An interventional study of Simeox in Chronic Obstructive Pulmonary Disease (COPD) and Pulmonary Hyperinflation, sponsored by Azienda Socio Sanitaria Territoriale di Lodi. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Azienda Socio Sanitaria Territoriale di Lodi · Not applicable, Interventional, and Treatment
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).
Detailed Description Pulmonary hyperinflation is a key pathophysiological feature of advanced chronic obstructive pulmonary disease (COPD), resulting from air trapping due to airflow obstruction and reduced elastic recoil. It is strongly associated with dyspnea, exercise intolerance, and impaired quality of life. Reducing residual volume (RV) is therefore a clinically meaningful therapeutic target in patients with severe and very severe COPD.
Simeox® is a CE-marked electro-medical device currently used in clinical practice for bronchial secretion drainage. It applies intermittent negative pressure at high frequency (6-12 Hertz, Hz) during the expiratory phase, with the aim of increasing expiratory flow velocity and promoting air mobilization. While the device is routinely used in patients with bronchial hypersecretion, its potential effect on static lung volumes in patients with hyperinflation - regardless of the presence of significant secretions - has not been systematically investigated.
This prospective, single-arm, non-controlled pilot study aims to explore the immediate effect of a single Simeox® session on RV in patients with severe or very severe COPD and documented pulmonary hyperinflation.
Study procedure:
Each participant undergoes baseline lung function assessment using spirometry and nitrogen wash-out (N₂ wash-out), followed by a single Simeox® treatment session lasting approximately 20 minutes (4 series of 10 tidal breathing cycles in a seated position, with rest breaks according to tolerance). During each breathing cycle, the patient performs slow controlled exhalations while the device applies high-frequency intermittent negative pressure modulated to the maximum tolerated intensity. Lung function measurements are repeated immediately after the session (within 30 minutes).
Safety monitoring:
Respiratory rate, heart rate, and peripheral oxygen saturation (SpO₂) are monitored throughout the session. Adverse events are recorded and classified by type, severity, and relationship to the treatment. Tolerability is assessed through subjective patient rating and dyspnea score variation.
Statistical analysis:
Pre- and post-intervention comparisons will be performed using a paired t-test or Wilcoxon signed-rank test depending on data distribution (significance level p \< 0.05). Sample size was calculated based on a clinically meaningful RV reduction of 0.40 L (standard deviation, SD: 0.60 L), yielding a minimum of 21 patients (80% power, α = 0.05), with 23 patients planned to account for dropouts.
This pilot study will provide the methodological basis for designing a future randomized controlled trial (RCT) with a larger sample and longer follow-up.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 23 is below the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Azienda Socio Sanitaria Territoriale di Lodi is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All enrolled patients undergo a single session of treatment with the Simeox® device. Lung function is assessed before and immediately after the session. No control or comparator group is included.
Device: Simeox
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.
Also known as: Intermittent Negative Pressure Device
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 session
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 session
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 session
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 session
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 completion
Treatment Tolerability
Tolerability assessed by subjective patient rating at the end of the session (tolerated / poorly tolerated / not tolerated) and by the need to interrupt or modify the session due to discomfort or adverse symptoms
Time frame: From the start of the treatment session up to 30 minutes after session completion
Plan to share: No — Individual participant data will not be shared, given the exploratory and pilot nature of the study, the small sample size (23 patients), and the need to protect participant privacy in accordance with Italian and European data protection regulations (GDPR). Aggregate results will be made publicly available through publication in a peer-reviewed journal and/or presentation at scientific conferences within 12 months of study completion, as required by the approving Ethics Committee (CET Lombardia 1).
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pulmonary Disease, Chronic Obstructive →
Azienda Socio Sanitaria Territoriale di Lodi