Comparing a new jaw tracking device to traditional sleep apnea tests

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Taipei Medical University WanFang Hospital
  Taipei, Taiwan Recruiting

Study contacts

• Study coordinator: Jowy Tani, MD, PhD
• Email: jowytani@gmail.com
• Phone: +886-229307930

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• CES-EES score and a wearable ring for diagnosing obstructive sleep apnea

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.