Effects of SIMEOX on Airway Clearance in Cystic Fibrosis

Study Overview
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Brief Summary
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This study will investigate the contribution of SIMEOX technology on the effectiveness of bronchial drainage. This is a crossover study to evaluate the contribution of SIMEOX on the effectiveness of bronchial drainage (verified by the amount of sputum secretions, the rheology of sputum secretions and the subjective sensation of ease of sputum) in patients with cystic fibrosis. Patients will perform, in randomized order (1) a 30-min session of autogenic drainage, (2) a 30-min session of autogenic drainage with the SIMEOX device. Sputum will be collected during and after the session. The two sessions will be performed with minimum washout time of 24 hours.

Official Title
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Effects of the Addition of the SIMEOX Device on Autogenic Drainage in Patients With Cystic Fibrosis

Conditions
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Cystic Fibrosis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults with cystic fibrosis Chronic bronchorrhea, able to expectorate by themselves Hospitalized Exclusion Criteria: Regular use of SIMEOX, Difficulties in understanding instructions, Severe cardiac comorbidity.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Active Comparator: Autogenic drainage<br>Patients will have to perform a 30-min session of autogenic drainage. Sputum will be collected during the session. | Other: Autogenic drainage<br>* Autogenic drainage is an airway clearance technique characterised by breathing control using expiratory airflow to mobilise secretions from smaller to larger airways. The secretions will be collected during the physiotherapy session and during the 24 hours following the session.<br>|
| Active Comparator: SIMEOX + Autogenic drainage<br>Patients will have to perform a 30-min session of autogenic drainage with the SIMEOX device. Sputum will be collected during the session. | Device: SIMEOX + Autogenic drainage<br>* SIMEOX is a device generating a succession of gentle depression at the mouth during the expiratory phase associated with autogenic drainage.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of sputum secretion | Total wet weight and dry weight of sputum collected in the 24-h following each intervention will be quantified. | 30-min | 
| Mucus viscoelasticity | Change in rheological properties of the sputum before and after each intervention will be analyzed using a rheometer. We will use the Rheomuco (Rheonova) reometer to obtain the differences in elasticity (G'), viscosity (G')' and elastic modulus ratio (tanδ) of the secretions collected before and after each intervention. | 30-min | 
| Subjective feeling of ease to expectorate | A Visual Analogue Scale (VAS) will be used to measure subjective feeling of ease of expectoration during each intervention. The visual analogue scale (VAS) is a semi-objective rating system that will be used to quantify the subjective feeling of ease to expectorate. The VAS is represented by a horizontal line marked 0 to 10, where 0 indicates very easy to expectorate and 10 indicates not easy to expectorate at all. The lower the score, the easier it is to expectorate. | 3-min |