Actively Recruiting
Prospective Study Between Polysomnography (PSG) and Novel Ultrasonic Jaw Tracking Device in Patients with Sleep Apnea
Led by Taipei Medical University WanFang Hospital · Updated on 2025-03-06
100
Participants Needed
1
Research Sites
49 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Prospective Study Between Polysomnography (PSG) and Novel Ultrasonic Jaw Tracking Device in Patients with Sleep Apnea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects aged between 20 and 75 years.
- Individuals suspected of sleep apnea referred by healthcare professionals, showing symptoms like excessive daytime sleepiness, loud snoring, witnessed apneas, or high-risk sleep apnea questionnaire results.
- Subjects assessed to require polysomnography evaluation.
- Subjects willing and able to provide informed consent and comply with study procedures.
- Subjects agree to allow review of past medical records related to sleep apnea for the study.
You will not qualify if you...
- Patients currently treated for sleep apnea who cannot sleep safely without treatment devices.
- Patients with major respiratory diseases such as COPD or unstable asthma.
- Patients with unstable cardiac conditions or recent cardiac hospitalizations.
- Patients taking sedatives or muscle relaxants that affect sleep or muscle tone.
- Patients with facial or dental conditions interfering with the jaw tracking device placement.
- Patients with neurological disorders affecting jaw muscle control or mimicking sleep apnea symptoms.
- Patients with DSM-IV or DSM-V psychiatric disorders or psychological histories.
- Other exclusions as determined by the principal investigator or sleep technician.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Taipei Medical University WanFang Hospital
Taipei, Taiwan, 116
Actively Recruiting
Research Team
J
Jowy Tani, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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