Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Not yet recruiting

CT.gov ID

NCT04772170

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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 in a challenge study.

Design:

Participants will stay at NIH for at least 9 days and then they will have outpatient visits.

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 2 smartphones. One will be recording at all times to listen for coughing. Participants will use the other smartphone to check their vital signs. They will collect data like heart rate, temperature, and the level of oxygen in the blood every 4 hours during the daytime.

Participants will perform tasks every 4 hours during the daytime. They will record themselves coughing, breathing in deeply, and reading aloud. They will take pictures and videos of their face.

A bedside sensor will record participants while they sleep. It will record heart rate and breathing rate. It will also look at sleep activity, such as movements participants make during sleep and how deeply they sleep.

Participants sharing the same room will be exposed to the same challenge virus.

For outpatient visits, participants will use one smartphone and the smartwatch to complete the above tasks.

Participation will last from 10 weeks to 1 year.

Condition or Disease	Intervention/Treatment	Phase
Influenza Respiratory Virus Coronavirus

Detailed 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 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:

Forced nasal inspiration

2 Forced cough

Facial imaging
Sleep monitoring
Activity monitoring
Reading aloud
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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies

Anticipated Study Start Date :

Aug 30, 2022

Anticipated Primary Completion Date :

Nov 29, 2024

Anticipated Study Completion Date :

Nov 29, 2024

Arms and Interventions

Arm	Intervention/Treatment
Current Challenge Study Participant Current participation in a respiratory virus challenge study at the NIH CC

Outcome Measures

Primary Outcome Measures

To correlate continuous cough sensor data to cough severity after challenge. [minimum of 9 days inpatient]
Cough is a known symptom of respiratory virus infections and can be quantified by objective measurements.

Secondary Outcome Measures

To correlate continuous and noncontinuous vital signs sensor data to routine vital signs obtained by clinical staff. [minimum of 9 days inpatient]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

Able to provide informed consent.
Current 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.
Willing to have monitoring data stored.
Willing to have monitoring data shared with protocol investigators at NIH, University of Washington, and University of Toronto.
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:

Any condition that, in the opinion of the investigator, contraindicates participation in this study.

Co-enrollment guidelines: Participants must be co-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.