Effect of Simeox® on Residual Volume in COPD Patients With Pulmonary Hyperinflation (SIMEO-RV COPD)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease (COPD); Pulmonary Hyperinflation
• Intervention / Treatment: Device: Simeox

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 23
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea Di Matteo, dr; Phone Number: +393387123135; Email: andrea.dimatteo@asst-lodi.it

Study Locations

• Italy
  • Lombardy
    • Codogno, Lombardy, Italy, 26845
      • Recruiting
      • ASST Lodi - Presidio Ospedaliero di Codogno
      • Contact: Andrea Di Matteo, dr; Phone Number: +393387123135; Email: andrea.dimatteo@asst-lodi.it
      • Contact: Email: dimatteo.fisio@gmail.com
      • Principal Investigator: Andrea Di Matteo, dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Unstable cardiovascular conditions, including:
• Recent myocardial infarction
• Unstable angina
• Uncontrolled arrhythmias
• Unstable heart failure
• Recent cardiothoracic surgery (< 3 months), including oesophageal surgery
• Recent thoracic trauma or severe acute lung injury
• Continuous mechanical ventilation, active need for inspiratory assistance, or tracheostomy
• Neuromuscular diseases with respiratory muscle weakness
• Inspiratory muscle weakness precluding increased respiratory effort
• Oropharyngeal or oral muscle weakness
• Inability to cough effectively, forcefully and autonomously
• Severe restrictive lung disease (TLC < 60% of predicted)
• Airways at risk of aspiration (e.g. recent nasogastric tube feeding)
• Uncontrolled gastro-oesophageal reflux disease (GERD)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Simeox Treatment; 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.; Other Names: Intermittent Negative Pressure Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline and within 30 minutes after the end of the treatment session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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)	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	From the start of the treatment session up to 30 minutes after session completion

Collaborators and Investigators

• Sponsor: Azienda Socio Sanitaria Territoriale di Lodi

Publications and helpful links

General Publications

• Wanger J, Clausen JL, Coates A, Pedersen OF, Brusasco V, Burgos F, Casaburi R, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson D, Macintyre N, McKay R, Miller MR, Navajas D, Pellegrino R, Viegi G. Standardisation of the measurement of lung volumes. Eur Respir J. 2005 Sep;26(3):511-22. doi: 10.1183/09031936.05.00035005. No abstract available.
• Puente-Maestu L, Stringer WW. Hyperinflation and its management in COPD. Int J Chron Obstruct Pulmon Dis. 2006;1(4):381-400. doi: 10.2147/copd.2006.1.4.381.
• . Chow SC, Shao J, Wang H. Sample Size Calculations in Clinical Research. 2nd ed. Boca Raton: Chapman & Hall/CRC; 2008.
• Hartman JE, Ten Hacken NH, Klooster K, Boezen HM, de Greef MH, Slebos DJ. The minimal important difference for residual volume in patients with severe emphysema. Eur Respir J. 2012 Nov;40(5):1137-41. doi: 10.1183/09031936.00219111. Epub 2012 Mar 22.
• Fessler HE, Scharf SM, Permutt S. Improvement in spirometry following lung volume reduction surgery: application of a physiologic model. Am J Respir Crit Care Med. 2002 Jan 1;165(1):34-40. doi: 10.1164/ajrccm.165.1.2101149.
• Hopkinson NS, Toma TP, Hansell DM, Goldstraw P, Moxham J, Geddes DM, Polkey MI. Effect of bronchoscopic lung volume reduction on dynamic hyperinflation and exercise in emphysema. Am J Respir Crit Care Med. 2005 Mar 1;171(5):453-60. doi: 10.1164/rccm.200407-961OC. Epub 2004 Dec 3.
• O'Donnell DE, Laveneziana P. Dyspnea and activity limitation in COPD: mechanical factors. COPD. 2007 Sep;4(3):225-36. doi: 10.1080/15412550701480455.
• Garcia-Rio F, Lores V, Mediano O, Rojo B, Hernanz A, Lopez-Collazo E, Alvarez-Sala R. Daily physical activity in patients with chronic obstructive pulmonary disease is mainly associated with dynamic hyperinflation. Am J Respir Crit Care Med. 2009 Sep 15;180(6):506-12. doi: 10.1164/rccm.200812-1873OC. Epub 2009 Jun 19.
• Cooper CB. The connection between chronic obstructive pulmonary disease symptoms and hyperinflation and its impact on exercise and function. Am J Med. 2006 Oct;119(10 Suppl 1):21-31. doi: 10.1016/j.amjmed.2006.08.004.
• Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2024.

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 4, 2026
• First Submitted That Met QC Criteria: June 18, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: COPD; Dyspnea; Spirometry; Intermittent Negative Pressure; Pilot Study; Respiratory Physiotherapy; Residual Volume; Pulmonary Hyperinflation; Simeox; Lung Volumes; Air Trapping; airway Clearance; Nitrogen Washout
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Lung Diseases, Obstructive; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Dyspnea
• Other Study ID Numbers: CET 100-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No