Actively Recruiting
Comparison Between Conventional Respiratory Physiotherapy and the Simeox Device in Patients With Bronchiectasis
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2026-03-02
40
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparison Between Conventional Respiratory Physiotherapy and the Simeox Device in Patients With Bronchiectasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a diagnosis of bronchiectasis not due to cystic fibrosis who are not hospitalized
- Age 18 years or older
- Evidence of bronchiectasis in at least one lung lobe from a chest CT scan performed within the past 10 years
- No exacerbations in the 28 days before enrollment
- Sputum production less than or equal to 200 mL per day
- Stable optimized standard therapy for bronchiectasis for at least one year with no changes in the 28 days before enrollment
- Eligible for or already undergoing respiratory physiotherapy
- Signed informed consent
You will not qualify if you...
- Diagnosis of COPD or bronchial asthma as the primary and predominant disease over bronchiectasis
- Presence of tracheostomy
- History of significant hemoptysis (300 mL or more) or requiring embolization or blood transfusion in the 4 weeks before enrollment
- Hemodynamic instability (mean arterial pressure below 65 mmHg or heart rate above 110 bpm)
- Undrained pneumothorax seen on chest X-ray that does not require pleural drainage
- Women who are pregnant or breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
Respiratory and Critical Care Unit, IRCCS Azienda Ospedaliera-Universitaria di Bologna
Bologna, Bologna, Italy, 40138
Actively Recruiting
Research Team
S
Stefano Nava, MD
CONTACT
V
Vittoria Comellini, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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