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Mobile Biosensor for Measuring Vital Signs in Healthcare and Home Settings

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04233827
Recruitment Status : Active, not recruiting
First Posted : January 18, 2020
Last Update Posted : March 4, 2021
Sponsor:
Information provided by (Responsible Party):
Sara H. Browne, MD, MPH, University of California, San Diego

Study Description
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Brief Summary:
This study will record vital signs (heart rate and blood oxygen levels) using a new cell phone integrated biosensor and compare it to routine measurements carried out in the clinics and hospital at UCSD. Cell phones will be given to a selected group of subjects for use at home and data collected.

Condition or disease
Pulse Oximetry

Detailed Description:

Maxim Vital Sign study is a 2 part, investigator initiated observational study with Maxim Integrated aimed to compare vital sign readings using 2 prototype versions of new cell phone based mobile biosensors with standard of care (SOC). Adult subjects will be recruited from UCSD outpatient clinics, AVRC clinic, emergency department (ED), and hospitals. Vital signs will be measured using cell phone based mobile biosensors and SOC.

For Phase 1, up to 800 subjects will be recruited (700 adults and up to 100 adolescents). 250 subjects (200 adults and up to 50 adolescents) will participate in phase 1a and 550 subjects (500 adults and up to 50 adolescents) will participate in phase 1b. An additional group of 30 adult subjects will be recruited from outpatient clinics for participation in phase 2.

Phase 1a:

Two identical copies of the device will be tested during the first part of phase 1 with a total of 125 subjects (100 adults and up to 25 adolescents). Each prototype version will be tested on up to 125 subjects (100 adults and 25 adolescents) and compared to readings obtained by Welch-Allyn Spot Vital Signs monitor. Data will be obtained on the usability and accuracy of the measurements with each initial prototype. Measurement particularly of SpO2 depends on accurate finger position. Current SpO2 monitors encase the finger and immobilize it in order to obtain an accurate measurement. Maxim Integrated, in collaboration with DD Studios, Carlsbad CA, and Specialists in Global Health, Encinitas CA, have developed prototypes, which will be tested to inform design flaws in future prototypes.

Phase 1b:

Based on the results from phase 1a, one of the prototypes will be selected for further testing (the one with the least within-instrument variation). During Phase 1b, vital sign readings will be collected with the selected Maxim biosensor prototype and one of the Welch-Allyn Spot Vital Signs monitor simultaneously. The subjects will be recruited from both outpatient and hospital settings for accuracy and usability. A total of 550 subjects (500 adults and 50 adolescents) will be recruited for this part of phase 1.

Study Design
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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mobile Biosensor for Measuring Vital Signs in Healthcare and Home Settings
Actual Study Start Date : October 20, 2016
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vital Signs

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Accuracy of vital signs (HR and SpO2) [ Time Frame: 20 minutes ]
    The accuracy of the vital sign (HR and SpO2) readings collected by Maxim biosensor compared to standard of care Welch-Allyn Spot Vital Sign monitor.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Children (≥ 13 years old) and adult male and female subjects who provide written informed consent and assent.
Criteria

Inclusion Criteria:

  1. Children (≥ 13 years old) and adult male and female subjects who provide written informed consent and assent.
  2. Subjects must be willing to use the mobile device and answer questions regarding their experience.

Exclusion Criteria:

Individuals with prior or recent injury to one or both of their index fingers that would prevent or interfere with the use of Maxim biosensor.

Contacts and Locations
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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): NCT04233827


Locations
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United States, California
UCSD AntiViral Research Center
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Sara H Browne, MD MPH UC San Diego
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sara H. Browne, MD, MPH, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04233827    
Other Study ID Numbers: 161573
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 2021

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