CompletedNo phase
TipTraQ Home Sleep Test Validation Study, Duke
Key facts
- Who runs it
- PranaQ Pte. Ltd.
- Where
- Durham, United StatesSee the site
- Trial code
- Status
- Completed
- People taking part
- 200 people enrolled
- Started
- 28 Feb 2024
- Ended
- 23 Aug 2024
- Type of study
- Observational
- Record updated
- 22 October 2024
Who can take part
- Age
- 20 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- Chronic opioid medication user Devastating Severe strokes, with the modified Rankin score (mRS)≥4
- 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
- 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
Where in United States
- Duke UniversityDurham, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Validation of a Medical-grade Wearable Device with Interpretable Artificial Intelligence System for the Obstructive Sleep Apnea-hypopnea Syndrome (OSAHS) Screening
- Record updated
- 22 October 2024