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

28 augusti 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

400

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

  • Namn: Miao Chen, PHD
  • Telefonnummer: +86 18618230229
  • E-post: chenm@pumch.cn

Studieorter

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100730
        • Peking Union Medical College Hospital
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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 -

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Sensitivity and specificity of the wearable-based deep learning model for binary anemia classification
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Model performance stability under 24-hour continuous wear
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Peking Union Medical College Hospital

Samarbetspartners

Huawei Device Co., Ltd

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

5 september 2026

Primärt slutförande (Beräknad)

30 juni 2027

Avslutad studie (Beräknad)

15 juli 2027

Studieregistreringsdatum

Först inskickad

26 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

28 augusti 2026

Första postat (Faktisk)

1 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • PUMCH-WEAR-ANEMIA-2026

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

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Studerar en amerikansk FDA-reglerad produktprodukt

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