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COPD monitoring

Completed
Conditions
COPD
dyspnea
10038716
Registration Number
NL-OMON56095
Lead Sponsor
niversitair Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
31
Inclusion Criteria

1.Subject must have a clinical diagnosis of COPD
2. mMRC (Modified Medical Research Council) Dyspnea Scale Score > 1
3. Subject must be indicated for regular inpatient/outpatient pulmonary
rehabilitation at CIRO
4. Subject must be willing to provide Informed Consent for their participation
in the study
5. Subject must be >=18 years of age

Exclusion Criteria

1. Subjects who are unable/unwilling to voluntarily participate in the study
2.Subjects who cannot read/write
3. Subject has congenital heart disease
4.Subject has unstable coronary artery disease
5.Subject has an active implanted cardiac device (i.e. IPG, ICD)
6.Subject has heart failure NYHA 4
7.Subject presents any concomitant condition which in the opinion of the
investigator would not allow a safe participation in the study
8.Subject is legally incompetent
9.Subject is pregnant or has suspect to be pregnant
10.Subject is enrolled in a concurrent study that may confound the results of
this study without documented pre-approval from Medtronic study manager
11. BORG scale assessment is evaluated as unreliable due to patient*s cognitive
condition

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The primary objective and endpoint of the study is:<br /><br>• To evaluate the EMG of respiratory muscles during various levels of dyspnea<br /><br>and exertion in COPD patients. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>The secondary objectives of this study are:<br /><br>• To characterize EMG, respiration rate, SpO2 and patient-reported health<br /><br>information (about dyspnea and other symptoms) before, during and after acute<br /><br>exacerbations of COPD;<br /><br>• To characterize the respiration rate during various levels of dyspnea and<br /><br>exertion in COPD patients;<br /><br>•To characterize the SpO2during various levels of dyspnea and exertion in COPD<br /><br>patients.<br /><br><br /><br><br /><br><br /><br><br /><br>Secondary endpoints are:<br /><br>• Change in EMG, respiration rate, SpO2 and patient-reported health information<br /><br>(Exact-PRO) before, during and after exacerbations of COPD.<br /><br>• Correlation between respiration rate, as measured by the BioNomadix wearable<br /><br>data logger system, and Borg scale during exercise<br /><br>• Correlation between SpO2 as measured by the WristOx2 3150 wearable pulse<br /><br>oximeter, and Borg scale during exercise</p><br>
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