TipTraQ Home Sleep Test Validation Study, Duke

NCT ID: NCT06351878

Last Updated: 2024-10-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-28
• Study Completion Date: 2024-08-23

Brief 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.

Detailed Description

This clinical study is designed to validate TipTraQ, a new sleep screening device developed by PranaQ, for the detection of Sleep Breathing Disorders (SBD), including obstructive sleep apnea-hypopnea syndrome (OSAHS). Given the high prevalence of undiagnosed OSAHS and the cumbersome nature of traditional polysomnography (PSG) - which involves multiple sensors and specialist interpretation - there is a pressing need for more accessible screening tools. TipTraQ aims to meet this need through a wearable device that utilizes photoplethysmography (PPG) and an accelerometer to monitor essential physiological parameters during sleep. This information is then analyzed by an interpretable artificial intelligence (AI) system to estimate key indicators of sleep health such as SpO2, total sleep time (TST), oxygen desaturation index (ODI), and apnea-hypopnea index (AHI).

The study is open-label and non-randomized, planning to recruit 125 subjects. Participants will use the TipTraQ device alongside a companion mobile app, with data analysis supported by AI technology hosted on a cloud server. The primary goal is to assess the accuracy of the TipTraQ system by comparing its output against the gold standard PSG annotations made by sleep experts.

This initiative represents a significant step towards simplifying and democratizing the screening process for sleep disorders, potentially enabling early detection and treatment for a larger segment of the population, thus mitigating personal health risks and broader societal impacts of undiagnosed SBD.

Conditions

Obstructive Sleep Apnea

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility 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 Alzheimer's, unconscious by head trauma, or of someone with limited mental capacity

7. Cannot correctly follow the order to use the TipTraQ device

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

PranaQ Pte. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Duke University

Durham, North Carolina, United States

Countries

United States

Other Identifiers

TipTraQ validation Duke

Identifier Type: -

Identifier Source: org_study_id