Long-term Evaluation of the SIMEOX Device at Home in Non-... | NCT06487273

Status Module

Name	Class
Icadom	INDUSTRY
Clinact	OTHER

Description Module

Brief 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).

Label	Type	Description	Intervention Names
Control	Other	Remote Physiotherapy + standard of care	Other: Remote Physiotherapy
SIMEOX	Experimental	SIMEOX device combined with Remote Physiotherapy + standard of care	Device: SIMEOX Other: Remote Physiotherapy

Name	Type	Description	Arm Group Labels	Other Names
SIMEOX	Device	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).	SIMEOX

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of life SGRQ 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.	Change from baseline at 6 months
The annual rate of pulmonary exacerbations	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).	Over the duration of the study (24 months in average)

Secondary Outcomes

Measure	Description	Time Frame
Quality of life SGRQ at 12 months	The change in total quality of life score measured by the St George's Respiratory Questionnaire from baseline at 12 months of treatment, adjusted for the baseline score, will be compared between the SIMEOX-treated group and the control group.	Change from baseline at 12 months

Eligibility Module

Eligibility Criteria

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
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 (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

Name	Role	Phone	Extension	Email
Pauline Périnet-Marquet	Contact	+33 7 63 23 66 15		p.perinet-marquet@icadom.com
Laurent Morin	Contact	+33 6 03 27 30 12		laurent.morin@inogen.net

Facility	Status	City	State	ZIP	Country	Contacts
CH Abbeville	Recruiting	Abbeville			France
CH Aix en Provence