RecruitingNCT04772170

Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies


Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

1,000 participants

Start Date

Oct 23, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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, were recently enrolled, or are scheduled to enroll in a challenge study. Design: Participants will stay at NIH for the duration of the challenge study (at least 9 days) and then will have outpatient follow-up visits (2-4). 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 a smartphone that records at all times to listen for coughing and changes in voice. Participants will perform tasks every 4 hours during the daytime. They will record themselves coughing, breathing in deeply, and reading aloud. They will take videos of their face. They will play a game to test their reflexes and focus. They will measure their head temperature with their smartwatch. For outpatient visits, participants will use one smartphone and the smartwatch to complete the above tasks. Participants will be sent a smartwatch to wear at home at night to collect additional healthy data. Participation will last the duration of each challenge study, and may range from 10 weeks to 2 years.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This observational study is collecting wearable device and biometric data from healthy volunteers who are participating in controlled human respiratory virus challenge studies at the NIH Clinical Center. In a virus challenge study, participants are intentionally exposed to a controlled dose of a respiratory virus (like influenza or a cold virus) under careful medical supervision, and researchers observe how the body responds. This companion study layers on digital monitoring — using wearable devices such as smartwatches or biosensors — to discover new digital biomarkers that might predict illness before symptoms appear. The goal is to determine whether changes in heart rate, activity, breathing patterns, or other signals detected by wearable devices can serve as early warning signs of respiratory infection. This could eventually improve how we detect and monitor illness in large populations. You may be eligible if... - You are between 18 and 65 years old - You are currently enrolled in, recently enrolled in, or planning to enroll in a respiratory virus challenge study at the NIH Clinical Center - You are willing to wear monitoring devices, participate in monitoring activities, and allow data to be shared with study investigators You may NOT be eligible if... - You have any condition that, in the investigator's opinion, makes participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT04772170


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