NCT06862297

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

Prospective Study on Concurrent Use of Multiple Polysomnography (PSG) Parameters and a Novel Ultrasonic Jaw Tracking Device in Patients with Sleep Apnea

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Taipei Medical University WanFang Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Ultrasonic Jaw Tracking Device	This study investigates the effectiveness of the Ultrasonic Jaw Tracking Device, a novel non-invasive diagnostic tool designed to monitor dynamic jaw movements during sleep. The device is equipped with advanced ultrasonic sensors and proprietary algorithms to track jaw position and motion in real time. The intervention involves placing the device on the participant's mandible during polysomnography (PSG) sessions to simultaneously measure jaw movement data alongside standard PSG parameters. The primary goal is to evaluate the accuracy and efficacy of the device in detecting sleep-related conditions such as obstructive sleep apnea (OSA) compared to traditional PSG metrics.

Timeline

• Start date: 2024-09-19
• Primary completion: 2025-09-02
• Completion: 2025-09-02
• First posted: 2025-03-06
• Last updated: 2025-03-06

Locations

1 site across 1 country: Taiwan