Validation of Vital Signs Measured by a Consumer-grade SmartwatchGARMINNCT07360678
Comparing the Garmin Venu 3 / Garmin Venu 4 for Non-Invasive Vital Sign Monitoring to a Hospital-Grade Monitor
A study testing Garmin Venu 3 or Garmin Venu 4 + Philips Intellivue X2 and Smartwatch rating scale questionnaire in people with Validation of Vital Signs Measured by a Consumer-grade Smartwatch, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Validation of Vital Signs Measured by a Consumer-grade Smartwatch
- What is being tested?
- Garmin Venu 3 or Garmin Venu 4 + Philips Intellivue X2 and Smartwatch rating scale questionnaire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Oct 2025to 10 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Life expectancy is less than 30 days
- Patient is isolated due to infection control
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Garmin Venu 3 or Garmin Venu 4 + Philips Intellivue X2, Smartwatch rating scale questionnaire
- Keywords
- Vital signs, Garmin, Accuracy, Heart rate, Respiratory rate, Peripheral Oxygen Saturation (SpO2)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Garmin Venu 3 or Garmin Venu 4 + Philips Intellivue X2Device
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.
Smartwatch rating scale questionnaireOther
Upon completion of the monitoring period, participants will be asked to complete the Smartwatch Rating Scale (SRS) questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Patients admitted to the pulmonology ward | Experimental | Patients admitted to the pulmonology ward of Ziekenhuis Oost-Limburg, Genk, Belgium. Receives: Device: Garmin Venu 3 or Garmin Venu 4 + Philips Intellivue X2; Other: Smartwatch rating scale questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: From enrollment to the end of treatment at 24 hours
Secondary outcomes (3)
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
Measured: From enrollment to the end of treatment at 24 hours
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.
Measured: 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.
Measured: From enrollment to the end of treatment at 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start12 Oct 2025
- Primary completion10 Apr 2026
- Study completion10 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Validation of Vital Signs Measured by a Consumer-grade SmartwatchStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Ruttens, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360678
- Sponsor's protocol ID
- Z-2025082
- Other IDs
- CIV-25-07-053536
- Acronym
- GARMIN
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw data regarding the vital parameter measurements with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Garmin Venu 3 / Garmin Venu 4 for Non-Invasive Vital Sign Monitoring to a Hospital-Grade Monitor
- ClinicalTrials.gov ID
- NCT07360678
- Acronym / sponsor ID
- GARMIN / Z-2025082
- Keywords
- Vital signs, Garmin, Accuracy, Heart rate, Respiratory rate, Peripheral Oxygen Saturation (SpO2)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Study start
- 12 Oct 2025 (actual)
- Primary completion
- 10 Apr 2026 (actual)
- Study completion
- 10 Apr 2026 (actual)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients admitted to the pulmonology ward | Experimental | Device: Garmin Venu 3 or Garmin Venu 4 + Philips Intellivue X2, Other: Smartwatch rating scale questionnairePatients admitted to the pulmonology ward of Ziekenhuis Oost-Limburg, Genk, Belgium. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Life expectancy is less than 30 days
- Patient is isolated due to infection control
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Garmin Venu 3 or Garmin Venu 4 + Philips Intellivue X2Each 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. | Device | Patients admitted to the pulmonology ward |
| Smartwatch rating scale questionnaireUpon completion of the monitoring period, participants will be asked to complete the Smartwatch Rating Scale (SRS) questionnaire | Other | Patients admitted to the pulmonology ward |
Primary outcome
Mean absolute difference between the Garmin Venu 3 / Garmin Venu 4 and a hospital-grade monitor in measuring heart rate up to 24 hours.
Time frame: 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.
Time frame: 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.
Time frame: 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.
3 secondary outcomes
User experience of the Garmin Venu 3 / Garmin Venu 4 as measured by the Smartwatch Rating Scale
Time frame: From enrollment to the end of treatment at 24 hours
Number of artefacts during measurements performed when the participant is awake vs measurements performed when the participant is asleep (expressed in % measurements)
Time frame: 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
Time frame: From enrollment to the end of treatment at 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: Yes. Raw data regarding the vital parameter measurements with other researchers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Garmin Venu 3 or Garmin Venu 4 + Philips Intellivue X2 and Smartwatch rating scale questionnaire in people with Validation of Vital Signs Measured by a Consumer-grade Smartwatch, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean absolute difference between the Garmin Venu 3 / Garmin Venu 4 and a hospital-grade monitor in measuring heart rate up to 24 hours. (time frame: From enrollment to the end of treatment at 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.