Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies
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
| Condition(s) | Influenza, Respiratory Virus, Coronavirus |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. I |
| Who can participate | * INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Able to provide informed consent. 2. Current, recent, or planned enrollment in a respiratory virus challenge study at the NIH Clinical Center. 3. Willing to wear devices as instructed. 4. Willing to participate in monitoring activities as instructed. 5. Willing to have monitoring data stored. 6. Willing to have monitoring data shared with protocol investigators at NIH, University of Washington, and University of Toronto. 7. 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 Uni |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Locations | Bethesda, Maryland, United States |
| Start date | 2023-10-23 |
| NCT ID | NCT04772170 |
| Official listing | https://clinicaltrials.gov/study/NCT04772170 |