Respiration Rate Monitoring in COPD Patients
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reassure Non-Contact Respiration Monitor
Sponsored by
About this trial
This is an interventional prevention trial for Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
Inclusion Criteria:
- Males or females age ≥35 years old
- Documented diagnosis of moderate to very severe COPD (GOLD Level II-IV)
- Weight ≥35 kg
- Currently using the COPD Co-PILOT application (at least 3 months with 70% compliance)
- Must be able to read and understand English and consent for themselves
Exclusion Criteria:
- Currently using any form of non-invasive positive airway pressure ventilation
- Diagnosis of significant heart failure (NYHA Class III or IV)
- Cognitive impairment (determined by physician) that will make it hard to follow instructions regarding device usage
- BMI ≥45.5
- Residing in hospice care, Skilled Nursing Facilities or Long Term Acute Care facilities
- Currently using a wearable drug infusion pump to deliver medication
- Planned procedures at time of enrollment that will occur within timeframe of study and require hospitalization etc.
- Declines to participate at any time.
- In the opinion of the Investigator, may be non-compliant with study schedules or procedures
- No cellular coverage at their primary residence
Sites / Locations
- HGE Health Care Solutions
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Respiration rate monitoring
Arm Description
Reassure Non-Contact Respiration Monitor
Outcomes
Primary Outcome Measures
Correlation of Respiration Rate to Indicators of Healthcare Utilization
Indicators of healthcare utilization include change in medications for COPD, number of office or ER visits, number of hospitalizations.
Secondary Outcome Measures
Sensitivity and Specificity of Respiration Rate to Predict COPD Worsening
Sensitivity and Specificity of Respiration Rate in Conjunction with COPD Co-PILOT Scores to Predict COPD Worsening
Correlation of Respiration Rate to COPD Episode Duration
Episode duration is defined by number of days from COPD Co-PILOT Score >1 to resolution (COPD Co-PILOT Score <1 for 7 consecutive days)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03030313
Brief Title
Respiration Rate Monitoring in COPD Patients
Official Title
Assessment of the Temporal Changes in Nightly Respiration Rate in Combination With a Daily Symptom Reporting Application for Facilitating Early Treatment of Symptoms in COPD Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
July 26, 2017 (Actual)
Study Completion Date
July 26, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ResMed
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Assess the feasibility of using remote respiration rate monitoring as a component of home care, how respiration rate data may be used in combination with other data to potentially improve response to symptoms, and to generate data to inform the endpoints and effect sizes of future studies.
Detailed Description
The research question is whether monitoring of respiration rates and variability can be helpful in management of COPD patients in conjunction with or separately from self-reported symptom scores using the COPD Co-PILOT application. Current techniques (such as patient's self-reported symptoms) have limited sensitivity and specificity with regard to predicting decompensation. Measurement of respiration parameters and the variability of the parameters may detect worsening COPD. Changes in respiration patterns may occur sufficiently far in advance of decompensation (e.g. >5 days prior to patient symptoms) such that it would allow an opportunity for earlier intervention with medical assessment and current therapeutic approaches.
The specific primary aim includes evaluation of the correlation of respiration rate parameters to indicators of healthcare utilization including drug changes, office or ER visits, hospitalization, or other clinical interventions. Secondary aims include evaluation of (i) the sensitivity and specificity of respiration rate monitoring results to predict COPD worsening requiring medical intervention, (ii) the sensitivity and specificity of respiration rate monitoring results in conjunction with COPD Co-PILOT scores or components to predict COPD worsening requiring medical intervention, and the correlation of respiration rate parameters to episode duration as defined by number of days from COPD Co-PILOT Score >1 to resolution (COPD Co-PILOT Score <1 for 7 consecutive days).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Respiration rate monitoring
Arm Type
Experimental
Arm Description
Reassure Non-Contact Respiration Monitor
Intervention Type
Device
Intervention Name(s)
Reassure Non-Contact Respiration Monitor
Intervention Description
Reassure Respiration Monitor uses very low power radio waves to detect respiratory movements of a person while asleep in bed - without physical contact with the individual. Algorithms analyze the respiratory movement signals and extract information about respiration rate and variability. This data is uploaded to a secure cloud infrastructure for storage.
Primary Outcome Measure Information:
Title
Correlation of Respiration Rate to Indicators of Healthcare Utilization
Description
Indicators of healthcare utilization include change in medications for COPD, number of office or ER visits, number of hospitalizations.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Sensitivity and Specificity of Respiration Rate to Predict COPD Worsening
Time Frame
Baseline to 12 weeks
Title
Sensitivity and Specificity of Respiration Rate in Conjunction with COPD Co-PILOT Scores to Predict COPD Worsening
Time Frame
12 weeks
Title
Correlation of Respiration Rate to COPD Episode Duration
Description
Episode duration is defined by number of days from COPD Co-PILOT Score >1 to resolution (COPD Co-PILOT Score <1 for 7 consecutive days)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males or females age ≥35 years old
Documented diagnosis of moderate to very severe COPD (GOLD Level II-IV)
Weight ≥35 kg
Currently using the COPD Co-PILOT application (at least 3 months with 70% compliance)
Must be able to read and understand English and consent for themselves
Exclusion Criteria:
Currently using any form of non-invasive positive airway pressure ventilation
Diagnosis of significant heart failure (NYHA Class III or IV)
Cognitive impairment (determined by physician) that will make it hard to follow instructions regarding device usage
BMI ≥45.5
Residing in hospice care, Skilled Nursing Facilities or Long Term Acute Care facilities
Currently using a wearable drug infusion pump to deliver medication
Planned procedures at time of enrollment that will occur within timeframe of study and require hospitalization etc.
Declines to participate at any time.
In the opinion of the Investigator, may be non-compliant with study schedules or procedures
No cellular coverage at their primary residence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerard Criner, MD
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
HGE Health Care Solutions
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19129
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Respiration Rate Monitoring in COPD Patients
We'll reach out to this number within 24 hrs