An interventional study of SIMEOX in Pulmonary Cystic Fibrosis, sponsored by Physio-Assist. Completed at 5 sites in France. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2022-01-04.
Sponsored by Physio-Assist · Not applicable, Interventional, and Treatment
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.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's enrollment of 56 is above the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →Physio-Assist is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Use the device for 3 months in addition to usual care
Device: SIMEOX
Usual care
Use without obligation, in autonomous and at home of the bronchial clearance device: SIMEOX
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
Plan to share: No
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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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