NCT04233827

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
361

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2016

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

June 19, 2025

Status Verified

December 1, 2022

Enrollment Period

6.2 years

First QC Date

January 14, 2020

Last Update Submit

June 16, 2025

Conditions

Pulse Oximetry

Outcome Measures

Primary Outcomes (1)

  • Accuracy of vital signs (HR and SpO2)

    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.

    20 minutes

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Children (≥ 13 years old) and adult male and female subjects who provide written informed consent and assent.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD AntiViral Research Center

San Diego, California, 92103, United States

Location

Related Publications (1)

  • Browne SH, Bernstein M, Pan SC, Gonzalez Garcia J, Easson CA, Huang CC, Vaida F. Smartphone Biosensor With App Meets FDA/ISO Standards for Clinical Pulse Oximetry and Can Be Reliably Used by a Wide Range of Patients. Chest. 2021 Feb;159(2):724-732. doi: 10.1016/j.chest.2020.08.2104. Epub 2020 Sep 11.

    PMID: 32926871DERIVED

Study Officials

  • Sara H Browne, MD MPH

    UC San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 14, 2020

First Posted

January 18, 2020

Study Start

October 20, 2016

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

June 19, 2025

Record last verified: 2022-12

Locations

US(1)