Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2026-01-01 @ 11:37 PM
Study NCT ID:
NCT04204993
Status:
COMPLETED
Last Update Posted:
2023-08-21
First Post:
2019-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessment of Wearable Sensors During Experimental Human Influenza Infection (Sigma Plus)
Sponsor:
Imperial College London
Organization:
Study Overview
Official Title:
Assessment of Wearable Sensors During Experimental Human Influenza Infection (Sigma Plus)
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: