Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
Healthy volunteers currently enrolled in a respiratory virus challenge study
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 1 trial groupGroup A: Current Challenge Study Participant
Trial outcomes
Primary outcomes
1
To correlate continuous cough sensor data to cough severity after challenge.To develop a predictive model for MMID and asymptomatic influenza infection using digital biomarkers.
Cough is a known symptom of respiratory virus infections and can be quantified by objective measurements.Data from smart devices may be able to discern who gets sick with a respiratory virus and could be utilized as a diagnostic tool.
Time frame
minimum of 9 days inpatientSecondary outcomes
1
To correlate continuous and noncontinuous vital signs sensor data to routine vital signs obtained by clinical staff.
Vital signs are routinely measured in challenge studies and are also routinely collected from digital devices. Vital sign changes can be associated with respiratory virus infections.
Time frame
minimum of 9 days inpatientSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov