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Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies

NCT04772170 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2025-10-09

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Luca T Giurgea, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-23
Primary Completion
2026-06-02
Completion
2026-06-02

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04772170 on ClinicalTrials.gov