Wearable Device-Based Screening for Anemia Risk (WEAR-ANEMIA)
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.
연구 개요
상태
상태
정황
정황
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Jian Li, Phd
- 전화번호: 010-69155027
- 이메일: lijian@pumch.cn
연구 연락처 백업
- 이름: Miao Chen, PHD
- 전화번호: +86 18618230229
- 이메일: chenm@pumch.cn
연구 장소
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Beijing Municipality
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Beijing, Beijing Municipality, 중국, 100730
- Peking Union Medical College Hospital
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연락하다:
- Jian Li, Phd
- 전화번호: 010-69155027
- 이메일: lijian@pumch.cn
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Age 18 to 80 years, any sex
- Willing to participate and able to provide written informed consent
- Able to comply with wearable device wear, venous blood sampling, and functional assessment (e.g., six-minute walk test)
- 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
- For control participants: hemoglobin within the normal reference range -
Exclusion Criteria:
- Axillary temperature 37.3°C or higher on the day of data collection or on the preceding day
- Acute exacerbation of a severe comorbid condition (e.g., decompensated heart failure, respiratory failure, acute infection)
- Skin breakdown, rash, deformity, amputation, or any other condition of the upper limb precluding proper wear of the device
- Refusal of, or intolerance to, invasive venous blood sampling
- Concurrent participation in another interventional clinical trial -
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
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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.
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Independent validation cohort
Subsequent 150 participants.
Data are used for independent testing of the model and to support iterative optimization.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Sensitivity and specificity of the wearable-based deep learning model for binary anemia classification
기간: Day 1
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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.
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Day 1
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Model performance stability under 24-hour continuous wear
기간: Day 1
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Sensitivity and specificity of the model using signals acquired during 24-hour continuous wearable monitoring in hospitalized participants.
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Day 1
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Effect of red blood cell size classification on model estimation accuracy
기간: Day 1
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Model sensitivity and specificity stratified by red blood cell size category (microcytic, normocytic, macrocytic) based on mean corpuscular volume
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Day 1
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Model performance stability under exercise load
기간: Day 1 (immediately before and after the six-minute walk test)
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Comparison of model classification performance using signals acquired before versus after a six-minute walk test in hospitalized participants.
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Day 1 (immediately before and after the six-minute walk test)
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Agreement of classification results between left and right wrist placement
기간: Day 1
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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.
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Day 1
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공동 작업자 및 조사자
협력자
협력자
간행물 및 유용한 링크
일반 간행물
- Zhu J, Sun R, Liu H, Wang T, Cai L, Chen Z, Heng B. A Non-Invasive Hemoglobin Detection Device Based on Multispectral Photoplethysmography. Biosensors (Basel). 2023 Dec 30;14(1):0. doi: 10.3390/bios14010022.
- Li L, Luo R, Medina A, Rozelle S. THE PREVALENCE OF ANEMIA IN CENTRAL AND EASTERN CHINA: EVIDENCE FROM THE CHINA HEALTH AND NUTRITION SURVEY. Southeast Asian J Trop Med Public Health. 2015 Mar;46(2):306-21.
- Li M, Hu Y, Mao D, Wang R, Chen J, Li W, Yang X, Piao J, Yang L. Prevalence of Anemia among Chinese Rural Residents. Nutrients. 2017 Feb 24;9(3):192. doi: 10.3390/nu9030192.
- Liu X, Wang B, Man S, Bao H, Huang Y, Yu C, Lyu J, Wang L, Li L, Liu H. Variations in the Prevalence of Anemia of Varying Severity Among Urban Non-Pregnant Women - China, 2021. China CDC Wkly. 2024 Mar 8;6(10):175-180. doi: 10.46234/ccdcw2024.036.
- Shwarz M. Burden of anemia in the United States from 1990 to 2019: a systematic analysis of the Global Burden of Disease Study 2019. Front Public Health. 2025 Oct 3;13:1653222. doi: 10.3389/fpubh.2025.1653222. eCollection 2025.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- PUMCH-WEAR-ANEMIA-2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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