NCT07360678

Comparing the Garmin Venu 3 / Garmin Venu 4 for Non-Invasive Vital Sign Monitoring to a Hospital-Grade Monitor

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Ziekenhuis Oost-Limburg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial evaluates the accuracy of the Garmin Venu 3 / Garmin Venu 4 smartwatch in measuring vital signs (heart rate, respiratory rate, SpO₂) compared to the clinically validated Philips IntelliVue X2. The study aims to determine whether the consumer-grade smartwatch can provide reliable data for remote patient monitoring, early hospital discharge, and chronic disease management, offering a more accessible and affordable alternative to MDR-certified devices.

Detailed description

Wearable technology has rapidly evolved from fitness tracking tools to potential clinical-grade devices capable of non-invasive monitoring of vital signs. Among these, smartwatches equipped with optical sensors and accelerometers now offer continuous measurements of parameters such as heart rate, respiratory rate, and blood oxygen saturation (SpO2). The Garmin Venu 3 / Garmin Venu 4 represent a new generation of commercially available smartwatches that provide vital sign monitoring outside of controlled medical environments. Despite their growing popularity and technological advancements, the clinical validity of smartwatches remains unknown. Applying for medical device regulation (MDR) certification is a long and expensive process, something not all companies can or want to invest in. Besides, the devices that are MDR certified are often very expensive, something not possible to use in an average patient population without extensive funding. For the use of (non-MDR certified) smartwatches into clinical workflows or remote patient monitoring systems, these devices must demonstrate accuracy and reliability comparable to gold-standard hospital-grade monitors. The Philips IntelliVue X2 is a widely used and clinically validated multi-parameter patient monitoring system employed in acute care setting. It provides high-fidelity, real-time monitoring of vital signs and serves as an appropriate benchmark for evaluating the performance of customer-grade devices. Comparing measurements obtained with the Garmin Venu 3 / Garmin Venu 4 against the IntelliVue X2 is essential to determine whether the smartwatch can serve as a reliable tool for continuous vital sign tracking in real-world clinical scenarios. This is particularly relevant for use cases such as early hospital discharge, remote patient monitoring and chronic disease management where accessibility, affordability, convenience and user compliance are critical. This clinical trial seeks to assess the agreement and accuracy of the Garmin Venu 3 / Garmin Venu 4 in measuring key physiological parameters such as heart rate, respiratory rate, and SpO2 compared to the Philips Intellivue X2 in a diverse patient population. Demonstrating clinical equivalence or acceptable accuracy margins would support the potential use of the Garmin Venu 3 / Garmin Venu 4 in remote or supplemental monitoring roles within modern (hybrid) healthcare systems.

Conditions

• Validation of Vital Signs Measured by a Consumer-grade Smartwatch

Interventions

Type	Name	Description
DEVICE	Garmin Venu 3 or Garmin Venu 4 + Philips Intellivue X2	Each participant will be continuously monitored for a minimum of one full night and up to a maximum of 24 hours using both a hospital-grade monitor (Philips IntelliVue X2) and a Garmin Venu 3 or Garmin Venu 4 smartwatch.
OTHER	Smartwatch rating scale questionnaire	Upon completion of the monitoring period, participants will be asked to complete the Smartwatch Rating Scale (SRS) questionnaire

Timeline

• Start date: 2025-10-12
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2026-01-22
• Last updated: 2026-02-24

Locations

1 site across 1 country: Belgium