RecruitingNot ApplicableNCT07665931

Effect of Simeox® on Residual Volume in COPD Patients With Pulmonary Hyperinflation

Prospective, Uncontrolled, Single-arm, Interventional Study With Pre-post Intervention Assessment on the Effect of the Simeox® Electro-medical Device on Residual Volume in Patients With COPD and Pulmonary Hyperinflation


Sponsor

Azienda Socio Sanitaria Territoriale di Lodi

Enrollment

23 participants

Start Date

May 5, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Brief Summary People with severe chronic obstructive pulmonary disease (COPD) often have too much air trapped in their lungs (pulmonary hyperinflation). This makes it hard to breathe and reduces quality of life. This study tests whether a single session with a medical device called Simeox® can reduce the amount of air trapped in the lungs. Simeox® works by applying gentle intermittent negative pressure during exhalation to help air move out of the lungs more easily. Patients with severe or very severe COPD and documented hyperinflation will undergo lung function measurements before and immediately after a 20-minute Simeox® session. The main measurement is the change in residual volume (RV), which is the amount of air left in the lungs after a full exhalation. We will also measure changes in other lung volumes, breathlessness, and any side effects. This is a single-arm pilot study enrolling 23 patients at one center in Italy (ASST Lodi). The study is non-profit and has been approved by the Ethics Committee Comitato Etico Territoriale Lombardia 1 (CET Lombardia 1).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Simeox for people with chronic obstructive pulmonary disease (copd) and pulmonary hyperinflation. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICESimeox

Single treatment session of approximately 20 minutes with the Simeox® electro-medical device. The session consists of 4 series of 10 tidal breathing cycles performed in a seated position, with rest breaks according to patient tolerance. During each breathing cycle, the patient performs slow controlled exhalations while the device applies high-frequency intermittent negative pressure (6-12 Hz), modulated to the maximum tolerated intensity. Treatment efficacy is monitored through visual indicators integrated into the device.


Locations(1)

ASST Lodi - Presidio Ospedaliero di Codogno

Codogno, Lombardy, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07665931


Related Trials