Pulmonary Cystic Fibrosis
Conditions
Keywords
bronchial clearance, cystic fibrosis
Brief summary
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.
Interventions
DEVICESIMEOX
Use without obligation, in autonomous and at home of the bronchial clearance device: SIMEOX
Sponsors
Icadom
Physio-Assist
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, randomized, controlled, multicenter trial
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* one of the 56 first patients of HOME-CARE SIMEOX study * same criteria as HOME-CARE SIMEOX study
Exclusion criteria
* same criteria as HOME-CARE SIMEOX study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary static hyperinflation assessed by residual volume | Change from baseline at 3 months | Relative variation in Pulmonary residual volume in the SIMEOX® treated group versus control group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use assessed by the duration of use of SIMEOX® device | During 3 months of use | 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. |
| Inspiratory capacity | Change from baseline at 3 months | Relative variation of Inspiratory capacity in liter in the SIMEOX® treated group versus control group |
| Residual functional capacity (RFC) | Change from baseline at 3 months | Relative variation of Residual functional capacity (RFC) in liter in the SIMEOX® treated group versus control group |
| Total lung capacity (TLC) | Change from baseline at 3 months | Relative variation of Total lung capacity (TLC) in liter in the SIMEOX® treated group versus control group |
Countries
France
Outcome results
None listed