Long-term Evaluation of the SIMEOX Device at Home in Non-cystic Fibrosis Bronchiectasis
Condition(s) studied
Investigational drug(s) / intervention(s)
SIMEOX: Use of the CE-marked SIMEOX medical device. No specific limitation of the number of use but recommendation to use it daily (and more if needed).
Remote Physiotherapy: Remote Physiotherapy with physiotherapists, once a month for the first 3 months and once every 3 months after
Study summary
Bronchiectasis is a chronic lung disease of multiple aetiologies characterised by permanent dilatation of the calibre of a territory of the bronchial tree with impaired mucociliary clearance. This alteration causes mucus retention, leading to infections and chronic bronchial inflammation. Respiratory physiotherapy is one of the cornerstones of the management of these patients, in particular to facilitate bronchial drainage. In patients with abundant bronchial secretions, it is recommended that bronchial drainage sessions be carried out on a daily or more frequent basis, which represents a very substantial burden in terms of care. In addition, access to respiratory physiotherapy is not always easy for patients due to geographical or time constraints or the availability of professionals. Moreover, few professionals are trained in this specific care for chronic lung diseases.
SIMEOX (Physio-Assist, France) is an innovative medical device (CE medical mark) for draining the bronchial tree. By means of a mouthpiece, this device generates a succession of very short intermittent negative air pressure pulses which disseminate a pneumatic vibratory signal in the patient's bronchial tree, modifying the rheological properties of the mucus, facilitating the mobilisation of secretions and assisting their transport towards the upper airways.
A recent pilot study demonstrated that the use of SIMEOX independently by the patient at home for 3 months, combined with remote Physiotherapy (1 session/2 weeks), provided a very satisfactory bronchial drainage solution for patients (satisfaction assessed at 9/10 by visual analogue scale), with an improvement in their quality of life and very good compliance with the device (median of 4.7 sessions/week).
This bronchial drainage strategy requires a long-term assessment.
Hypothesis: the use of SIMEOX independently by the patient at home could improve long-term quality of life and reduce the rate of pulmonary exacerbations in non-cystic fibrosis (non-CF) patients with bronchiectasis (bronchial dilatation) in comparison to Standard of Care (SoC).
Eligibility
Primary outcome measure(s)
- Quality of life SGRQ at 6 months — Change from baseline at 6 months
The change in the St George's Hospital Respiratory Questionnaire total quality of life score from baseline (inclusion) at 6 months of treatment, adjusted on the baseline score, with a comparison between the SIMEOX-treated group and the control group. - The annual rate of pulmonary exacerbations — Over the duration of the study (24 months in average)
The annual rate of pulmonary exacerbations observed per patient per year compared between the SIMEOX-treated group and the control group over the duration of the study (24 months in average).
Trial sites (57)
| Facility | City | Region | Status |
|---|---|---|---|
| CH Abbeville | Abbeville | France | Recruiting |
| CH Aix en Provence | Aix-en-Provence | France | Recruiting |
| CH Albi | Albi | France | Recruiting |
| Clinique Victor Pauchet | Amiens | France | Recruiting |
| CHU Amiens Picardie | Amiens | France | Recruiting |
| CHU Angers | Angers | France | Recruiting |
| CH Annecy | Annecy | France | Recruiting |
| Clinique Aressy | Aressy | France | Recruiting |
| CHRU Brest | Brest | France | Recruiting |
| CH Cotentin | Cherbourg | France | Recruiting |
| CH Compiègne-Noyon | Compiègne | France | Recruiting |
| CH Alpes-Léman | Contamine-sur-Arve | France | Recruiting |
| CHI Créteil | Créteil | France | Recruiting |
| CFR Dieulefit | Dieulefit | France | Recruiting |
| CHU Grenoble-Alpes | Grenoble | France | Recruiting |
| HCL - centre de Hyères | Hyères | France | Recruiting |
| Groupe Hospitalier La Rochelle - Ré-Aunis | La Rochelle | France | Suspended |
| Hôpital Bicêtre (AP-HP) | Le Kremlin-Bicêtre | France | Withdrawn |
| CH Le Puy-en-Velay | Le Puy-en-Velay | France | Recruiting |
| CH Libourne | Libourne | France | Recruiting |
| CHU Limoges | Limoges | France | Recruiting |
| HCL- Hôpital Croix-Rousse | Lyon | France | Recruiting |
| Hôpital Européen de Marseille | Marseille | France | Recruiting |
| Groupe Hospitalier du Havre | Montivilliers | France | Withdrawn |
| Montpellier Hospital Center | Montpellier | France | Recruiting |
| CHU Nice | Nice | France | Recruiting |
| CHU Nîmes | Nîmes | France | Recruiting |
| Hôpital Cochin (AP-HP) | Paris | France | Recruiting |
| CH Pau | Pau | France | Recruiting |
| CH Perpignan | Perpignan | France | Not Yet Recruiting |
| CHU Poitiers | Poitiers | France | Recruiting |
| CHU Reims | Reims | France | Recruiting |
| CHU Rennes | Rennes | France | Recruiting |
| Fondation Ildys | Roscoff | France | Recruiting |
| CHU Rouen | Rouen | France | Withdrawn |
| CH St Quentin | Saint-Quentin | France | Recruiting |
| Hôpital Foch | Suresnes | France | Recruiting |
| CH Tarbes Lourdes | Tarbes | France | Recruiting |
| CHU Toulouse | Toulouse | France | Recruiting |
| CH Troyes | Troyes | France | Recruiting |
+ 17 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06487273 on ClinicalTrials.gov ↗ ← All trials in France