RecruitingNCT06474390

TipTraQ Home Sleep Test Validation Study, VGH

Validation of a Medical-grade Wearable Device with Interpretable Artificial Intelligence System for the Obstructive Sleep Apnea-hypopnea Syndrome (OSAHS) Evaluation

Sponsor

PranaQ Pte. Ltd.

Enrollment

125 participants

Start Date

Jun 1, 2024

Study Type

OBSERVATIONAL

Conditions

Obstructive Sleep Apnea

Summary

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

Min Age: 20 Years

Inclusion Criteria1

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 Criteria7

Subjects with the following medical conditions will be excluded from this study:
Heart transplant
Heart failure, New Youk Heart Association (NYHA) classification III or IV
Chronic Obstructive Lung Disease, Global Initiative for Chronic Obstructive Lung Disease (GOLD) categorization 3 or 4
Chronic opioid medication user Devastating Severe strokes, with the modified Rankin score (mRS)≥4
Tracheostomy
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

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