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Wearable Device-Based Screening for Anemia Risk (WEAR-ANEMIA)

2026年8月28日 更新者：Chen Miao、Peking Union Medical College Hospital

Anemia is a common condition, but it often goes undiagnosed because confirming it requires a venous blood test. This study looks at whether a commercially available wrist-worn smartwatch can help identify people who may have anemia, without taking blood.

The watch continuously records several types of physiological signals, including photoplethysmography (a light-based measure of blood flow), movement, heart rate, blood oxygen saturation, and heart rate variability. Researchers will use these signals to build a computer model that sorts participants into two groups: likely to have anemia, or unlikely to have anemia.

About 400 adults between 18 and 80 years of age will take part at one hospital in Beijing, China. Both patients with anemia and people with normal hemoglobin levels will be included. Each participant will wear the watch and also have a standard venous blood test to measure hemoglobin, which serves as the reference for comparison.

Data from the first 250 participants will be used to develop the model. Data from the next 150 participants will be used to test how well the model works in a separate group. The main question is how accurately the watch-based result matches the blood test result.

調査の概要

状態

まだ募集していません

条件

詳細な説明

This is a prospective, observational, diagnostic accuracy study conducted at a single tertiary care hospital in Beijing, China. The purpose is to develop and evaluate a deep learning model for non-invasive binary classification of anemia using multimodal physiological signals acquired from a commercially available consumer wrist-worn wearable device.

Study procedures. Participants will be enrolled in two sequential stages. In the first stage, 250 participants will be enrolled for algorithm development and tuning. In the second stage, an additional 150 participants will be enrolled for independent testing of the locked model and for supporting iterative optimization. All participants will undergo wearable signal acquisition and venous blood sampling for hemoglobin measurement, which serves as the reference standard.

Signal acquisition differs by care setting. Hospitalized participants will undergo 24-hour continuous wearable monitoring and paired signal acquisition before and after a six-minute walk test. Outpatient participants will undergo short-duration resting acquisition with the device worn alternately on the left and right wrist. Outpatient participants may undergo up to three additional assessments if they return for routine clinical visits; these visits are opportunistic and recorded as they occur. Hospitalized participants undergo a single acquisition without follow-up.

Reference standard. Anemia is defined according to Chinese sea-level criteria: hemoglobin below 120 g/L in adult men, below 110 g/L in non-pregnant women, and below 100 g/L in pregnant women.

Sample size. The primary endpoint is diagnostic sensitivity. Assuming an expected sensitivity of 70%, an allowable error of 6%, and a confidence level of 95%, at least 225 participants with anemia are required. Allowing for approximately 10% dropout or unusable data, the anemia group is set at 300 or more participants. At least 90 participants with normal hemoglobin will be enrolled to estimate specificity. To support deep learning model training and generalizability assessment, the total target enrollment is 400 participants.

Statistical analysis. Model performance will be reported as sensitivity and specificity. Cross-validation will be used to assess model stability, and an independent test set will be used to assess generalizability.

The wearable device is non-invasive. Study participation does not alter any aspect of the clinical management of participants.

研究の種類

観察的

入学 (推定)

400

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Jian Li, Phd
  • 電話番号：010-69155027
  • メール：lijian@pumch.cn

研究連絡先のバックアップ

  • 名前：Miao Chen, PHD
  • 電話番号：+86 18618230229
  • メール：chenm@pumch.cn

研究場所

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100730
        • Peking Union Medical College Hospital
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

サンプリング方法

非確率サンプル

調査対象母集団

Adults aged 18 to 80 years recruited from inpatient wards and outpatient clinics at a single tertiary care hospital in Beijing, China. The population includes both participants with a hospital-confirmed diagnosis of anemia and control participants with hemoglobin within the normal reference range. Anemia is defined according to Chinese sea-level criteria: hemoglobin below 120 g/L in adult men, below 110 g/L in non-pregnant adult women, and below 100 g/L in pregnant women. For participants with anemia, a hemoglobin result obtained within the 3 days and a diagnostic report specifying anemia severity, red blood cell size classification, and anemia type are required. Enrollment targets at least 300 participants with anemia and at least 90 participants with normal hemoglobin. Participants are enrolled consecutively as they present for routine clinical care and meet eligibility criteria.

