Respiration Rate Monitoring in COPD Patients

NCT ID: NCT03030313

Last Updated: 2017-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-01
• Study Completion Date: 2017-07-26

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).

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Respiration rate monitoring

Reassure Non-Contact Respiration Monitor

Group Type: EXPERIMENTAL

Reassure Non-Contact Respiration Monitor

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ResMed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerard Criner, MD

Role: PRINCIPAL_INVESTIGATOR

Temple University

Locations

HGE Health Care Solutions

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

MA-16-05-01

Identifier Type: -

Identifier Source: org_study_id