Long-term Evaluation of the SIMEOX Device at Home in Non-cystic Fibrosis Bronchiectasis
NCT ID: NCT06487273
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
622 participants
INTERVENTIONAL
2025-02-03
2027-12-31
Brief Summary
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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).
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Detailed Description
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* To compare the effect of SIMEOX, combined with remote Physiotherapy, with enhanced SoC (SoC + Remote Physiotherapy), on the quality of life related to the respiratory problems of patients at mid term.
* To compare the effect of SIMEOX, combined with remote Physiotherapy with enhanced SoC (SoC + Remote Physiotherapy) on the rate of respiratory exacerbations at long term.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
2 groups : comparison of SIMEOX + remote Physiotherapy + standard of care versus remote Physiotherapy + standard of care
TREATMENT
SINGLE
A blinded adjudication committee will review the outcome for one primary endpoint (exacerbations).
Study Groups
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Control
Remote Physiotherapy + standard of care
Remote Physiotherapy
Remote Physiotherapy with physiotherapists, once a month for the first 3 months and once every 3 months after
SIMEOX
SIMEOX device combined with Remote Physiotherapy + standard of care
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Predominant diagnosis of Non CF bronchiectasis disease, excluding cystic fibrosis, confirmed by computed tomography (CT).
* Regular and chronic sputum production
* Clinically stable at inclusion
* Defined by a delay of at least 4 weeks since the end of the last exacerbation according to the European consensus (Hill, European Respiratory Journal, 2017)
* No change in disease-modifying treatment for 4 weeks.
* Having had at least two pulmonary exacerbations in the 12 months prior to inclusion and having required a change in specific treatment for these exacerbations.
Or Having had at least one pulmonary exacerbation in the 12 months prior to inclusion requiring hospitalisation.
* Considered by the investigator to be physically and psychologically able to use the device and carry out the procedures under study.
* Patient covered by a social security system, when applicable in the concerned country
Exclusion Criteria
* SIMEOX,
* an extra-thoracic high-frequency chest wall oscillation device (HFCWO) (The Vest,...)
* intrapulmonary percussion ventilation (IPV)
* Patients who have been using a powered mechanical cough aid at home for less than a year at the time of inclusion:
* a mechanical in-exsufflator (MI E) such as the Cough Assist
* a pressure reducer such as the Alpha300
* Cystic fibrosis
* Predominant diagnosis of Chronic obstructive pulmonary disease (COPD) or asthma, traction bronchiectasis, bronchiectasis resulting from focal endobronchial lesion, sarcoidosis or active allergic bronchopulmonary aspergillosis.
* Active smoking
* Suspected (but undiagnosed) or unstabilised immune deficiency (at investigator's discretion)
* In the case of long-term immunosuppressive treatment, risk of discontinuation of this treatment during the study.
* Unstable cardiovascular pathologies (acute coronary syndrome, unstable angina pectoris, uncontrolled rhythm disorders, unstable heart failure)
* Haemodynamic instability
* Uncontrolled gastro-oesophageal reflux (persistence of symptoms despite treatment), at investigator's discretion.
* Acute pneumothorax or increased susceptibility to pneumothorax/pneumomediastinum
* Inability to cough vigorously and independently, at investigator's discretion
* Had a significant episode of haemoptysis in the 6 weeks prior to inclusion, at the discretion of the investigator
* Patient using an endotracheal tube, tracheostomy tube or daytime ventilation \>16h with a mask
* Patients with neuromuscular disease and respiratory muscle weakness, at the discretion of the investigator
* Recent cardiothoracic surgery, including oesophageal surgery within 3 months of inclusion
* Severe acute lung injury or barotrauma within 3 months of inclusion
* Difficulty in evacuating secretions from the upper airways due to weakness of the respiratory muscles, or of the oropharyngeal or buccal musculature, at the discretion of the investigator
* Risk of airway aspiration, e.g. from tube feeding or recent meals, at investigator's discretion
* Inspiratory muscle weakness with inability to tolerate increased work of breathing, at investigator's discretion
* Severe restrictive disease (Forced Vital Capacity \< 60% or Total Lung Capacity \< 60% with complete plethysmography)
* Bullous emphysema
* Participation in other interventional clinical study in the month prior to inclusion or during the study period
* Patient unavailable or wishing to move to a region where the protocol is not present before the end of their participation
* Vulnerable people:
* pregnant women (verified by a urine or blood human chorionic gonadotropin (HCG) test for all women wishing to participate in the protocol and of childbearing age, without contraception), breastfeeding mothers or women planning to become pregnant during the period of participation in the clinical investigation
* a person deprived of liberty by judicial or administrative decision
* a person subject to a legal protection measure
18 Years
ALL
No
Sponsors
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Icadom
INDUSTRY
Clinact
OTHER
Physio-Assist
INDUSTRY
Responsible Party
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Principal Investigators
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Sylvie Leroy, MD
Role: PRINCIPAL_INVESTIGATOR
CHU NICE
Locations
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Hôpital Européen de Marseille
Marseille, , France
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
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
CHU La Réunion Félix Guyon
Saint-Denis, , Reunion
CHU La Réunion Sud
Saint-Pierre, , Reunion
Countries
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Central Contacts
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References
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Hamidfar R, Murris-Espin M, Mahot M, Abouly R, Gauchez H, Jacques S, Joffray E, Arnol N, Morin L, Leroy S, Borel JC. Feasibility of home initiation of an airway clearance device (SIMEOX) by telecare in people with non-cystic fibrosis bronchiectasis: a pilot study. BMJ Open Respir Res. 2023 Jul;10(1):e001722. doi: 10.1136/bmjresp-2023-001722.
Other Identifiers
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2023-A01095-40
Identifier Type: -
Identifier Source: org_study_id
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