Clinical trial NCT06862297: Prospective Study Between Polysomnography (PSG) and Novel Ultrasonic Jaw Tracking Device in Patients with Sleep Apnea
Official title: Prospective Study on Concurrent Use of Multiple Polysomnography (PSG) Parameters and a Novel Ultrasonic Jaw Tracking Device in Patients with Sleep Apnea
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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 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.

Primary outcomes:
measure: Baseline Demographic and Anthropometric Data
timeFrame: Assessment will be conducted prior to subject enrollment (baseline).
measure: Apnea-Hypopnea Index (AHI) measured by Polysomnography (PSG)
timeFrame: Measured during the overnight sleep study session at baseline.
measure: Respiratory Disturbance Index (RDI) measured by Polysomnography (PSG)
timeFrame: Measured during the overnight sleep study session at baseline.
measure: ECG-Derived Heart Rate Variability (HRV) Parameters
timeFrame: Measured during the overnight sleep study session at baseline.
Secondary outcomes:
measure: Device Attachment Discomfort
timeFrame: Assessed from the moment of device attachment until 10 minutes post-attachment.
measure: Trial Withdrawal Rate
timeFrame: Assessed from the date of enrollment until trial completion, over an estimated period of up to 41 weeks (i.e., from 2024/09/19 to 2025/06/30).
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University WanFang Hospital
Study officials:
References: