Ancillary Home Airway Clearance in CF Patients ( HomeCareSIMEOX )

PhysioAssist

Status: Completed

Conditions: Pulmonary Cystic Fibrosis

Treatments: Device: SIMEOX

Study type: Interventional

Funder types: Industry

Identifiers

NCT04095078

Ancillary Home-Care SIMEOX

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

SIMEOX

Experimental group

Description:

Use the device for 3 months in addition to usual care

Treatment:

Device: SIMEOX

Control

No Intervention group

Description:

Usual care