Ancillary Home Airway Clearance in CF Patients ( HomeCareSIMEOX )

Not Applicable

Completed

• Conditions: Pulmonary Cystic Fibrosis
• Interventions: Device: SIMEOX

• Registration Number: NCT04095078
• Lead Sponsor: Physio-Assist

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-17
• Study First Submitted QC: 2019-09-17
• Study First Posted: 2019-09-19
• Study Start: 2020-03-10
• Primary Completion: 2021-09-15
• Study Completion: 2021-12-15
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-03
• Last Update Posted: 2022-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SIMEOX	SIMEOX	Use the device for 3 months in addition to usual care

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Grenoble University Hospital : pneumo-pediatric department; 🇫🇷 Grenoble, France

Grenoble University-Affiliated Hospital : Pneumology department; 🇫🇷 Grenoble, France

Nice University-Affiliated Hospital : Pneumology department; 🇫🇷 Nice, France

Nice University-Affiliated Hospital : Pneumo-pediatric department; 🇫🇷 Nice, France

Montpellier Hospital Center; 🇫🇷 Montpellier, France