Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies
National Institute of Allergy and Infectious Diseases (NIAID)
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.
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 before and after respiratory virus challenge on a separate NIH protocol. Participants recently enrolled, currently enrolled, or planned for enrollment in a challenge study are eligible. All devices will be worn and/or used during the inpatient hospitalization and at outpatient follow-up visits. Participants may be sent smartwatches at home to collect additional baseline or healthy data. Devices wi…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
* 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…
Location
- National Institutes of Health Clinical CenterBethesda, Maryland