Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies

Influenza Clinical Trial

Official title: Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 collect data on coughing, speech, heart rate, heart rhythm, sweating, temperature, activity, and fatigue to identify digital biomarkers associated with respiratory virus infection. The correlation between digital device measurement data and clinical data, particularly on cough, will be determined. We hypothesize that sensor-collected data will correlate with symptom severity obtained by clinician assessment and participant report. We also hypothesize that digital biomarkers can predict influenza infection and can be used to develop a predictive model.

Objectives:

Primary:

1. To correlate continuous cough sensor data to cough severity after challenge.

2. To develop a predictive model for mild-moderate influenza disease (MMID) and influenza infection using digital biomarkers

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:

1. Cough quantity:

-Continuous cough measurements

2. Infection

• Defined as:

• MMID (positive PCR for influenza and >=1 symptoms)

• Flu (positive PCR for influenza or convalescent four-fold increase in serum antibodies to the hemagglutinin (HA) or neuraminidase (NA) of the challenge virus and >=1 symptoms)

• Influenza infection (positive PCR for influenza)

• Using Predictor variables:

• Smartwatch photoplethysmography (PPG) determined heart rate

• Smartwatch electrodermal activity (EDA) determined sweating

• Smartwatch determined temperature

• Smartwatch activity tracking

• Smartwatch Electrocardiogram (ECG) monitoring

• Facial video recording (including PPG)

• Audio voice recording

• Smartphone psychomotor vigilance testing (PVT)

Secondary: Vital signs:

3. Heart rate

4. Respiratory rate

5. Temperature

Exploratory: Facial and body sensor data via quantitative measures of:

6. Facial imaging

7. Voice recording

8. Activity/Sleep monitoring

9. Blood pressure (measured through facial imaging)

Study Population:

N=20-80 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. ;

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections
• Influenza
• Respiratory Virus
• Virus Diseases

• NCT number: NCT04772170
• Study type: Observational
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Rani S Athota, Ph.D.
• Phone: (301) 594-0803
• Email: kotar@mail.nih.gov
• Status: Recruiting
• Start date: October 23, 2023
• Completion date: June 2, 2025