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Vital Sign Comparison Between Lifelight and Standard of Care - Development (VISION-D)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04003662
Recruitment Status : Recruiting
First Posted : July 1, 2019
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
Xim Limited

Brief Summary:
Patients and volunteers both with and without medical problems will be recruited; vital sign measurements are taken twice with normal equipment and while recording video data at the same time. The data collected will allow the Artificial Intelligence to develop the LifeLight algorithm to to improve measurement accuracy of its video data based vital signs monitor.

Condition or disease Intervention/treatment
Vital Signs Device: Vital Signs Measurement

Detailed Description:

Vital signs such as heart rate, blood pressure, breathing rate and oxygen levels currently need several pieces of equipment and trained staff in order to be measured properly. The LifeLight app measures the same vital signs using a camera in a phone, tablet, laptop or smart TV. By using very small changes in the colour of your skin, LifeLight's AI system can calculate these values without any extra equipment or training, and without contact.

The aim of this research study is to improve the accuracy of the LifeLight system with a view to a subsequent Validation study to prove the level of accuracy. The investigators will recruit patients, staff and visitors, both with and without medical problems, and take vital sign measurements twice with normal equipment and while recording video data at the same time. This will allow the AI which develops the LifeLight algorithm to make it more accurate, prior to a subsequent study which will validate the results.

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Study Type : Observational
Estimated Enrollment : 9000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vital Sign Comparison Between Lifelight and Standard of Care - Development
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vital Signs

Group/Cohort Intervention/treatment
inpatients
Vital signs measurement - standard of care and prototype
Device: Vital Signs Measurement
Vital signs are measured twice with standard of care equipment while recording digital video data at the same time.

outpatients
Vital signs measurement - standard of care and prototype
Device: Vital Signs Measurement
Vital signs are measured twice with standard of care equipment while recording digital video data at the same time.

Healthy controls
Vital signs measurement - standard of care and prototype
Device: Vital Signs Measurement
Vital signs are measured twice with standard of care equipment while recording digital video data at the same time.




Primary Outcome Measures :
  1. Blood Pressure Readings [ Time Frame: Single Visit; up to one day ]
    Comparison of digital video data to standard of care measurement

  2. Oxygen Saturation Readings [ Time Frame: Single Visit; up to one day ]
    Comparison of digital video data to standard of care measurement

  3. Heart Rate (pulse) Readings [ Time Frame: Single Visit; up to one day ]
    Comparison of digital video data to standard of care measurement

  4. Respiratory Rate [ Time Frame: Single Visit; up to one day ]
    Comparison of digital video data to standard of care measurement



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The inclusion/exclusion criteria is limited to the proposed intended use of the device, therefore only individuals, of any sex, over the age of 3 will be included in the study.
Criteria

Inclusion Criteria:

  • I1. Sufficiently conversant in the English language to satisfy I3.
  • I2. Able and willing to comply with all study requirements.
  • I3. Able and willing to provide written informed consent to participate (including by parent or legal guardian if under 16 years old).

Exclusion Criteria:

  • There are no exclusion criteria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04003662


Contacts
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Contact: Emily Heiden 02392 286000 ext 4108 Emily.Heiden@porthosp.nhs.uk

Locations
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United Kingdom
Portsmouth Hospitals NHS Trust Recruiting
Portsmouth, England, United Kingdom, PO6 3LY
Contact: Elaine Baddeley    02392 286000 ext 5153    elaine.baddeley@porthosp.nhs.uk   
Sponsors and Collaborators
Xim Limited
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Responsible Party: Xim Limited
ClinicalTrials.gov Identifier: NCT04003662    
Other Study ID Numbers: PHT/2018/25 IRAS ID 242581
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No