: Ultrasonic Jaw Tracking Device

Study type: Interventional

Funder types: Other

Identifiers

NCT06862297

N202408019

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Subjects aged between 20 and 75 years.
2. Potential sleep apnea cases: individuals referred by healthcare professionals due to suspected sleep apnea. Indicators may include excessive daytime sleepiness, noticeable loud snoring, witnessed apneas, or high-risk assessments on standard sleep 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 the trial procedures. Participants must have the psychological capacity to provide informed consent and comply with study protocols.
5. Subjects agree that the principal investigator and their medical team may review their past medical records and extract sleep apnea-related medical history into the case report form during their participation in the trial, as per the condition or trial needs.

Exclusion criteria

1. Patients currently receiving treatment for sleep apnea (e.g., CPAP therapy or oral appliances) who cannot sleep without these devices or face potential risks without them.
2. Major respiratory risk conditions: including patients with chronic obstructive pulmonary disease (COPD), unstable asthma, or other significant respiratory conditions that may affect the accuracy of sleep study results should be excluded.
3. Patients with unstable cardiac conditions or recent hospitalization related to cardiac issues should be excluded from this clinical trial for the safety of conducting 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 the placement or function of the mandibular tracking device (e.g., noticeable facial hair, dental appliances, or severe dental problems) should be excluded.
6. Individuals with neurological conditions that may affect mandibular muscle control or present symptoms similar to sleep apnea (e.g., Parkinson's disease, severe post-stroke neurological damage).
7. Patients diagnosed with DSM-IV and DSM-V disorders and any other potential emotional issues or psychological history.
8. Other exclusions as determined by the principal investigator/sleep technician who deems the subject unsuitable for participation in the trial.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Concurrent Use of Multiple Polysomnography (PSG) Parameters and a Novel Ultrasonic Jaw Tracking Devi

Experimental group

Treatment:

Device: Ultrasonic Jaw Tracking Device