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Wearable Assessment of Thoracic, Cardiac Health and Exercise Performance Trial Prospective

NCT07663799 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2026-06-23

No results posted yet for this study

Summary

Wearable health technology, particularly smartwatches, has revolutionized personal health monitoring by enabling continuous, non-invasive tracking of various physiological parameters. The potential applications of these devices in cardiology are extensive, but it is crucial to validate their accuracy against established medical-grade devices.

The Apple Watch Series 9 (Apple, USA) exemplifies the capabilities of modern smartwatches, offering a wide range of health tracking features. These include heart rate monitoring, detection of irregular heart rhythms suggestive of atrial fibrillation, electrocardiogram recording, blood oxygen level measurement, and comprehensive mobility metrics (including VO2 max, six-minute walk distance, walking speed, step length, double support time, and walking asymmetry). Many of these parameters are highly relevant for cardiovascular patients, potentially aiding in disease progression monitoring and adverse event prediction. However, there is a lack of comprehensive validation studies for these devices in specific cardiovascular disease populations.

This investigator-initiated, prospective observational study will consist of two phases: a training phase which involves 50 participants and a prospective validation phase which involves 20 participants. The study aims to validate smartwatch-based assessments using medical-grade devices and techniques. The study will focus on adult patients with congenital heart disease, pulmonary hypertension, heart failure, and coronary artery disease, as well as athletes undergoing cardiovascular assessment. By comparing smartwatch data with established clinical measurements, we seek to determine the reliability and potential clinical utility of these wearable devices in diverse cardiovascular contexts. Anonymized smartwatch data collected during the two phases will be published to a publicly registry to facilitate further research. This research will help bridge the gap between consumer-grade wearable technology and clinical practice in cardiology.

Conditions

Interventions

DEVICE

Apple Watch Series 9

Participant will concurrently be wearing the investigational smartwatch for pre- and post-SaO2 and VO2max assessment.

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-12-31
Completion
2028-12-31
FDA Device
Yes

Countries

  • Hong Kong

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07663799 on ClinicalTrials.gov