TipTraQ Home Sleep Test Study, SHH

PranaQ

Status: Completed

Conditions: Obstructive Sleep Apnea

Study type: Observational

Funder types: Industry

Identifiers

NCT06633887

TipTraQ developement SHH

N202303101 (Other Identifier)

Details and patient eligibility

About

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).

Full 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).

Enrollment: 112 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Subjects from the age of 20 and older that have an indication for an in-lab PSG study.

Exclusion criteria

• Heart transplant
• Heart failure, New Youk Heart Association (NYHA) classification III or IV
• 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

Trial design

112 participants in 1 patient group

Healthy or people who has indication to conduct polysomnography (PSG).