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CompletedNCT06439511DarwinUpdated Nov 22, 2024

Comparison of a Non Contact Vital Signs Application With Traditional Pulse Oximetry for Heart Rate Measurement

An interventional study of Darwin smartphone app and Pulse oxymetry in Heart, sponsored by Hôpital du Valais. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-22.

Sponsored by Hôpital du Valais · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Heart
03

In context

Lead sponsor

Hôpital du Valais is the lead sponsor of 15 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Men or women older than 18 years old presenting to the preanesthetic assessment clinic of Valais Hospital
  • Subjects that have signed the form

Exclusion criteria

Exclusion criteria:

  • subjects with damaged/injured skin at the face
  • Subjects unable to remain still for 30 seconds
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Active comparator
    Pulse oxymetry

    Pulse oxymetry is one of the gold standards for non invasive measurement of heart rate.

    Device: Pulse oxymetry

  • Experimental
    Smartphone app

    This is a new smartphone application which can potentially measure heart rate in less than 30 seconds.

    Device: Darwin smartphone app

Interventions

  • DeviceDarwin smartphone app

    The participant must look into the smartphone camera with the Darwin app for about 30 seconds.

  • DevicePulse oxymetry

    Heart rate will be measured with pulsoe oximetry (gold standard)

06

What researchers measure

Primary outcomes

  1. Heart rate

    accuracy of heart rate measurement

    Time frame: 1 minute

07

Study locations

1 site
  • Valais Hospital
    Sion, Valais 1950, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2024 to primary completion in Oct 2024, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 22, 2024
First posted
Jun 3, 2024
StartActual
Jul 1, 2024
Primary completionActual
Oct 31, 2024
CompletionActual
Oct 31, 2024
Last update
Nov 22, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06439511
Lead sponsor
Hôpital du Valais
Responsible party
Sponsor
First posted
Jun 3, 2024
Start date
Jul 1, 2024
Primary completion
Oct 31, 2024
Completion
Oct 31, 2024
Last update
Nov 22, 2024

Study contacts

Patrick Schoettker, MD
study director · University of Lausanne Hospitals

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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