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Assessment of Wearable Sensors During Experimental Human Influenza Infection (Sigma Plus)

NCT04204993 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-08-21

Study results available
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Summary

The aim of the study is to investigate disease in volunteers deliberately infected with influenza A(H3N2), including biological markers of inflammation and immune response, and changes in physiological parameters including heart rate, respiratory rate, physical activity, oxygen saturation and electrocardiographic data during the onset of influenza infection. Ultimately, this may lead to prediction of symptomatic disease at an earlier stage to allow more effective interventions. The experimental medicine study design will involve human influenza infection challenge, whereby volunteers will be inoculated with influenza virus and monitored in hospital for 10 days as they develop and get better from flu. Continuously-monitoring wearable physiological sensors will be given to the participants 7 days before this and worn continuously until the end of the flu infection.

Conditions

  • Influenza A H3N2

Interventions

DEVICE

Lumee Oxygen Platform

Two sensors will be inserted (one in the skin fo the upper arm and one on the side of the chest). A wireless patch reader is placed on top of the skin over the area where the sensor has been placed to measure local oxygen content.

Sponsors & Collaborators

  • Duke University

    collaborator OTHER

  • RTI International

    collaborator OTHER

  • Defense Advanced Research Projects Agency

    collaborator FED

  • Imperial College London

    lead OTHER

Principal Investigators

  • Christopher Chiu · Imperial College London

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-11
Primary Completion
2020-12-31
Completion
2021-05-17
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04204993 on ClinicalTrials.gov