睡眠時無呼吸スクリーニング用の TipTraQ デバイスの性能を検証する研究
Validation of a Medical-grade Wearable Device With Interpretable Artificial Intelligence System for the Obstructive Sleep Apnea-hypopnea Syndrome (OSAHS) Evaluation
A validation study has been designed to assess the performance of a home sleep test device, TipTraQ, for screening sleep apnea. The study involves participants wearing the TipTraQ device on their fingertip during a traditional sleep test, known as polysomnography (PSG), conducted in a sleep center. The performance of the device will then be evaluated by comparing the results from the TipTraQ system with those from the traditional sleep test.
調査の概要
状態
条件
詳細な説明
This clinical study is designed to validate TipTraQ, a new sleep screening device developed by PranaQ, for the detection of Sleep Breathing Disorders (SBD), including obstructive sleep apnea-hypopnea syndrome (OSAHS). Given the high prevalence of undiagnosed OSAHS and the cumbersome nature of traditional polysomnography (PSG) - which involves multiple sensors and specialist interpretation - there is a pressing need for more accessible screening tools. TipTraQ aims to meet this need through a wearable device that utilizes photoplethysmography (PPG) and an accelerometer to monitor essential physiological parameters during sleep. This information is then analyzed by an interpretable artificial intelligence (AI) system to estimate key indicators of sleep health such as SpO2, total sleep time (TST), oxygen desaturation index (ODI), and apnea-hypopnea index (AHI).
The study is open-label and non-randomized, planning to recruit 125 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 primary goal is to assess the accuracy of the TipTraQ system by comparing its output against the gold standard PSG annotations made by sleep experts.
This initiative represents a significant step towards simplifying and democratizing the screening process for sleep disorders, potentially enabling early detection and treatment for a larger segment of the population, thus mitigating personal health risks and broader societal impacts of undiagnosed SBD.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Taipei
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Taipei、Taipei、台湾、201
- Taipei Veterans General Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Healthy or people who has indication to conduct polysomnography (PSG).
説明
Inclusion Criteria:
Subjects from the age of 20 and older that have an indication for an in-lab PSG study in the Duke University Hospital. 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 anytime.
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 Obstructive Lung Disease, Global Initiative for Chronic Obstructive Lung Disease (GOLD) categorization 3 or 4
- 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 Alzheimers, unconscious by head trauma, or of someone with limited mental capacity Cannot correctly follow the order to use the TipTraQ device
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：CASE_ONLY
- 時間の展望：PROSPECTIVE
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Oxygen Desaturation Index(ODI)
時間枠：From the start of a single polysomnography study to the end of the recording. Time range from 4hour up to 10 hour.
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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. Time range from 4hour up to 10 hour.
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Apnea Hypopnea Index(AHI)
時間枠：From the start of a single polysomnography study to the end of the recording. Time range from 4hour up to 10 hour.
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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. Time range from 4hour up to 10 hour.
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Total Sleep Time(TST)
時間枠：From the start of a single polysomnography study to the end of the recording. Time range from 4hour up to 10 hour.
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Total sleep time during the polysomnography (PSG) |
From the start of a single polysomnography study to the end of the recording. Time range from 4hour up to 10 hour.
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- TipTraQ validation VGH
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
The study collects mostly physiological signal data, not suitable for IPD
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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