Continous monitoring of ventilation with the Hexoskin smart shirt to detect dynamic hyperinflation in COPD patients.

Recruiting

• Conditions: dynamic hyperinflation; COPD; Hexoskin; dyspnea; dyspneu; metronome - paced tachypnea; hyperinflatie

• Registration Number: NL-OMON21984
• Lead Sponsor: Medisch Spectrum Twente, Enschede

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 45

Inclusion Criteria

Phase 1:

- Healthy adult control subjects

Exclusion Criteria

- Inability to fit the available shirts

- Physical impairments preventing the execution of a physical task

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between the lung function equipment and the Hexoskin smart shirt for the detection of dynamic hyperinflation in patients with COPD.

Secondary Outcome Measures

Name	Time	Method
The degree of dynamic hyperinflation<br /><br>- Cohen's kappa to assess the level of agreement between the two used methods.<br /><br>- Linear regression to describe the correlation<br /><br>- Sensitivity and specificity in the detection of dynamic hyperinflation under the assumption that lung function equipment serves as gold standard. <br /><br>- Bland Altman analyssis<br /><br>- User experience of the smart shirt