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

Ki vehet részt

• Subjects aged between 20 and 75 years
• 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
• Subjects assessed by healthcare professionals to require polysomnography (PSG) evaluation
• 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
• 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

Ki nem vehet részt

• 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
• Patients taking medications that may interfere with sleep patterns or muscle tone (e.g., sedatives or muscle relaxants) should be excluded from the study
• 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
• 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
• 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
• 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)
• Patients diagnosed with DSM-IV and DSM-V disorders and any other potential emotional issues or psychological history
• Other exclusions as determined by the principal investigator/sleep technician who deems the subject unsuitable for participation in the trial