Chronic Obstructive Pulmonary Disease (COPD) Monitoring

COPD Clinical Trial

— COPD  

Official title:

Chronic Obstructive Pulmonary Disease (COPD) Monitoring

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04671888
• Other study ID #: MDT19035
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2021
• Est. completion date: November 2022

Study information

• Verified date: December 2020
• Source: Medtronic BRC
• Contact: Elisa Scaccianoce, PhD
• Phone: 3405351232
• Email: elisa.scaccianoce[@]medtronic.cm
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• COPD Exacerbation
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• exercises
COPD patients will be asked to wear a data logger system to collect EMG data and respiration parameters during exercise that simulate daily activity (i.e., walking, cycling)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic BRC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between EMG and BORG scale during sub-maximal constant work rate test (CWRT) exercise	To evaluate the correlation between EMG amplitude collected by means of the data logger system and BORG scale during sub-maximal CWRT exercise.	through study completion, an average of 3 months
Primary	Correlation between EMG and BORG scale during rehabilitation exercise	To evaluate the correlation between EMG amplitude collected by means of the data logger system and BORG scale during rehabilitation exercise .	through study completion, an average of 3 months
Secondary	EMG (Exacerbation symptoms assessment)	To evaluate the change of EMG amplitude between stable condition and an acute exacerbation episode	through study completion, an average of 3 months
Secondary	Respiration rate (Exacerbation symptoms assessment)	To evaluate the change of respiration rate between stable condition and an acute exacerbation episode	through study completion, an average of 3 months
Secondary	Transcutaneous oxygen saturation (Exacerbation symptoms assessment)	To evaluate the change of transcutaneous oxygen saturation between stable condition and an acute exacerbation episode	through study completion, an average of 3 months
Secondary	BORG scale (Exacerbation symptoms assessment)	To evaluate the change of BORG scale between stable condition and an acute exacerbation episode	through study completion, an average of 3 months
Secondary	Correlation between respiration rate and BORG scale	To evaluate the correlation between the respiration rate and BORG scale	through study completion, an average of 3 months
Secondary	Correlation between transcutaneous oxygen saturation and BORG scale	To evaluate the correlation between transcutaneous oxygen saturation and BORG scale	through study completion, an average of 3 months