RecruitingNot Applicable

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

France622 participantsStarted 2025-02-03

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female aged over 18 years * 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: * Patients using one of the following motorised mechanical bronchial drainage devices at home at the time of inclusion: * 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 * Cysti…

What they're measuring

Quality of life SGRQ at 6 months

Timeframe: Change from baseline at 6 months

The annual rate of pulmonary exacerbations

Timeframe: Over the duration of the study (24 months in average)

Trial details

NCT IDNCT06487273

SponsorPhysio-Assist

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Pauline Périnet-Marquet

+33 7 63 23 66 15 p.perinet-marquet@icadom.com