Fitbit for Coronavirus

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Coronavirus+6 MoreFitbit - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a device that could help screen, detect, and monitor symptoms linked to respiratory diseases like COVID-19. The device measures breathing, body temperature, heart rate, and tissue oxygenation.

Eligible Conditions
  • Coronavirus
  • Common Cold
  • Bronchitis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: End of study

End of study
Characterize arterial oxygen saturation (SpO2), peripheral oxygen saturation (StO2) and cerebral oxygen saturation (ScO2) during respiratory perturbations.
Compare measured changes in cardiac, respiratory, and tissue oxygenation parameters during induced hypercapnia, breath holding, and paced breathing exercises between the biosensor and commercial systems.
Compare performance of a multimodal biosensor device with commercial systems for measuring vital physiological signals including cardiac, respiratory, and tissue oxygenation in individuals at rest.

Trial Safety

Trial Design

1 Treatment Group

Healthy Volunteer
1 of 1

Experimental Treatment

40 Total Participants · 1 Treatment Group

Primary Treatment: Fitbit · No Placebo Group · N/A

Healthy VolunteerExperimental Group · 6 Interventions: Periflux 6000 EPOS, Douglas Bag, Fitbit, BIOPAC, Flowmet, NIRS · Intervention Types: Device, Device, Device, Device, Device, Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fitbit
2018
N/A
~3440
NIRS
2013
N/A
~1080

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: end of study

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Lead Sponsor
1,824 Previous Clinical Trials
2,249,383 Total Patients Enrolled
Amir Gandjbakhche, Ph.D.Principal InvestigatorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6 Previous Clinical Trials
482 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The body temperature was within the normal range on the day of the experiment.
The study participant must provide a signed and dated informed consent form in order to participate in the study.
I am willing to comply with all study procedures and be available for the duration of the study.
People aged 18 years or older, whether they are male or female.
The person is generally in good health and does not have any signs of a cough, sneeze, or upper respiratory symptoms.

Who else is applying?

What state do they live in?
District of Columbia40.0%
Florida40.0%
Texas20.0%
How old are they?
65+50.0%
18 - 6550.0%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%
What site did they apply to?
National Institutes of Health Clinical Center100.0%