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

NCT07665931 | Recruiting

• 1 other identifier: CET 100-2026
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Chronic Obstructive Pulmonary Disease (COPD); Pulmonary Hyperinflation

Keywords

COPD; Pulmonary Hyperinflation; Residual Volume; Air Trapping; Simeox; Intermittent Negative Pressure; airway Clearance; Lung Volumes; Nitrogen Washout; Spirometry; Dyspnea; Respiratory Physiotherapy; Pilot Study

Outcome Measures

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

  Baseline and within 30 minutes after the end of the treatment session

Secondary Outcomes (5)

• Change in Functional Residual Capacity (FRC)

  Baseline and within 30 minutes after the end of the treatment session

• Change in Vital Capacity (VC)

  Baseline and within 30 minutes after the end of the treatment session

• Change in Dyspnea Score

  Baseline and within 30 minutes after the end of the treatment session

• Incidence of Adverse Events

  From the start of the treatment session up to 30 minutes after session completion

• Treatment Tolerability

  From the start of the treatment session up to 30 minutes after session completion

Study Arms (1)

Simeox Treatment

EXPERIMENTAL

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

Interventions

Simeox DEVICE

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

Simeox Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale di Lodi: lead

Study Sites (1)

ASST Lodi - Presidio Ospedaliero di Codogno

Codogno, Lombardy, 26845, Italy

RECRUITING

Related Publications (10)

• . Chow SC, Shao J, Wang H. Sample Size Calculations in Clinical Research. 2nd ed. Boca Raton: Chapman & Hall/CRC; 2008.

  BACKGROUND

• 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.

  PMID: 22441742 BACKGROUND

• 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.

  PMID: 11779727 BACKGROUND

• 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.

  PMID: 15579725 BACKGROUND

• 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.

  PMID: 16135736 BACKGROUND

• O'Donnell DE, Laveneziana P. Dyspnea and activity limitation in COPD: mechanical factors. COPD. 2007 Sep;4(3):225-36. doi: 10.1080/15412550701480455.

  PMID: 17729066 BACKGROUND

• 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.

  PMID: 19542481 BACKGROUND

• 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.

  PMID: 18044095 BACKGROUND

• 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.

  PMID: 16996896 BACKGROUND

• Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2024.

  BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Central Study Contacts

Andrea Di Matteo, dr

CONTACT

+393387123135; andrea.dimatteo@asst-lodi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: June 24, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)