Clinical trial NCT03030313: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2017-01-25
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Correlation of Respiration Rate to Indicators of Healthcare Utilization
timeFrame: 12 weeks
Secondary outcomes:
measure: Sensitivity and Specificity of Respiration Rate to Predict COPD Worsening
timeFrame: Baseline to 12 weeks
measure: Sensitivity and Specificity of Respiration Rate in Conjunction with COPD Co-PILOT Scores to Predict COPD Worsening
timeFrame: 12 weeks
measure: Correlation of Respiration Rate to COPD Episode Duration
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: HGE Health Care Solutions
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Gerard Criner, MD
role: PRINCIPAL_INVESTIGATOR
References: