TipTraQ Home Sleep Test Study, SHH

NCT ID: NCT06633887

Last Updated: 2024-10-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 112 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-03-27

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).

Conditions

Obstructive Sleep Apnea

Study Design

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

Study Groups

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

PranaQ Pte. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

New Taipei City, Taiwan, Taiwan

Countries

Taiwan

References

Chen KW, Tseng CH, Lee HC, Liu WT, Chou KT, Wu HT. Validation of a fingertip home sleep apnea testing system using deep learning AI and a temporal event localization analysis. Sleep. 2025 May 12;48(5):zsae317. doi: 10.1093/sleep/zsae317.

Reference Type: DERIVED

PMID: 39821673 (View on PubMed)

Other Identifiers

N202303101

Identifier Type: OTHER

Identifier Source: secondary_id

TipTraQ developement SHH

Identifier Type: -

Identifier Source: org_study_id