Validation of the TipTraQ home sleep test for obstructive sleep apnea
Validation of a Medical-grade Wearable Device with Interpretable Artificial Intelligence System for the Obstructive Sleep Apnea-hypopnea Syndrome (OSAHS) Evaluation
This study is testing a new home sleep device called TipTraQ to see if it can accurately screen for obstructive sleep apnea compared to the standard sleep test done in a sleep center.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 125 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | PranaQ Pte. Ltd. Industry-sponsored |
| Locations | 1 site (Taipei, Taipei) |
| Trial ID | NCT06474390 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the TipTraQ device, a wearable home sleep test designed to screen for obstructive sleep apnea (OSA). Participants will wear the device on their fingertip during a traditional sleep test called polysomnography (PSG) at a sleep center. The performance of TipTraQ will be evaluated by comparing its results with those from PSG, which is considered the gold standard for diagnosing sleep disorders. The study will recruit 125 subjects and utilize artificial intelligence to analyze sleep health indicators.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 20 and older who require an in-lab PSG study for suspected sleep apnea.
Not a fit: Patients with severe heart conditions, chronic obstructive lung disease, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accessible and efficient method for screening obstructive sleep apnea, leading to earlier diagnosis and treatment.
How similar studies have performed: Other studies have shown promise in validating home sleep tests, but the TipTraQ device represents a novel approach in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Subjects from the age of 20 and older that have an indication for an in-lab PSG study in the Duke University Hospital. The subject should be able to understand the study and sign the informed consent before being enrolled in the study. During the study period, the subject can withdraw from the study anytime. Exclusion Criteria: Subjects with the following medical conditions will be excluded from this study: 1. Heart transplant 2. Heart failure, New Youk Heart Association (NYHA) classification III or IV 3. Chronic Obstructive Lung Disease, Global Initiative for Chronic Obstructive Lung Disease (GOLD) categorization 3 or 4 4. Chronic opioid medication user Devastating Severe strokes, with the modified Rankin score (mRS)≥4 5. Tracheostomy 6. Incapable of comprehending and signing the informed consent and questionnaires, including but not limited to subjects with severe Alzheimers, unconscious by head trauma, or of someone with limited mental capacity Cannot correctly follow the order to use the TipTraQ device
Where this trial is running
Taipei, Taipei
- Taipei Veterans General Hospital — Taipei, Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Ke Wei Chen, M.D.
- Email: kwchen@pranaq.com
- Phone: +886-2-77415277
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.