Respiration Rate Monitoring in COPD Patients

NCT03030313 | Completed

• 1 other identifier: MA-16-05-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

  12 weeks

Study Arms (1)

Respiration rate monitoring

EXPERIMENTAL

Reassure Non-Contact Respiration Monitor

Device: Reassure Non-Contact Respiration Monitor

Interventions

Reassure Non-Contact Respiration Monitor DEVICE

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.

Respiration rate monitoring

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ResMed: lead

Study Sites (1)

HGE Health Care Solutions

Philadelphia, Pennsylvania, 19129, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gerard Criner, MD

  Temple University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2016
• First Posted: January 25, 2017
• Study Start: December 1, 2016
• Primary Completion: July 26, 2017
• Study Completion: July 26, 2017
• Last Updated: November 17, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)