Impact of Bronchial Drainage Technique by the Medical Device Simeox® on Respiratory Function and Symptoms in Adult Patients With Cystic Fibrosis

Study Overview
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Brief Summary
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The main objective of the study is to evaluate the short-term effects of the airway clearance technique by the medical device Simeox (Physio Assist, France) versus Autogenic Drainage, on the pulmonary function of adult patients with stable cystic fibrosis. To analyse these effects, the investigators used forced oscillation technique measured by TremoFlo™ C-100 Airwave Oscillometry System™ (THORASYS Thoracic Medical Systems Inc. Montreal, Quebec, Canada) with an evaluation of the perceived clinical benefits.

Official Title
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Impact of Bronchial Drainage by the Medical Device Simeox® on Function and Respiratory Symptoms Compared to Manual Autogenous Drainage Physiotherapy in Adult Cystic Fibrosis Patients

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Device: SIMEOX
* Other: Autogenic drainage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of cystic fibrosis confirmed Age ≥18 years 30% <FEV1 <70% predicted Presence of bronchial congestion reported by the patient or the investigator Exclusion Criteria: Uncontrolled asthma Pneumothorax <6 weeks Recent severe hemoptysis <6 weeks Patient registered on the transplant list Exacerbation within 4 weeks (3 months if hospitalization) before screening Cardiovascular disorders, electrocardiogram (ECG) parameters or clinically significant respiratory (non-cystic fibrosis) conditions Patients unable to perform measurements of ROF, spirometry, plethysmography. Any contraindication to manual or instrumental physiotherapy. Pregnancy, breastfeeding. Patient under tutorship or curatorship No affiliation to the French social security Patient using Simeox at home Patient under Trikafta for less than 6 weeks. Patient using Simeox more than twice a week during physiotherapy sessions, not wanting a washout period of 7 days before inclusion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SIMEOX<br> | Other: Autogenic drainage<br>* Manual aiway clearance by autogenic drainage<br>|
| Active Comparator: Autogenic Drainage<br> | Device: SIMEOX<br>* Instrumental airway clearance by the medical device SIMEOX<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low frequency resistance R5 | Comparison of variations V4 and V8 sessions (pre and post airway clearance session) | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the impact of Simeox® bronchial drainage compared to autogenous drainage on respiratory symptoms: dyspnea, congestion and fatigue |  | 1 month | 
| Evaluation of the distal and / or proximal decluttering by the two techniques, according to the improvement profile of the forced oscillations |  | 1 month | 
| Evaluation of the impact of Simeox® bronchial drainage vs autogenous drainage by spirometry and plethysmography (distension and resistance) |  | 1 month | 
| Evaluation of correlations between clinical benefit and changes in functional respiratory investigations (forced oscillations, spirometry, plethysmography) |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cystic Fibrosis, Physiotherapy, Drainage