Clinical trial NCT04671888: Chronic Obstructive Pulmonary Disease (COPD) Monitoring
Official title: Chronic Obstructive Pulmonary Disease (COPD) Monitoring
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
COPD Exacerbation
Lead sponsor: Medtronic BRC
Sponsor class: INDUSTRY
First posted: 2020-12-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The present feasibility study aims at assessing whether the EMG of respiratory muscles can serve as an objective marker of dyspnea in COPD patients.

The study aims also at evaluating the changes in physiological parameters (i.e., EMG, respiration rate, heart rate, temperature, and SpO2) occurring when simulating daily activities before, during and after acute exacerbations. All this information can be useful to detect the exacerbations earlier or to provide better treatment during the exacerbations.


Eligibility criteria: Inclusion Criteria:

* Subject must have a clinical diagnosis of COPD
* mMRC (Modified Medical Research Council) Dyspnea Scale Score \> 1
* Subject must be indicated for regular inpatient pulmonary rehabilitation
* Subject must be hyperinflated, defined as residual volume (RV)\>120% of the predicted value, measured by whole body plethysmography
* Subject must be willing to provide Informed Consent for their participation in the study
* Subject must be ≥18 years of age

Exclusion Criteria:

* Subjects who are unable/unwilling to voluntarily participate in the study
* Subjects who cannot read/write
* Subjects who are dependent on oxygen and/or unfit to wear a mask during sub- maximal constant work rate test (CWRT)
* Subject has congenital heart disease
* Subject has unstable coronary artery disease
* Subject has an active implanted cardiac device (i.e. IPG, ICD)
* Subject has heart failure NYHA 4
* Subject presents any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study
* Subject is legally incompetent
* Subject is pregnant or has suspect to be pregnant
* Subject is enrolled in a concurrent study that may confound the results of this study without documented pre-approval from Medtronic study manager
* BORG scale assessment is evaluated as unreliable due to patient's cognitive condition

Primary outcomes:
measure: Correlation between EMG and BORG scale during sub-maximal constant work rate test (CWRT) exercise
timeFrame: through study completion, an average of 3 months
measure: Correlation between EMG and BORG scale during rehabilitation exercise
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
measure: EMG (Exacerbation symptoms assessment)
timeFrame: through study completion, an average of 3 months
measure: Respiration rate (Exacerbation symptoms assessment)
timeFrame: through study completion, an average of 3 months
measure: Transcutaneous oxygen saturation (Exacerbation symptoms assessment)
timeFrame: through study completion, an average of 3 months
measure: BORG scale (Exacerbation symptoms assessment)
timeFrame: through study completion, an average of 3 months
measure: Correlation between respiration rate and BORG scale
timeFrame: through study completion, an average of 3 months
measure: Correlation between transcutaneous oxygen saturation and BORG scale
timeFrame: through study completion, an average of 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Center of Expertise for Chronic Organ Failure
name: Martijn Spruit
role: PRINCIPAL_INVESTIGATOR
References: