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Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies

National Institute of Allergy and Infectious Diseases (NIAID) · NCT04772170

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–65 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
1000
US sites recruiting
1
Study start
October 23, 2023
Record last updated
September 9, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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: Influenza; Respiratory Virus; Coronavirus

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria
  • INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  • Able to provide informed consent.
  • Current, recent, or planned enrollment in a respiratory virus challenge study at the NIH Clinical Center.
  • Willing to wear 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 such as vital signs, viral shedding, pulmonary function test and/or spirometry results, and clinical symptoms data shared with investigators at University of Washington and University of Toronto.

EXCLUSION CRITERIA

An individual who meets any of the following criteria will be excluded from participation in this study:

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

Co-enrollment guidelines: Participants must be co-enrolled, planned for co-enrollment, or recently enrolled in a challenge study. Co-enrollment in other studies is restricted but may take place after study staff notification and only with approval of the principal investigator or designee.

Recruiting US locations

  • National Institutes of Health Clinical Center

    Bethesda, MD 20892

    Site contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · 800-411-1222 · prpl@cc.nih.gov

Study contacts (from the official record)

  • Rani S Athota, Ph.D. · (301) 594-0803 · rani.athota@nih.gov
  • Luca T Giurgea, M.D. · (301) 538-5235 · luca.giurgea@nih.gov
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Observational Digital Biomarker Discovery in Respiratory Virus… (NCT04772170) | Bored Studies