Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Coronavirus
- Influenza
- Respiratory Virus
- Type
- Observational
- Design
- Observational Model: Case-OnlyTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
Title: Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies 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 af...
Title: Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies 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 already enrolled 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 will not be discharged home with any devices. These devices will be used to identify biomarkers associated with respiratory virus infection. We hypothesize that sensor collected data will correlate with symptom severity obtained by clinician assessment and participant report. Objectives: Primary: To correlate continuous cough sensor data to cough severity after challenge. Secondary: To correlate continuous and noncontinuous vital sign sensor data to routine vital signs obtained by clinical staff. Exploratory: To evaluate facial and body sensor data after challenge. Endpoints: Primary: Cough quantity: 1.Continuous cough measurements Secondary: Vital signs: Heart rate Respiratory rate Temperature Pulse oximetry Exploratory: Facial and body sensor data via quantitative measures of: 1. Forced nasal inspiration 2 Forced cough 3. Facial imaging 4. Sleep monitoring 5. Activity monitoring 6. Reading aloud 7. Blood pressure Study Population: N=50 adult healthy volunteers enrolled in LID CSU respiratory virus challenge studies. Description of Sites/Facilities Enrolling Participants: Participants will be enrolled at the NIH Clinical Center (CC). This study will take place at the NIH CC in the Special Clinical Studies Unit or other appropriate designated clinical area for the inpatient hospitalization and in the OP8 clinic or other appropriate designated clinical area for outpatient visits. Study Duration: Approximately 3 years from start of enrollment to completion of data analyses. Participant Duration: Approximately 10 weeks through 1 year depending on the challenge study. This includes a minimum 9-day inpatient hospitalization for respiratory virus challenge through the follow-up visit 8 weeks to 1 year after discharge.
Tracking Information
- NCT #
- NCT04772170
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Alison Han, M.D. National Institute of Allergy and Infectious Diseases (NIAID)