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Noninvasive Biosensing Device for Respiratory Diseases

N/A

Waitlist Available

Led By Amir Gandjbakhche, Ph.D.

Research Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of study

Awards & highlights

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.

Who is the study for?

This trial is for healthy adults over 18 with no current flu-like symptoms, coughs, fevers, or sneezing. Participants must be free of skin diseases, cardiovascular or pulmonary issues and not taking certain medications like nitrates that affect blood oxygen levels. Pregnant women and individuals with a history of seizures are excluded.Check my eligibility

What is being tested?

Researchers are testing a new device designed to screen and monitor respiratory diseases by measuring breathing patterns, body temperature, heart rate, and tissue oxygenation during various controlled tasks such as breath-holding and paced-breathing.See study design

What are the potential side effects?

Since this study involves noninvasive monitoring devices similar to Fitbits or pulse oximeters rather than drugs or invasive procedures, significant side effects aren't expected. However, discomfort from wearing the devices may occur.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of study

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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.

Secondary outcome measures

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.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Healthy VolunteerExperimental Treatment6 Interventions

Healthy Volunteer

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fitbit

2021

N/A

~3560

NIRS

2013

N/A

~1080

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Lead Sponsor

1,963 Previous Clinical Trials

2,674,736 Total Patients Enrolled

Amir Gandjbakhche, Ph.D.Principal InvestigatorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

6 Previous Clinical Trials

224 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still available for this particular clinical investigation?

"Affirmative. According to clinicaltrials.gov, this trial was first posted on May 26th 2022 and is still actively seeking participants as of November 10th 2022. The medical research requires 40 patients at one site."

Answered by AI

To what extent is the study recruiting participants?

"Indeed, according to the information on clinicaltrials.gov this research endeavor is currently enrolling participants. It was first placed online on May 26th 2022 and its details were recently updated on November 10th 2022. The trial needs 40 individuals at a single site for participation."

Answered by AI