Respiration Rate Monitoring in COPD Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Device: Reassure Non-Contact Respiration Monitor

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).

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19129
      • HGE Health Care Solutions

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Respiration rate monitoring; Reassure Non-Contact Respiration Monitor

Device: Reassure Non-Contact Respiration Monitor; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and Specificity of Respiration Rate to Predict COPD Worsening		Baseline to 12 weeks
Sensitivity and Specificity of Respiration Rate in Conjunction with COPD Co-PILOT Scores to Predict COPD Worsening		12 weeks
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)	12 weeks

Collaborators and Investigators

• Sponsor: ResMed
• Investigators: Principal Investigator: Gerard Criner, MD, Temple University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): July 26, 2017
• Study Completion (Actual): July 26, 2017

Study Registration Dates

• First Submitted: November 18, 2016
• First Submitted That Met QC Criteria: January 20, 2017
• First Posted (Estimate): January 25, 2017

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: November 14, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: MA-16-05-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO