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Long-term Evaluation of the SIMEOX Device at Home in Non-cystic Fibrosis Bronchiectasis
Sponsor: Physio-Assist
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).
Official title: Evaluation of the Impact of SIMEOX Airway Clearance Medical Device at Home, Combined With Remote Physiotherapy, on Quality of Life and Pulmonary Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis, Compared With Enhanced Standard of Care
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
622
Start Date
2025-02-03
Completion Date
2027-12
Last Updated
2026-02-17
Healthy Volunteers
No
Conditions
Interventions
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
Locations (57)
CH Abbeville
Abbeville, France
CH Aix en Provence
Aix-en-Provence, France
CH Albi
Albi, France
Clinique Victor Pauchet
Amiens, France
CHU Amiens Picardie
Amiens, France
CHU Angers
Angers, France
CH Annecy
Annecy, France
Clinique Aressy
Aressy, France
CHRU Brest
Brest, France
CH Cotentin
Cherbourg, France
CH Compiègne-Noyon
Compiègne, France
CH Alpes-Léman
Contamine-sur-Arve, France
CHI Créteil
Créteil, France
CFR Dieulefit
Dieulefit, France
CHU Grenoble-Alpes
Grenoble, France
HCL - centre de Hyères
Hyères, France
Groupe Hospitalier La Rochelle - Ré-Aunis
La Rochelle, France
Hôpital Bicêtre (AP-HP)
Le Kremlin-Bicêtre, France
CH Le Puy-en-Velay
Le Puy-en-Velay, France
CH Libourne
Libourne, France
CHU Limoges
Limoges, France
HCL- Hôpital Croix-Rousse
Lyon, France
Hôpital Européen de Marseille
Marseille, France
Groupe Hospitalier du Havre
Montivilliers, France
Montpellier Hospital Center
Montpellier, France
CHU Nice
Nice, France
CHU Nîmes
Nîmes, France
Hôpital Cochin (AP-HP)
Paris, France
CH Pau
Pau, France
CH Perpignan
Perpignan, France
CHU Poitiers
Poitiers, France
CHU Reims
Reims, France
CHU Rennes
Rennes, France
Fondation Ildys
Roscoff, France
CHU Rouen
Rouen, France
CH St Quentin
Saint-Quentin, France
Hôpital Foch
Suresnes, France
CH Tarbes Lourdes
Tarbes, France
CHU Toulouse
Toulouse, France
CH Troyes
Troyes, France
CH Bretagne Atlantique
Vannes, France
Medizinische Klinik V University hospital
Aachen, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Germany
LMU Klinikum
München, Germany
Szpital Uniwersytecki w Krakowie
Krakow, Poland
Uniwersytet Medyczny w Łodzi Nr 1 im. Norberta Barlickiego
Lodz, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Poland
Centro Clínico Académico de Braga (2CA-Braga) ULS de Braga
Braga, Portugal
Hospital Senhora de Oliveira Guimarães ULS Alto Ave
Creixomil, Portugal
Instituto CUF
Porto, Portugal
CHU La Réunion Félix Guyon
Saint-Denis, Reunion
CHU La Réunion Sud
Saint-Pierre, Reunion
Royal Victoria Hospital, Belfast Health and Social Care Trust
Belfast, United Kingdom
Heartland Hospital, University Hospitals Birmingham, NHS Foundation Trust
Birmingham, United Kingdom
NHS Lothian
Edinburgh, United Kingdom
Wythenshawe Hospital, Manchester University, NHS Foundation Trust
Manchester, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom