Clinical trial NCT06474351: Developement of TipTraQ Home Sleep Test
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Lead sponsor: PranaQ Pte. Ltd.
Sponsor class: INDUSTRY
First posted: 2024-06-25
Enrollment: 240
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health or people who has indication to conduct polysomnography (PSG).

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.

Detailed description: 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.

Eligibility criteria: 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:

1. Heart transplant
2. Heart failure, New Youk Heart Association (NYHA) classification III or IV
3. Chronic opioid medication user Devastating Severe strokes, with the modified Rankin score (mRS)≥4
4. Tracheostomy
5. 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
6. Cannot correctly follow the order to use the TipTraQ device

Primary outcomes:
measure: Apnea Hypopnea Index(AHI)
timeFrame: From the start of a single polysomnography study to the end of the recording. Usually range from 4 to 10 hours
measure: Oxygen Desaturation Index(ODI)
timeFrame: From the start of a single polysomnography study to the end of the recording. Usually range from 4 to 10 hours
measure: Total Sleep Time(TST)
timeFrame: From the start of a single polysomnography study to the end of the recording. Usually range from 4 to 10 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References: