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Completed

NCT Number: NCT06633887

TipTraQ Home Sleep Test Study, SHH

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).

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

New Taipei City, Taiwan, 23561

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Apnea Hypopnea Index(AHI)

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

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

  2. Oxygen Desaturation Index(ODI)

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

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

  3. Total Sleep Time(TST)

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

    Total sleep time during the polysomnography (PSG)

Sponsors and collaborators

Lead sponsor

PranaQ Pte. Ltd.

Industry

Registry information

Official study title

Feasibility Evaluation of Sleep Apnea Screening with Photoplethysmography

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 9, 2024
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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