Developement of TipTraQ Home Sleep Test

NCT06474351 | Completed

• 1 other identifier: TipTraQ developement VGH
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The clinical study aims to develop and fine-tune the TipTraQ system, created by PranaQ, for home 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). This open-label, non-randomized study will recruit 240 subjects aged 20 and older from the Veteran General Hospital, Taipei.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (3)

• 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. Usually range from 4 to 10 hours

• 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. Usually range from 4 to 10 hours

• 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. Usually range from 4 to 10 hours

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• PranaQ Pte. Ltd.: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taipei, 201, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 39821673 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 25, 2024
• Study Start: June 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 22, 2024

Record last verified: 2024-10

Locations

TW (1)