Effect of Simeox® on Residual Volume in COPD Patients With Pulmonary Hyperinflation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAzienda Socio Sanitaria Territoriale di Lodi
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Diagnosis of severe or very severe COPD (GOLD stage 3-4)
Residual volume (RV) > 150% of predicted
Functional residual capacity (FRC) > 130% of predicted
Disqualifiers
Active or recent pneumothorax (< 6 weeks), predisposition to pneumothorax or pneumomediastinum, or known pleural fragility
Active or recent gross haemoptysis (< 6 weeks) or active pulmonary haemorrhage
Haemodynamic instability
Recent myocardial infarction
Trial design
Design model
Single group
Treatments tested in this trial
Simeox
DeviceSingle 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.
Treatment groups
23 Participants
are divided into 1 treatment groupGroup A: Simeox TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Residual Volume (RV)
Absolute change in residual volume (ΔRV, liters) measured by nitrogen wash-out (N₂ wash-out) before and immediately after a single Simeox® treatment session
Time frame
Baseline and within 30 minutes after the end of the treatment sessionSecondary outcomes
1
Change in Functional Residual Capacity (FRC)
Absolute change in functional residual capacity (ΔFRC, liters) measured by nitrogen wash-out (N₂ wash-out) before and immediately after the treatment session
Time frame
Baseline and within 30 minutes after the end of the treatment session2
Change in Vital Capacity (VC)
Absolute change in vital capacity (ΔVC, liters) measured by spirometry before and immediately after the treatment session
Time frame
Baseline and within 30 minutes after the end of the treatment session3
Change in Dyspnea Score
Change in dyspnea assessed using the modified Borg CR10 scale (range 0-10; higher scores indicate greater dyspnea) before and immediately after the treatment session
Time frame
Baseline and within 30 minutes after the end of the treatment session4
Incidence of Adverse Events
Number and type of adverse events classified by severity (mild, moderate, severe) and relationship to the treatment (related, probably related, unrelated)
Time frame
From the start of the treatment session up to 30 minutes after session completionSponsors and contacts
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Source ClinicalTrials.gov