Clinical trial for Obstructive Sleep Apnea
Official title Prospective Study Between Polysomnography (PSG) and Novel Ultrasonic Jaw Tracking Device in Patients with Sleep Apnea
ClinicalTrials.gov ID: NCT06862297
What this study is testing
- What it's testing
- The study will see how well the ultrasonic device detects apnea compared with the standard overnight sleep study (polysomnography).
- Who it's for
- Adults who have been diagnosed with obstructive sleep apnea.
- What's involved
- Participants will wear the ultrasonic jaw‑tracking sensor while sleeping at home, use their smartphone to record the data, and also undergo a standard sleep study in a clinic.
- Time commitment
- The study involves a few nights of home monitoring and one clinic visit for the sleep study and follow‑up.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 75. Healthy volunteers may be eligible.
You may be able to join if
- people aged between 20 and 75 years.
- Potential sleep apnea cases: individuals referred by healthcare professionals due to suspected sleep apnea.
- people assessed by healthcare professionals to require polysomnography (PSG) evaluation.
- people willing to sign the informed consent form and have been informed about the trial procedures.
- people agree that the principal investigator and their medical team may review their past medical records and extract sleep apnea-related medical...
You likely can't join if
- Patients currently receiving treatment for sleep apnea (e.g., CPAP therapy or oral appliances) who cannot sleep without these devices or face...
- Major respiratory risk conditions: including patients with chronic obstructive pulmonary disease (COPD), unstable asthma, or other significant...
- Patients with unstable cardiac conditions or recent hospitalization related to cardiac issues should be excluded from this clinical trial for the...
- Patients taking medications that may interfere with sleep patterns or muscle tone (e.g., sedatives or muscle relaxants) should be excluded from the...
- Patients with physical abnormalities or conditions that may interfere with the placement or function of the mandibular tracking device (e.g...
- Individuals with neurological conditions that may affect mandibular muscle control or present symptoms similar to sleep apnea (e.g., Parkinson's...
See the full eligibility criteria
- people aged between 20 and 75 years.
- Potential sleep apnea cases: individuals referred by healthcare professionals due to suspected sleep apnea.
- people assessed by healthcare professionals to require polysomnography (PSG) evaluation.
- people 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.
- people 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...
- 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.
- 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...
- 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 taking medications that may interfere with sleep patterns or muscle tone (e.g., sedatives or muscle relaxants) should be excluded from the study.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Taipei, Taiwan. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.