Phenotypic Measurements and Their Relation to Disease Exacerbation in COPD Patients

NCT ID: NCT03300739

Last Updated: 2020-09-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2019-09-30

Brief Summary

This is an observational pilot study focused on collecting data on clinical variables that can improve the understanding of potential predictors of disease exacerbation and readmissions in COPD patients. The study aim is to understand how the variability of clinical parameters (respiratory rate, forced expiratory volume in one second, and oxygen saturation), physical activity and quality of life is associated with the risk of exacerbation in COPD patients.

Detailed Description

The investigational product to be used in this trial is the ResMed Biomotion Sensor (ResMed Sensor Technologies, Dublin, Ireland). This device uses very low power radio waves (~1/100th of the strength of a mobile phone signal) to detect respiratory movements of a person while asleep- without physical contact with the individual. The device is designed to measure up to 5 feet, so that only the person on the side of the bed nearest the device is monitored. Algorithms have been developed to analyze the respiratory movement signals and extract information about respiration rate, bodily movements, sleep/wake patterns and sleep disordered respiration.

Conditions

COPD Exacerbation; Copd

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Medically stable and ambulatory COPD (primary diagnosis) patients who have had an emergency room visit or hospitalization for an acute exacerbation of COPD within the past 30 days.

2. Sufficient understanding of the English language to be able to read and understand study procedures.

Exclusion Criteria

1. Currently on admission in the hospital, on non-invasive positive airway pressure ventilation

2. Visual, hearing or cognitive impairments at the discretion of their physician.

3. Currently participating in a COPD telemonitoring program.

4. No AT&T cellular coverage at their primary residence

5. Any other medical or psychological condition that, in the opinion of the investigator may present an unreasonable risk to the study participant as a result of his/her participation in this study, may make participant's participation unreliable, or may interfere with study assessments.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ResMed

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Joseph C. Kvedar

Dermatologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen Agboola, MD

Role: PRINCIPAL_INVESTIGATOR

MGH

Locations

Partners Connected Health

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2016P002312

Identifier Type: -

Identifier Source: org_study_id