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

Sponsor
The University of Hong Kong
Study ID
NCT07663799
Status
Not Yet Recruiting

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Conditions

  • Apple Watch
  • Congenital Heart Disease
  • Coronary Heart Disease (CHD)
  • Heart Failure
  • Pulmonary Hypertension

Eligibility Criteria

Sex
ALL
Age
20 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Apple Watch Series 9 — DEVICE
    Participant will concurrently be wearing the investigational smartwatch for pre- and post-SaO2 and VO2max assessment.

Study Details

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.

Key Dates

First listed
Jun 23, 2026
Start date
Aug 1, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: WatchXP
    Participants will wear the investigational smartwatch (Apple Watch Series 9) concurrently for pre- and post-SaO2 and VO2max assessment during cardiopulmonary exercise test at the visit.

Primary Outcome Measure

Correlation between CPX VO2max and smartwatch parameters (virtual VO2 max, physical activity parameters) [ Time Frame: During treadmill exercise in the day of recruitment and concurrently baseline assessment ]

Central Contacts

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