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Using a device at home to help clear airways in cystic fibrosis patients

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

Not applicable Interventional Physio-Assist · NCT04096664

This study is testing whether using the SIMEOX® device at home can help people with cystic fibrosis clear mucus from their airways better than just using it in a clinic.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment160 (estimated)
Ages12 Years and up
SexAll
SponsorPhysio-Assist Industry-sponsored
Locations20 sites (Amiens and 19 other locations)
Trial IDNCT04096664 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and acceptability of the SIMEOX® device for bronchial clearance in patients with cystic fibrosis when used at home. The device works by altering the properties of mucus to facilitate its movement and clearance from the airways. Patients aged over 12, who have stabilized their condition, will use the device independently to manage their bronchial health. The study aims to determine if long-term home use can improve patient outcomes compared to traditional short-term use in clinical settings.

Who should consider this trial

Good fit: Ideal candidates are patients aged over 12 with a diagnosis of cystic fibrosis who have stabilized their condition and require regular bronchial clearance.

Not a fit: Patients with severe pneumothorax, those on a transplant waiting list, or those already using the SIMEOX device at home may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the quality of life for cystic fibrosis patients by providing an effective home-based solution for airway clearance.

How similar studies have performed: While the use of devices for bronchial clearance is established, the specific application of SIMEOX for long-term home use represents a novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Amiens and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pulmonary Cystic Fibrosisbronchial clearancecystic fibrosis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.