Comparing a new jaw tracking device to traditional sleep apnea tests

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

This study is testing a new jaw tracking device to see if it can diagnose sleep apnea just as well as traditional sleep tests, making it easier and cheaper for patients.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 20 Years to 75 Years
• Sex: All
• Sponsor: Taipei Medical University WanFang Hospital (Academic / other)
• Locations: 1 site (Taipei)
• Trial ID: NCT06862297 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a novel ultrasonic jaw tracking device for diagnosing obstructive sleep apnea (OSA) compared to traditional polysomnography (PSG). The study aims to provide a more accessible and cost-effective method for monitoring jaw movements during sleep, utilizing smartphone technology to capture data. Participants will include individuals suspected of having sleep apnea, who will be monitored using this innovative device. The goal is to determine if this new approach can deliver similar diagnostic accuracy as PSG while being more convenient for patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 20 to 75 who are suspected of having sleep apnea and require evaluation.

Not a fit: Patients currently receiving treatment for sleep apnea may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more accessible and cost-effective method for diagnosing sleep apnea, improving patient outcomes.

How similar studies have performed: While traditional PSG is well-established, the use of novel ultrasonic devices for sleep apnea diagnosis is relatively new and has shown promise but lacks extensive prior validation.

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.

Where this trial is running

Taipei

• Taipei Medical University WanFang Hospital — Taipei, Taiwan (Recruiting)

Study contacts

• Study coordinator: Jowy Tani, MD, PhD

Conditions Obstructive Sleep Apnea