Comparison Between Conventional Respiratory Physiotherapy and the Simeox Device in Patients With Bronchiectasis

NCT06801327 · tracked via the Priya Life Science Italy tracker

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Phase

Not applicable

Started

2024-12-01

Last updated

2026-03-02

Condition(s) studied

Bronchiectasis Adult

Investigational drug(s) / intervention(s)

Simeox

Simeox: The Investigators chose to evaluate this device for respiratory physiotherapy in our patients because it is the only one that offers innovative technology, as, unlike other commercially available devices, it does not require the patient to perform forced breathing. Instead, the patient can exhale calmly at tidal volume. This is expected to reduce the patient's effort and improve compliance with treatment. Furthermore, the vibratory signal with small, rapid, and sequential depressions within the airways could be more effective in mobilizing mucus from the airways, preventing collapse.

Study summary

Physiotherapy is a key treatment for patients with bronchiectasis. An evaluation of the parameters indicative of respiratory health in patients treated with two different respiratory physiotherapy techniques (conventional versus Simeox®) would be very useful in choosing physiotherapy treatments for bronchiectasis patients. A systematic review of the literature shows that there are no published studies evaluating the effectiveness of respiratory physiotherapy by analyzing the variation in resistance measured using the forced oscillation technique (FOT) in patients with bronchiectasis. The results of this study would add to those that have examined different physiotherapy techniques and could therefore contribute to the choice of the most appropriate technique for this category of patients.

The trial is being conducted to answer the question: "How do respiratory parameters vary during treatment with two different respiratory physiotherapy techniques: conventional respiratory physiotherapy or that performed using the Simeox device?" Secondary objectives include the measurement of various functional parameters, such as vital signs (heart rate, respiratory rate, blood oxygenation, blood pressure values) and spirometry values (FEV1, FVC, TLC). The onset of adverse events, the degree of patient tolerance and relief, and respiratory health will also be assessed through the administration of various questionnaires commonly used in clinical practice. Additionally, changes in the quantity of sputum produced will be measured.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Patients with a diagnosis of bronchiectasis not due to cystic fibrosis who are not hospitalized. * Age ≥ 18 years. * Evidence of bronchiectasis in at least one lung lobe from a chest CT scan performed within the 10 years prior to enrollment. * Absence of exacerbations in the 28 days preceding enrollment. * Sputum producers with volumes less than or equal to 200 mL/day. * Under treatment with optimized standard therapy for bronchiectasis that has been stable for at least one year, with no changes in the 28 days prior to enrollment. * Eligible for and/or already undergoing respiratory physiotherapy. * Signed informed consent. Exclusion Criteria: * Diagnosis of COPD or bronchial asthma interpreted as primary and predominant diseases compared to bronchiectasis. * Presence of tracheostomy. * History of significant hemoptysis (≥300 mL of blood) or requiring embolization or blood transfusions in the 4 weeks preceding enrollment. * Hemodynamic instability (mean arterial pressure \< 65 mmHg, heart rate \> 110 bpm). * Undrained pneumothorax (evident on chest X-ray, deemed not worthy of pleural drainage according to standard clinical-assistance pathways and thus subjected to follow-up). * Women who are pregnant or breastfeeding.

Primary outcome measure(s)

Measurement of respiratory mechanics (airway resistance) — V1 (Baseline,) Visit 2 (Day 7), Visit 3 (Week 5), Visit 4 (Week 6), Visit 5 (Week 10)
Airway resistance at 5 Hz (R5) and airway resistance at 20 Hz (R20) measured in cmH2O/L/sec, using Forced Oscillometry Technique (FOT)

Trial sites (1)

Facility	City	Region	Status
Respiratory and Critical Care Unit, IRCCS Azienda Ospedaliera-Universitaria di Bologna	Bologna	Bologna	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06801327 on ClinicalTrials.gov ↗ ← All trials in Italy