Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies

Influenza Clinical Trial

Official title:

Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04772170
• Other study ID #: 10000291
• Secondary ID: 000291-I
• Status: Recruiting
• Start date: October 23, 2023
• Est. completion date: June 2, 2025

Study information

• Verified date: June 17, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Rani S Athota, Ph.D.
• Phone: (301) 594-0803
• Email: kotar[@]mail.nih.gov
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2, 2025
• Est. primary completion date: June 2, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

• 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 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 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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To correlate continuous cough sensor data to cough severity after challenge.	Cough is a known symptom of respiratory virus infections and can be quantified by objective measurements.	minimum of 9 days inpatient
Secondary	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.	minimum of 9 days inpatient

External Links

•   NIH Clinical Center Detailed Web Page