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Completed

NCT Number: NCT03300739

Phenotypic Measurements and Their Relation to Disease Exacerbation in COPD Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Partners Connected Health

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Currently on admission in the hospital, on non-invasive positive airway pressure ventilation
  • Visual, hearing or cognitive impairments at the discretion of their physician.
  • Currently participating in a COPD telemonitoring program.
  • No AT&T cellular coverage at their primary residence
  • 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.

Treatment and study plan

Primary outcomes

  1. Respiratory rate (breaths per minute)

    Time frame: Daily, 16 weeks

    Collected by study device, Reassure Respiration Monitor. This device uses very low power radio waves to detect respiratory movements of a person while asleep.

Secondary outcomes

  1. Oxygen saturation (%)

    Time frame: Daily for 16 weeks

    Collected via pulse oximeter.

  2. Forced Expiratory Volume in 1 Second (FEV1). FEV1 is the volume of air forcefully exhaled in 1 second.

    Time frame: Weekly for16 weeks

    Collected via spirometer

  3. Physical activity

    Time frame: Daily for 16 weeks

    Collected via step counts

  4. Body Mass Index (kg/m^2)

    Time frame: Baseline (Day 0) and Close-out (16 weeks)

    Weight and height will be combined to report BMI

  5. Quality of life

    Time frame: Baseline (Day 0) and Close-out (16 weeks)

    Collected via SF-12 questionnaire

  6. Depression

    Time frame: Monthly for 16 weeks

    Collected via PHQ-8 questionnaire

  7. Anxiety

    Time frame: Baseline (Day 0) and Close-out (16 weeks)

    Collected via GAD-7 questionnaire

  8. COPD symptom assessment

    Time frame: Weekly for 16 weeks

    Collected via CAT questionnaire

  9. Functional impairment due to dyspnea

    Time frame: Weekly for 16 weeks

    Collected via mMRC dyspnea scale

  10. Study device usability

    Time frame: Close-out (16 week)

    Collected via usability questionnaire

  11. Medical treatment

    Time frame: Baseline (Day 0) and Close-out (16 weeks)

    Collected via electronic health record

  12. Hospitalization records

    Time frame: Baseline (Day 0) and Close-out (16 weeks)

    Collected via electronic health record

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • ResMed

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 3, 2017
Registry last updated
Sep 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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