Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06633887
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
TipTraQ Home Sleep Test Study SHH
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility Evaluation of Sleep Apnea Screening with Photoplethysmography
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The clinical study aims to develop and validate the TipTraQ system created by PranaQ a home sleep test for sleep apnea screening The system comprises a wearable device and a cloud-based AI for estimating Total Sleep Time TST and Apnea-Hypopnea Index AHI
Detailed Description:
Sleep-disordered breathing is a common disease that affects life function and quality of life and it also imposes a great burden on the public health system Obstructive sleep apnea accounts for the largest proportion of sleep-disordered breathing and because of the oriental facial structure the prevalence of sleep-disordered breathing is relatively high The current gold standard for diagnosis OSA is polysomnography PSG Although the physiological information collected by PSG is complete and detailed it requires a considerable amount of manpower and medical resources and changes in the sleep environment also cause bias in the accuracy of inspection So far the tools for simple and accurate screening and diagnosis OSA are relatively limited In this study TipTraQ a wearable device developed by PranaQ was used to collect photoplethysmography PPG of patients during the night of PSG inspection The reliability and validity analysis was carried out by comparing with the corresponding indicators of PSG and the feasibility of TipTraQ as a tool for home sleep test HST
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None