Status:
RECRUITING
Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Respiratory Virus
Eligibility:
All Genders
18-65 years
Brief 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 t...
Detailed Description
Study Description: Wearable and sensor digital devices have the potential to be important tools in infectious diseases surveillance. In this study, digital devices will be used to evaluate responses ...
Eligibility Criteria
Inclusion
- 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:
- 1\. 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.
Exclusion
Key Trial Info
Start Date :
October 23 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 2 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04772170
Start Date
October 23 2023
End Date
June 2 2026
Last Update
October 9 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892