Regular bronchial clearance is essential in patients with cystic fibrosis for their bronchial health. SIMEOX® (Physio-Assist, Aix en Provence, France) is an innovative medical device for the drainage of the bronchial tree. By changing the rheological properties of mucus, SIMEOX® helps to mobilize secretions and assists their transport to the upper airways. This technology is based on fundamental research on bronchial mucus rheology. At the present time, SIMEOX® device is mainly used over a short period at the time or after an exacerbation in healthcare structures (hospitals, physiotherapy practices, postcare, and rehabilitation units, etc…). The clinical effects observed in the short term encourages long-term autonomous use by the patients themselves. The overall objective of this study is to evaluate the efficiency and acceptability of SIMEOX® used at home by the patient himself for bronchial clearance in patients with cystic fibrosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Use without obligation, in autonomous and at home of the bronchial clearance device: SIMEOX
Grenoble University Hospital : pneumo-pediatric department
Grenoble, France
Grenoble University-Affiliated Hospital : Pneumology department
Grenoble, France
Montpellier Hospital Center
Montpellier, France
Nice University-Affiliated Hospital : Pneumology department
Nice, France
Nice University-Affiliated Hospital : Pneumo-pediatric department
Nice, France
Pulmonary static hyperinflation assessed by residual volume
Relative variation in Pulmonary residual volume in the SIMEOX® treated group versus control group.
Time frame: Change from baseline at 3 months
Use assessed by the duration of use of SIMEOX® device
Assess the duration of uses of the device SIMEOX by the patient in the SIMEOX® treated group to assess the use by patient of the device.
Time frame: During 3 months of use
Inspiratory capacity
Relative variation of Inspiratory capacity in liter in the SIMEOX® treated group versus control group
Time frame: Change from baseline at 3 months
Residual functional capacity (RFC)
Relative variation of Residual functional capacity (RFC) in liter in the SIMEOX® treated group versus control group
Time frame: Change from baseline at 3 months
Total lung capacity (TLC)
Relative variation of Total lung capacity (TLC) in liter in the SIMEOX® treated group versus control group
Time frame: Change from baseline at 3 months
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