NCT04204993

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

Influenza ('flu') is one of the most common causes of severe lung infection. Seasonal flu affects between 10 and 46% of the population each year and causes around 12 deaths in every 100,000 people infected. Furthermore, new strains of flu viruses emerge unpredictably every few years, causing pandemics that spread rapidly across the world. Since currently available antiviral drugs and vaccines cannot prevent these outbreaks, it is essential to be able to identify flu infections at an early stage to enable rapid treatment of individuals and implementation of public health measures. 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. To achieve this, the investigators will recruit healthy volunteers and inoculate them with a flu virus, after which they will be observed in hospital while they develop a cold. Each volunteer will be given a number of devices that they will wear before and during infection. In addition, they will have blood and nasal samples taken to examine the way their immune system responds to infection. The resulting data will be analysed to see if the sensors data correlate with the onset of infection and these will be compared with measures of the immune response. Ultimately, the investigators anticipate that optimised sensor data from devices to be developed may be useful in rapidly detecting when someone is about to develop flu infection, so that they can quickly be treated and outbreaks may be identified at an early stage.

Conditions

• Influenza A H3N2

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-02-11
• Primary completion: 2020-12-31
• Completion: 2021-05-17
• First posted: 2019-12-19
• Last updated: 2023-08-21
• Results posted: 2023-08-21

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated device study