Validation of Vital Signs Measured by a Consumer-grade Smartwatch
Conditions
Keywords
Vital signs, Garmin, Accuracy, Heart rate, Respiratory rate, Peripheral Oxygen Saturation (SpO2)
Brief 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.
Interventions
DEVICEGarmin 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.
OTHERSmartwatch rating scale questionnaire
Upon completion of the monitoring period, participants will be asked to complete the Smartwatch Rating Scale (SRS) questionnaire
Sponsors
Ziekenhuis Oost-Limburg
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
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. Recruitment will take place within the pneumology ward. Upon completion of the monitoring period, participants will be asked to complete the Smartwatch Rating Scale (SRS) questionnaire to assess their experience with the smartwatch.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean absolute difference between the Garmin Venu 3 / Garmin Venu 4 and a hospital-grade monitor in measuring heart rate up to 24 hours. | From enrollment to the end of treatment at 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 |
| Mean absolute difference between the Garmin Venu 3 / Garmin Venu 4 and a hospital-grade monitor in measuring respiratory rate up to 24 hours. | From enrollment to the end of treatment at 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 |
| 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. | From enrollment to the end of treatment at 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | User experience of the Garmin Venu 3 / Garmin Venu 4 as measured by the Smartwatch Rating Scale |
| Number of artefacts during measurements performed when the participant is awake vs measurements performed when the participant is asleep (expressed in % measurements) | From enrollment to the end of treatment at 24 hours | Measurements reported as a '0' due to the inability of the device to perform a correct measurement will be labeled as false. |
| 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 | From enrollment to the end of treatment at 24 hours | 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. |
Countries
Belgium
Outcome results
None listed