Respiratory Virus clinical trials

Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies

Background: Respiratory viruses circulate throughout the year and around the globe. Wearable and sensor devices, like smartwatches, may be able to help monitor infectious diseases. Researchers want to use them to learn how respiratory viruses affect people in different ways. Objective: To use digital devices to collect data from participants in challenge studies that could indicate subtle changes in health during an infection that might otherwise go unnoticed. Eligibility: Healthy adults who have enrolled in a challenge study. Design: Participants will stay at NIH for at least 9 days and then they will have outpatient visits. While at NIH, participants will wear a smartwatch at all times. It will record data like temperature, heart rate, breathing rate, and movements. Participants will have 2 smartphones. One will be recording at all times to listen for coughing. Participants will use the other smartphone to check their vital signs. They will collect data like heart rate, temperature, and the level of oxygen in the blood every 4 hours during the daytime. Participants will perform tasks every 4 hours during the daytime. They will record themselves coughing, breathing in deeply, and reading aloud. They will take pictures and videos of their face. A bedside sensor will record participants while they sleep. It will record heart rate and breathing rate. It will also look at sleep activity, such as movements participants make during sleep and how deeply they sleep. Participants sharing the same room will be exposed to the same challenge virus. For outpatient visits, participants will use one smartphone and the smartwatch to complete the above tasks. Participation will last from 10 weeks to 1 year.