HeartDarwinNCT06439511
Comparison of a Non Contact Vital Signs Application With Traditional Pulse Oximetry for Heart Rate Measurement
A study testing Darwin smartphone app and Pulse oxymetry in people with Heart, run by Hôpital du Valais at 1 site in Switzerland.
Trial summary
The investigators want to test the accuracy of the Smartphone application Darwin Edge rVSM in measuring heart rate, as compared to traditional pulsoxymetry. The intervention is to look at the smartphone camera for approximately 30 seconds, and after that to compare the heart rate value with that obtained with a… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart
- What is being tested?
- Darwin smartphone app and Pulse oxymetry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2024to 31 Oct 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women older than 18 years old presenting to the preanesthetic assessment clinic of Valais Hospital
- Subjects that have signed the informed consent form
Who cannot join
- subjects with damaged/injured skin at the face
- Subjects unable to remain still for 30 seconds
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of a Non Contact Vital Signs Application (Darwin Edge rVSM) on a Smartphone With Traditional Pulse Oximetry for Heart Rate Measurement: a Prospective Clinical Study
The investigators want to test the accuracy of the Smartphone application Darwin Edge rVSM in measuring heart rate, as compared to traditional pulsoxymetry. The intervention is to look at the smartphone camera for approximately 30 seconds, and after that to compare the heart rate value with that obtained with a recording by pulsoxymetry.
Read the detailed description
Participants undergoing a routine perianesthetic consultation at the preanesthetic clinic will be recruited. as a part of routine clinical assessment their heart rate is measured with pulsoxymetry, a non invasive device worn at the fingertip for about 1 minute. this measurement will be compared to the values for heart rate that can be obtaine with the ''Darwin Edge rVSM'' mobile application. this application can be installed on any smartphone. the participant is required to look into the smartphone camera for about 30 seconds. environmental and lighning conditions will be kept stable.
The investigators will do the measurements in 200 participants in order to obtaine values in a population characterized by a variety of phenotypes, in the perioperative setting.
- Conditions
- Heart
- Being tested
- Darwin smartphone app, Pulse oxymetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darwin smartphone appDevice
The participant must look into the smartphone camera with the Darwin app for about 30 seconds.
Pulse oxymetryDevice
Heart rate will be measured with pulsoe oximetry (gold standard)
| Study group | Role | What they receive |
|---|---|---|
| Pulse oxymetry | Active comparator | Pulse oxymetry is one of the gold standards for non invasive measurement of heart rate. Receives: Device: Pulse oxymetry |
| Smartphone app | Experimental | This is a new smartphone application which can potentially measure heart rate in less than 30 seconds. Receives: Device: Darwin smartphone app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
accuracy of heart rate measurement
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start1 Jul 2024
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeartStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- All participants will have heart rate measurement 1. by pulse oxymetry 2. by a smartphone application
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital du Valais
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne Hospitals
- Responsible party
- Sponsor
- Investigators
- Patrick Schoettker, MD, Study director, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439511
- Sponsor's protocol ID
- Darwin
- Acronym
- Darwin
- Status last verified
- Nov 2024
- First submitted
- 22 May 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Non Contact Vital Signs Application (Darwin Edge rVSM) on a Smartphone With Traditional Pulse Oximetry for Heart Rate Measurement: a Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT06439511
- Acronym / sponsor ID
- Darwin / Darwin
- Conditions
- Heart
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hôpital du ValaisUniversity, hospital or other
- Collaborators
- University of Lausanne Hospitals
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 3 Jun 2024 (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.
The investigators want to test the accuracy of the Smartphone application Darwin Edge rVSM in measuring heart rate, as compared to traditional pulsoxymetry. The intervention is to look at the smartphone camera for approximately 30 seconds, and after that to compare the heart rate value with that obtained with a recording by pulsoxymetry.
Detailed description
Participants undergoing a routine perianesthetic consultation at the preanesthetic clinic will be recruited. as a part of routine clinical assessment their heart rate is measured with pulsoxymetry, a non invasive device worn at the fingertip for about 1 minute. this measurement will be compared to the values for heart rate that can be obtaine with the ''Darwin Edge rVSM'' mobile application. this application can be installed on any smartphone. the participant is required to look into the smartphone camera for about 30 seconds. environmental and lighning conditions will be kept stable.
The investigators will do the measurements in 200 participants in order to obtaine values in a population characterized by a variety of phenotypes, in the perioperative setting.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants will have heart rate measurement 1. by pulse oxymetry 2. by a smartphone application
| Arm | Type | Receives |
|---|---|---|
| Pulse oxymetry | Active comparator | Device: Pulse oxymetryPulse oxymetry is one of the gold standards for non invasive measurement of heart rate. |
| Smartphone app | Experimental | Device: Darwin smartphone appThis is a new smartphone application which can potentially measure heart rate in less than 30 seconds. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men or women older than 18 years old presenting to the preanesthetic assessment clinic of Valais Hospital
- Subjects that have signed the informed consent form
Key exclusion criteria (2 listed)
- subjects with damaged/injured skin at the face
- Subjects unable to remain still for 30 seconds
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 |
|---|---|---|
| Darwin smartphone appThe participant must look into the smartphone camera with the Darwin app for about 30 seconds. | Device | Smartphone app |
| Pulse oxymetryHeart rate will be measured with pulsoe oximetry (gold standard) | Device | Pulse oxymetry |
Primary outcome
Heart rate
Time frame: 1 minute
accuracy of heart rate measurement
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 22 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Patrick Schoettker, MD study director
University of Lausanne Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Darwin smartphone app and Pulse oxymetry in people with Heart, run by Hôpital du Valais at 1 site in Switzerland.
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 2 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 22 Nov 2024. 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 Switzerland. 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?
Heart rate (time frame: 1 minute). 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 22 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.