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ID06801327

Study Comparing Conventional Respiratory Physiotherapy and the Simeox Device in Adults with Bronchiectasis

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2026-03-02

40

Participants Needed

1

Research Sites

13 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating respiratory health in adults with bronchiectasis by comparing two types of respiratory physiotherapy conventional techniques and a device called Simeox. This study aims to understand how these methods affect airway resistance and other breathing-related measures. It addresses a gap in knowledge, as no prior studies have used forced oscillation technique FOT to assess these treatments in bronchiectasis patients. The study also monitors patient comfort, sputum production, and overall respiratory health through questionnaires and functional tests. This is a single-center, open-label, randomized crossover study where participants receive both types of physiotherapy in different sequences. Each treatment period lasts 4 weeks and is separated by a 1-week wash-out phase to allow mucus to return to baseline levels. Group A starts with conventional physiotherapy using devices like Acapella and PEP masks, then switches to Simeox, while Group B begins with Simeox and then switches to conventional therapy. Patients already receiving physiotherapy undergo a wash-out before starting the study. The Simeox device offers a unique approach by allowing calm exhalation and delivering vibrations to mobilize mucus without forced breathing. Participants will attend visits at baseline, day 7, week 5, week 6, and week 10 to measure airway resistance, vital signs heart rate, respiratory rate, oxygen levels, blood pressure, spirometry, and walking capacity. Adverse events, patient tolerance, sputum amount and quality, dyspnea level, and quality of life will be assessed using common questionnaires. The study lasts about 10 weeks, including treatment and wash-out periods, to comprehensively evaluate the effects and acceptability of both physiotherapy techniques in bronchiectasis patients.

CONDITIONS

Brief Title

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

Research Team

S

Stefano Nava, MD

V

Vittoria Comellini, MD

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