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

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.

Study Overview

• Status: Recruiting
• Conditions: Validation of Vital Signs Measured by a Consumer-grade Smartwatch
• Intervention / Treatment: Other: Smartwatch rating scale questionnaire; Device: Garmin Venu 3 or Garmin Venu 4 + Philips Intellivue X2

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ruben Knevels, MSc; Phone Number: +32 89 80 40 29; Email: ruben.knevels@zol.be
• Study Contact Backup: Name: Femke Wouters, PhD; Phone Number: +32 89 80 40 32; Email: femke.wouters@zol.be

Study Locations

• Belgium
  • Genk, Belgium, 3600
    • Recruiting
    • Ziekenhuis Oost-Limburg
    • Principal Investigator: David Ruttens, MD, PhD
    • Contact: Future Health; Phone Number: +32 89 80 40 10; Email: futurehealth@zol.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Provide signed and dated informed consent
• Adults older than 18 years of age
• Speak and understand the Dutch language
• Hospitalized for at least another 24 hours

Exclusion Criteria:

• Life expectancy is less than 30 days
• Patient is isolated due to infection control

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients admitted to the pulmonology ward; Patients admitted to the pulmonology ward of Ziekenhuis Oost-Limburg, Genk, Belgium.

Other: Smartwatch rating scale questionnaire; Upon completion of the monitoring period, participants will be asked to complete the Smartwatch Rating Scale (SRS) questionnaire; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean absolute difference between the Garmin Venu 3 / Garmin Venu 4 and a hospital-grade monitor in measuring heart rate up to 24 hours.	For heart rate, the mean absolute difference will be calulated between the measurements performed with the Garmin Venu 3 / Garmin Venu 4 and the measurements performed with the Philips Intellivue X2	From enrollment to the end of treatment at 24 hours
Mean absolute difference between the Garmin Venu 3 / Garmin Venu 4 and a hospital-grade monitor in measuring respiratory rate up to 24 hours.	For respiratory rate, the mean absolute difference will be calculated between the measurements performed with the Garmin Venu 3 / Garmin Venu 4 and the measurements performed with the Philips IntelliVue X2	From enrollment to the end of treatment at 24 hours
Mean absolute difference between the Garmin Venu 3 / Garmin Venu 4 and a hospital-grade monitor in measuring peripheral oxygen saturation up to 24 hours.	For peripheral oxygen satuation (SpO2), the mean absolute difference will be calculated between the measurements performed with the Garmin Venu 3 / Garmin Venu 4 and the measurements performed with the Philips IntelliVue X2.	From enrollment to the end of treatment at 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of artefacts during measurements performed when the participant is awake vs measurements performed when the participant is asleep (expressed in % measurements)	Measurements reported as a '0' due to the inability of the device to perform a correct measurement will be labeled as false.	From enrollment to the end of treatment at 24 hours
User experience of the Garmin Venu 3 / Garmin Venu 4 as measured by the Smartwatch Rating Scale	User experience of the Garmin Venu 3 / Garmin Venu 4 as measured by the Smartwatch Rating Scale	From enrollment to the end of treatment at 24 hours
Time to detection of a sudden drop in SpO2 or clinical deterioration measured by the Garmin Venu 3 / Garmin Venu 4 vs a hospital-grade monitor	In the event of patient deterioration, changes may be reflected in SpO2 levels. This endpoint will evaluate the time taken by the Garmin Venu 3 / Garmin Venu 4 compared to a hospital-grade monitor to detect such changes.	From enrollment to the end of treatment at 24 hours

Collaborators and Investigators

• Sponsor: Ziekenhuis Oost-Limburg

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: September 22, 2025
• First Submitted That Met QC Criteria: January 16, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Accuracy; Garmin; Heart rate; Respiratory rate; Vital signs; Peripheral Oxygen Saturation (SpO2)
• Other Study ID Numbers: Z-2025082; CIV-25-07-053536 (Other Identifier: EUDAMED)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Raw data regarding the vital parameter measurements with other researchers
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No