Home Airway Clearance in CF Patients (HomeCareSIMEOX)

PhysioAssist

Status

Enrolling

Conditions

Pulmonary Cystic Fibrosis

Treatments

Device: SIMEOX

Study type

Interventional

Funder types

Industry

Identifiers

NCT04096664

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, post-care, 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

160 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient diagnosed with Cystic fibrosis
Stabilization of the disease, defined by an at least 4 weeks period since the end of an exacerbation, stabilization will be let to investigator's judgment.
Age >12
Requiring at least 1 bronchial clearing session each week (regardless of the technique)
Patient (or patient's legal representative if applicable), capable to read and understand the procedure, and capable to express consent for the study protocol.

Exclusion criteria

Severe pneumothorax or hemoptysis (more than 30ml per 24 hours) within 6 weeks before the inclusion day.
Patient placed on a transplant waiting list
Any contraindication to an instrumental bronchial clearance technique
Patients already own and use SIMEOX at home
Unavailable patient or patient wishing to move to a different region within three months after inclusion.
Patient currently participating or having participated to another interventional clinical research within a month prior inclusion date, that may impact the study, this impact is left to the investigator's judgment.
Persons referred by the French Public Health Code to Articles L1121-5 to L1121-8 (includes all protected persons: pregnant women (confirmed by measurement of the serum human chorionic gonadotropin level for any woman wishing to enter the protocol and under childbearing age < 60), parturient woman, breastfeeding mother, everyone deprived of his liberty by judicial or administrative decision, everyone subject to a legal protection measure.
Initiation of treatment with a CFTR modulator within the last 3 months