Obstructive Sleep ApneaNCT06862297
Prospective Study Between Polysomnography (PSG) and Novel Ultrasonic Jaw Tracking Device in Patients with Sleep Apnea
A study testing Ultrasonic Jaw Tracking Device in people with Obstructive Sleep Apnea, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Ultrasonic Jaw Tracking Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Sep 2024to 2 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 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 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 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University WanFang Hospital
Taipei, 116
Jowy Tani, MD, PhD, +886-2-29307930 ext. #1523, jowytani@gmail.com
About this study
Official title: Prospective Study on Concurrent Use of Multiple Polysomnography (PSG) Parameters and a Novel Ultrasonic Jaw Tracking Device in Patients with Sleep Apnea
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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Ultrasonic Jaw Tracking Device
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic Jaw Tracking DeviceDevice
This study investigates the effectiveness of the Ultrasonic Jaw Tracking Device, a novel non-invasive diagnostic tool designed to monitor dynamic jaw movements during sleep. The device is equipped with advanced ultrasonic sensors and proprietary algorithms to track jaw position and motion in real time.
The intervention involves placing the device on the participant's mandible during polysomnography (PSG) sessions to simultaneously measure jaw movement data alongside standard PSG parameters. The primary goal is to evaluate the accuracy and efficacy of the device in detecting sleep-related conditions such as obstructive sleep apnea (OSA) compared to traditional PSG metrics.
| Study group | Role | What they receive |
|---|---|---|
| Concurrent Use of Multiple Polysomnography (PSG) Parameters and a Novel Ultrasonic Jaw Tracking Devi | Experimental | Not described Receives: Device: Ultrasonic Jaw Tracking Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Demographic and Anthropometric Data
Collect baseline data of the subjects, including height (in meters), weight (in kilograms), age (in years), and gender; simultaneously calculate BMI (weight (kg)/height² (m²)). Data will be analyzed using descriptive statistics.
Measured: Assessment will be conducted prior to subject enrollment (baseline).
Apnea-Hypopnea Index (AHI) measured by Polysomnography (PSG)
Record the average number of events per hour of sleep during which there is complete cessation of airflow (apnea) and partial reduction of airflow (hypopnea) using PSG. Data will be presented as the mean (events/hour) with standard deviation.
Measured: Measured during the overnight sleep study session at baseline.
Respiratory Disturbance Index (RDI) measured by Polysomnography (PSG)
Record all respiratory disturbance events, including apnea, hypopnea, and other abnormal breathing patterns using PSG. Data will be presented as the mean (events/hour) with standard deviation.
Measured: Measured during the overnight sleep study session at baseline.
ECG-Derived Heart Rate Variability (HRV) Parameters
ECG recordings will be performed concurrently, and heart rate variability indices will be calculated. Data will be presented as the mean with standard deviation.
Measured: Measured during the overnight sleep study session at baseline.
Secondary outcomes (2)
Device Attachment Discomfort
Record the discomfort experienced by subjects during the attachment of the ultrasonic mandibular movement recording device.
Measured: Assessed from the moment of device attachment until 10 minutes post-attachment.
Trial Withdrawal Rate
Calculate the proportion of subjects who withdraw from the trial from the date of enrollment until trial completion (or until withdrawal occurs, whichever comes first).
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start19 Sep 2024
- Primary completion2 Sep 2025 (estimated)
- Study completion2 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jowy Tani, Taipei Medical University WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862297
- Sponsor's protocol ID
- N202408019
- Status last verified
- Mar 2025
- First submitted
- 23 Jan 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on Concurrent Use of Multiple Polysomnography (PSG) Parameters and a Novel Ultrasonic Jaw Tracking Device in Patients with Sleep Apnea
- ClinicalTrials.gov ID
- NCT06862297
- Acronym / sponsor ID
- N202408019
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- 2 Sep 2025 (estimated)
- Study completion
- 2 Sep 2025 (estimated)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Concurrent Use of Multiple Polysomnography (PSG) Parameters and a Novel Ultrasonic Jaw Tracking Devi | Experimental | Device: Ultrasonic Jaw Tracking Device |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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 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 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 be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonic Jaw Tracking DeviceThis study investigates the effectiveness of the Ultrasonic Jaw Tracking Device, a novel non-invasive diagnostic tool designed to monitor dynamic jaw movements during sleep. The device is equipped with advanced ultrasonic sensors and proprietary algorithms to track jaw position and motion in real time. The intervention involves placing the device on the participant's mandible during polysomnography (PSG) sessions to simultaneously measure jaw movement data alongside standard PSG parameters. The primary goal is to evaluate the accuracy and efficacy of the device in detecting sleep-related conditions such as obstructive sleep apnea (OSA) compared to traditional PSG metrics. | Device | Concurrent Use of Multiple Polysomnography (PSG) Parameters and a Novel Ultrasonic Jaw Tracking Devi |
Primary outcome
Baseline Demographic and Anthropometric Data
Time frame: Assessment will be conducted prior to subject enrollment (baseline).
Collect baseline data of the subjects, including height (in meters), weight (in kilograms), age (in years), and gender; simultaneously calculate BMI (weight (kg)/height² (m²)). Data will be analyzed using descriptive statistics.
Apnea-Hypopnea Index (AHI) measured by Polysomnography (PSG)
Time frame: Measured during the overnight sleep study session at baseline.
Record the average number of events per hour of sleep during which there is complete cessation of airflow (apnea) and partial reduction of airflow (hypopnea) using PSG. Data will be presented as the mean (events/hour) with standard deviation.
Respiratory Disturbance Index (RDI) measured by Polysomnography (PSG)
Time frame: Measured during the overnight sleep study session at baseline.
Record all respiratory disturbance events, including apnea, hypopnea, and other abnormal breathing patterns using PSG. Data will be presented as the mean (events/hour) with standard deviation.
ECG-Derived Heart Rate Variability (HRV) Parameters
Time frame: Measured during the overnight sleep study session at baseline.
ECG recordings will be performed concurrently, and heart rate variability indices will be calculated. Data will be presented as the mean with standard deviation.
2 secondary outcomes
Device Attachment Discomfort
Time frame: Assessed from the moment of device attachment until 10 minutes post-attachment.
Trial Withdrawal Rate
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: No
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A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Use a Breathing Machine (PAP) (VESPER-OSA 1)
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Active, not recruitingPhase 3
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Who Are on Positive Airway Pressure Ventilation (PAP) Therapy
Subjects With Moderate-to-severe OSA and Obesity Who Are on PAP Therapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonic Jaw Tracking Device in people with Obstructive Sleep Apnea, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jowy Tani, MD, PhD (+886-229307930 ext. #1523, jowytani@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Demographic and Anthropometric Data (time frame: Assessment will be conducted prior to subject enrollment (baseline).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.