Respiration Rate Monitoring in COPD Patients
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|ClinicalTrials.gov Identifier: NCT03030313|
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : November 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Disease, Chronic Obstructive||Device: Reassure Non-Contact Respiration Monitor||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- Sensitivity and Specificity of Respiration Rate to Predict COPD Worsening [ Time Frame: Baseline to 12 weeks ]
- Sensitivity and Specificity of Respiration Rate in Conjunction with COPD Co-PILOT Scores to Predict COPD Worsening [ Time Frame: 12 weeks ]
- 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)
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
|United States, Pennsylvania|
|HGE Health Care Solutions|
|Philadelphia, Pennsylvania, United States, 19129|
|Principal Investigator:||Gerard Criner, MD||Temple University|