TipTraQ Home Sleep Test Study, SHH

Feasibility Evaluation of Sleep Apnea Screening with Photoplethysmography

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).

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea

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 Type: Observational
• Enrollment (Actual): 112

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 23561
    • Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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, 1 night.
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, 1 night.
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, 1 night.

Collaborators and Investigators

• Sponsor: PranaQ Pte. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): March 27, 2024

Study Registration Dates

• First Submitted: October 2, 2024
• First Submitted That Met QC Criteria: October 7, 2024
• First Posted (Actual): October 9, 2024

Study Record Updates

• Last Update Posted (Actual): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Obstructive Sleep Apnea
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: TipTraQ developement SHH; N202303101 (Other Identifier: TMU-Joint Institutional Review Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No