Efficiency and Acceptability of SIMEOX® Used Autonomously at Home for Bronchial Clearance in Patients With Cystic Fibrosis: Prospective, Randomized Controlled Study (HomeCareSIMEOX)

  • STATUS
    Recruiting
  • End date
    Jun 20, 2024
  • participants needed
    224
  • sponsor
    Physio-Assist
Updated on 20 October 2022

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, 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.

Details
Condition Pulmonary Cystic Fibrosis
Treatment SIMEOX
Clinical Study IdentifierNCT04096664
SponsorPhysio-Assist
Last Modified on20 October 2022

Eligibility

Yes No Not Sure

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 >14
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
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