Respiratory Infection Monitoring

NCT04362631 | Completed

• 1 other identifier: STU00210701
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This study will monitor physical bio-markers such as heart rate, respiratory rate, and temperature to detect potential respiratory infections.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (2)

• Efficacy of wearable device to detect respiratory infection parameters: cough count

  Device data measuring cough count. Captured by analysis of peak acclerometer graphing and duration in meters per second squared (m/s2).

  1 year

• Monitoring of respiratory infection symptoms, WURSS-11 Survey

  WURSS-11 survey. https://www.fammed.wisc.edu/files/webfm-uploads/documents/research/wurss-11.pdf The WURSS-11 survey will be conducted on a weekly basis by study subjects for the duration of the study (up to 52 weeks).

  1 year

Study Arms (1)

Adults

Adults 18 years or older

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults

You may qualify if:

• ≥18 years old
• Outpatient at start of the study
• Established clinical history of COPD
• Previous hospital or ICU admission for pneumonia or COPD
• Active corticosteroid prescription
• Willingness to participate in the study (long term continuous wear of the device)
• Ability to apply and remove devices and use a mobile application

You may not qualify if:

• Mental or neurodegenerative disease
• Including a current diagnosis of asthma, respiratory disorders (e.g. active tuberculosis, lung cancer, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases); pneumonia or other RTIs not resolved ≤14 days or ≤7 days, respectively, prior to screening
• Skin condition or wound on suprasternal notch.

Sponsors & Collaborators

• Northwestern University: lead
• Department of Health and Human Services: collaborator

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shuai Xu

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 27, 2020
• Study Start: April 24, 2020
• Primary Completion: September 6, 2022
• Study Completion: September 6, 2022
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)