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CompletedNCT06633887Updated Oct 18, 2024

TipTraQ Home Sleep Test Study, SHH

An observational study in Obstructive Sleep Apnea, sponsored by PranaQ Pte. Ltd.. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-18.

Sponsored by PranaQ Pte. Ltd. · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
112
Ages
20 Years to 80 Years
Sex
All
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Study 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).

Read the 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).

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Conditions studied

  • Obstructive Sleep Apnea

Keywords

  • Obstructive Sleep Apnea
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In context

Sleep Apnea, Obstructive

2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.

This study's enrollment of 112 is close to the median of 105 across 666 observational studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

PranaQ Pte. Ltd. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
112 participants (actual)
Patient registry
No

Groups and cohorts

  • Healthy or people who has indication to conduct polysomnography (PSG).
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What researchers measure

Primary outcomes

  1. Apnea Hypopnea Index(AHI)

    The combined average number of apneas and hypopneas that occur per hour of sleep

    Time frame: From the start of a single polysomnography study to the end of the recording, 1 night.

  2. Oxygen Desaturation Index(ODI)

    Average desaturation episodes with a decrease in the oxygen saturation of ≥4% or 3% per hour

    Time frame: From the start of a single polysomnography study to the end of the recording, 1 night.

  3. Total Sleep Time(TST)

    Total sleep time during the polysomnography (PSG)

    Time frame: From the start of a single polysomnography study to the end of the recording, 1 night.

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Study locations

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

Publications

  • 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. PubMed 39821673 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06633887
Lead sponsor
PranaQ Pte. Ltd.
Responsible party
Sponsor
First posted
Oct 9, 2024
Start date
Mar 1, 2023
Primary completion
Feb 28, 2024
Completion
Mar 27, 2024
Last update
Oct 18, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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