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RECRUITING
NCT06801327
NA

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

Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

View on ClinicalTrials.gov

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.

Official title: Comparison Between Different Respiratory Physiotherapy Techniques in Patients With Bronchiectasis. Conventional Therapy Versus Simeox: a Single-center, Randomized, Controlled, Cross-over Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-12-01

Completion Date

2026-12-01

Last Updated

2026-03-02

Healthy Volunteers

No

Interventions

DEVICE

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.

Locations (1)

Respiratory and Critical Care Unit, IRCCS Azienda Ospedaliera-Universitaria di Bologna

Bologna, Bologna, Italy