Comparison Between Conventional Respiratory Physiotherapy and the Simeox Device in Patients With … (NCT06801327) | Clinical Trial Compass
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Comparison Between Conventional Respiratory Physiotherapy and the Simeox Device in Patients With Bronchiectasis
Italy40 participantsStarted 2024-12-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Measurement of respiratory mechanics (airway resistance)