NCT07665931Recruiting
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
Source: ClinicalTrials.gov · Last updated 24 Jun 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 23 (estimated)
- First submitted
- 4 May 2026
- Start date
- 5 May 2026
- Primary completion date
- Sept 2026
- Lead sponsor
- Azienda Socio Sanitaria Territoriale di Lodi
- Diseases
- COPD
- NCT number
- NCT07665931
What you commit to
- Study type: Interventional
- Planned participants: 23
- From 5 May 2026 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent cardiothoracic surgery (\< 3 months), including oesophageal surgery
Other illness
- Active or recent gross haemoptysis (\< 6 weeks) or active pulmonary haemorrhage
- Unstable cardiovascular conditions, including:
- Recent myocardial infarction
- Unstable angina
- Uncontrolled arrhythmias
- Unstable heart failure
- Neuromuscular diseases with respiratory muscle weakness
- Severe restrictive lung disease (TLC \< 60% of predicted)
- Uncontrolled gastro-oesophageal reflux disease (GERD)
Other
- Active or recent pneumothorax (\< 6 weeks), predisposition to pneumothorax or pneumomediastinum, or known pleural fragility
- Haemodynamic instability
- Recent thoracic trauma or severe acute lung injury
- Continuous mechanical ventilation, active need for inspiratory assistance, or tracheostomy
- Inspiratory muscle weakness precluding increased respiratory effort
- Oropharyngeal or oral muscle weakness
- Inability to cough effectively, forcefully and autonomously
- Airways at risk of aspiration (e.g. recent nasogastric tube feeding)
Who the study is looking for
- Age ≥ 18 years
- Diagnosis of severe or very severe COPD (GOLD stage 3-4)
- Documented pulmonary hyperinflation defined by at least one of the following criteria measured by nitrogen wash-out (N₂ wash-out):
- Residual volume (RV) \> 150% of predicted
- Functional residual capacity (FRC) \> 130% of predicted
- Total lung capacity (TLC) \> 120% of predicted
- RV/TLC ratio \> 40%
- Clinical stability (no exacerbations in the 3 weeks prior to enrollment)
- Patients for whom assessment of the effect of Simeox® on reduction of pulmonary hyperinflation is considered clinically appropriate, in the context of exploratory device use
- Written informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ASST Lodi - Presidio Ospedaliero di Codogno Coordinator of this site? Confirm its status | Codogno | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.