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Respiration Rate Monitoring in COPD Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03030313
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
ResMed

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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Device: Reassure Non-Contact Respiration Monitor Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : December 1, 2016
Actual Primary Completion Date : July 26, 2017
Actual Study Completion Date : July 26, 2017

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.




Primary Outcome Measures :
  1. Correlation of Respiration Rate to Indicators of Healthcare Utilization [ Time Frame: 12 weeks ]
    Indicators of healthcare utilization include change in medications for COPD, number of office or ER visits, number of hospitalizations.


Secondary Outcome Measures :
  1. Sensitivity and Specificity of Respiration Rate to Predict COPD Worsening [ Time Frame: Baseline to 12 weeks ]
  2. Sensitivity and Specificity of Respiration Rate in Conjunction with COPD Co-PILOT Scores to Predict COPD Worsening [ Time Frame: 12 weeks ]
  3. Correlation of Respiration Rate to COPD Episode Duration [ Time Frame: 12 weeks ]
    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)



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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030313


Locations
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United States, Pennsylvania
HGE Health Care Solutions
Philadelphia, Pennsylvania, United States, 19129
Sponsors and Collaborators
ResMed
Investigators
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Principal Investigator: Gerard Criner, MD Temple University
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Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT03030313    
Other Study ID Numbers: MA-16-05-01
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive