Developement of TipTraQ Home Sleep Test

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.

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Taipei Veterans General Hospital

Taipei, 201, Taiwan

About this study

Sleep Breathing Disorders (SBD) is a common disorder in the population. However, a lot of patients are not aware of this disease and do not receive proper treatment, which not only impacts their personal health but also causes public disasters. Thus, a screening tool to find those patients becomes a critical point-of-care issue. To achieve this goal, a wearable device that is suitable for the screening is needed. The goal of this study is developing and fine-tuning a new sleep screening platform, TipTraQ, developed by PranaQ. TipTraQ is composed of a wearable device designed as a convenient screening device based on the photoplethysmography (PPG) technique and an interpretable artificial intelligent (AI) system that takes the PPG signal recorded by the wearable device as input and outputs and outputs estimated total sleep time (TST) and apnea-hypopnea index (AHI).

The study is open-label and non-randomized, planning to recruit 240 subjects. Participants will use the TipTraQ device alongside a companion mobile app, with data analysis supported by AI technology hosted on a cloud server. The TipTraQ device will be worn over fingertip. The primary goal is to assess the robustness of the TipTraQ system and fine-tuned the algorithm by comparing its output against the gold standard PSG annotations made by sleep experts.

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. 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Apnea Hypopnea Index(AHI)

Time frame: From the start of a single polysomnography study to the end of the recording. Usually range from 4 to 10 hours

the combined average number of apneas and hypopneas that occur per hour of sleep
Oxygen Desaturation Index(ODI)

Time frame: From the start of a single polysomnography study to the end of the recording. Usually range from 4 to 10 hours

Average desaturation episodes with a decrease in the oxygen saturation of ≥4% or 3% per hour
Total Sleep Time(TST)

Time frame: From the start of a single polysomnography study to the end of the recording. Usually range from 4 to 10 hours

Total sleep time during the polysomnography (PSG)

Sponsors and collaborators

Lead sponsor

PranaQ Pte. Ltd.

Industry

Registry information

Official study title

Development and Fine-tuning of a Medical-grade Wearable Device with Interpretable Artificial Intelligence System for the Obstructive Sleep Apnea-hypopnea Syndrome (OSAHS) Screening

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Jun 25, 2024
Registry last updated: Oct 22, 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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Completed