Mobile Biosensor for Measuring Vital Signs in Healthcare and Home Settings

Pulse Oximetry Clinical Trial

Official title:

Mobile Biosensor for Measuring Vital Signs in Healthcare and Home Settings

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04233827
• Other study ID #: 161573
• Status: Recruiting
• Start date: October 20, 2016
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2022
• Source: University of California, San Diego
• Contact: Sara H Browne, MD MPH
• Phone: 619 543 8080
• Email: shbrowne[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pulse Oximetry

Locations

Country	Name	City	State
United States	UCSD AntiViral Research Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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