Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Feb 25, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how respiratory viruses, like the flu and coronaviruses, affect people's health using digital devices like smartwatches and smartphones. Researchers want to gather data that shows small changes in health during an infection that might not be noticed otherwise. The goal is to better understand how these viruses behave and impact individuals.

To participate, you need to be a healthy adult currently enrolled in another study that intentionally exposes you to respiratory viruses at the NIH Clinical Center. If you join, you'll wear a smartwatch and use two smartphones to track your heart rate, temperature, and breathing, along with recording any coughing. You'll stay at NIH for at least 9 days and complete various tasks throughout the day. Your participation can last anywhere from 10 weeks to a year. It's important to know that the data collected will help researchers at NIH and other universities learn more about respiratory viruses and their effects on health.

Gender

ALL

Eligibility criteria

• * 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 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.