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RECRUITING
NCT06487273
NA

Long-term Evaluation of the SIMEOX Device at Home in Non-cystic Fibrosis Bronchiectasis

Sponsor: Physio-Assist

View on ClinicalTrials.gov

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

Interventions

DEVICE

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).

OTHER

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