A validation study has been designed to assess the performance of a home sleep test device, TipTraQ, for screening sleep apnea. The study involves participants wearing the TipTraQ device on their fingertip during a traditional sleep test, known as polysomnography (PSG), conducted in a sleep center. The performance of the device will then be evaluated by comparing the results from the TipTraQ system with those from the traditional sleep test.
Eligibility
Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Oxygen Desaturation Index(ODI) — From the start of a single polysomnography study to the end of the recording. Time range from 4hour up to 10 hour. Average desaturation episodes with a decrease in the oxygen saturation of ≥4% or 3% per hour
Apnea Hypopnea Index(AHI) — From the start of a single polysomnography study to the end of the recording. Time range from 4hour up to 10 hour. The combined average number of apneas and hypopneas that occur per hour of sleep
Total Sleep Time(TST) — From the start of a single polysomnography study to the end of the recording. Time range from 4hour up to 10 hour. Total sleep time during the polysomnography (PSG)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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