説明

Inclusion Criteria:

  1. Age 18 to 80 years, any sex
  2. Willing to participate and able to provide written informed consent
  3. Able to comply with wearable device wear, venous blood sampling, and functional assessment (e.g., six-minute walk test)
  4. For participants with anemia: a hemoglobin test result obtained within 3 days before or after wearable signal acquisition and a hospital diagnostic report, including anemia severity, red blood cell size classification, and anemia type. Anemia is defined according to Chinese sea-level criteria: hemoglobin below 120 g/L in adult men, below 110 g/L in non-pregnant adult women, and below 100 g/L in pregnant women
  5. For control participants: hemoglobin within the normal reference range -

Exclusion Criteria:

  1. Axillary temperature 37.3°C or higher on the day of data collection or on the preceding day
  2. Acute exacerbation of a severe comorbid condition (e.g., decompensated heart failure, respiratory failure, acute infection)
  3. Skin breakdown, rash, deformity, amputation, or any other condition of the upper limb precluding proper wear of the device
  4. Refusal of, or intolerance to, invasive venous blood sampling
  5. Concurrent participation in another interventional clinical trial -

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
Model development cohort
First 250 participants. Wearable multimodal physiological signals and venous hemoglobin measurement are collected in parallel and used for deep learning model development and tuning.
Independent validation cohort
Subsequent 150 participants. Data are used for independent testing of the model and to support iterative optimization.

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
Sensitivity and specificity of the wearable-based deep learning model for binary anemia classification
時間枠：Day 1
Agreement between the model-derived anemia versus non-anemia classification and venous hemoglobin measurement as the reference standard. Venous blood sampling is performed within 3 days before or after wearable signal acquisition.Reported as sensitivity and specificity with 95% confidence intervals in the independent validation cohort.
Day 1

二次結果の測定

結果測定
メジャーの説明
時間枠
Model performance stability under 24-hour continuous wear
時間枠：Day 1
Sensitivity and specificity of the model using signals acquired during 24-hour continuous wearable monitoring in hospitalized participants.
Day 1
Effect of red blood cell size classification on model estimation accuracy
時間枠：Day 1
Model sensitivity and specificity stratified by red blood cell size category (microcytic, normocytic, macrocytic) based on mean corpuscular volume
Day 1
Model performance stability under exercise load
時間枠：Day 1 (immediately before and after the six-minute walk test)
Comparison of model classification performance using signals acquired before versus after a six-minute walk test in hospitalized participants.
Day 1 (immediately before and after the six-minute walk test)
Agreement of classification results between left and right wrist placement
時間枠：Day 1
Concordance of the model-derived anemia classification between signals acquired with the device worn on the left wrist and on the right wrist in outpatient participants.
Day 1

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Peking Union Medical College Hospital

協力者

Huawei Device Co., Ltd

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月5日

一次修了 (推定)

2027年6月30日

研究の完了 (推定)

2027年7月15日

試験登録日

最初に提出

2026年8月26日

QC基準を満たした最初の提出物

2026年8月28日

最初の投稿 (実際)

2026年9月1日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月1日

QC基準を満たした最後の更新が送信されました

2026年8月28日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • PUMCH-WEAR-ANEMIA-2026

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?

いいえ

IPD プランの説明

Individual participant data include continuous multimodal physiological signal recordings that are potentially identifiable and cannot be adequately de-identified. Raw data will therefore not be shared with other researchers. Aggregate study results will be reported in peer-reviewed publications and in a study summary report, without any information that could identify individual participants.

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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