TipTraQ Home Sleep Test Validation Study, Duke
Validation of a Medical-grade Wearable Device with Interpretable Artificial Intelligence System for the Obstructive Sleep Apnea-hypopnea Syndrome (OSAHS) Screening
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2024
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 28, 2024
CompletedFirst Submitted
Initial submission to the registry
April 2, 2024
CompletedFirst Posted
Study publicly available on registry
April 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 23, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 23, 2024
CompletedOctober 22, 2024
October 1, 2024
6 months
April 2, 2024
October 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Apnea Hypopnea Index(AHI)
The combined average number of apneas and hypopneas that occur per hour of sleep
From the start of a single polysomnography study to the end of the recording.
Oxygen Desaturation Index(ODI)
Average desaturation episodes with a decrease in the oxygen saturation of ≥4% or 3% per hour
From the start of a single polysomnography study to the end of the recording.
Total Sleep Time(TST)
Total sleep time during the polysomnography (PSG)
From the start of a single polysomnography study to the end of the recording.
Eligibility Criteria
Health or people who has indication to conduct polysomnography (PSG).
You may qualify if:
- 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.
You may not qualify if:
- 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 Alzheimer's, unconscious by head trauma, or of someone with limited mental capacity
- Cannot correctly follow the order to use the TipTraQ device
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PranaQ Pte. Ltd.lead
Study Sites (1)
Duke University
Durham, North Carolina, 27705, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2024
First Posted
April 8, 2024
Study Start
February 28, 2024
Primary Completion
August 23, 2024
Study Completion
August 23, 2024
Last Updated
October 22, 2024
Record last verified: 2024-10