Actively Recruiting

Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT04772170

Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2025-10-09

1000

Participants Needed

1

Research Sites

136 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to provide informed consent.
  • Currently enrolled, recently enrolled, or planning to enroll in a respiratory virus challenge study at the NIH Clinical Center.
  • Willing to wear monitoring devices as instructed.
  • Willing to participate in monitoring activities as instructed.
  • Willing to have monitoring data stored.
  • Willing to have monitoring data shared with protocol investigators at NIH, University of Washington, and University of Toronto.
  • Willing to have select clinical data from the challenge study shared with investigators at University of Washington and University of Toronto.
Not Eligible

You will not qualify if you...

  • Any condition that, in the opinion of the investigator, contraindicates participation in this study.

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

R

Rani S Athota, Ph.D.

CONTACT

L

Luca T Giurgea, M.D.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies | DecenTrialz