What is the SIMEOX device studying for non-cystic fibrosis bronchiectasis?

The SIMEOX device is being studied to see if using it at home with remote physiotherapy can improve quality of life and reduce lung flare-ups in people with non-cystic fibrosis bronchiectasis. This research, led by Physio-Assist, aims to assess long-term benefits compared with enhanced standard care.

Who may be eligible for this non-cystic fibrosis bronchiectasis clinical trial?

Adults aged 18 or older with a confirmed diagnosis of non-cystic fibrosis bronchiectasis who have regular sputum production and are clinically stable may be eligible. Participants should have experienced recent lung flare-ups needing treatment or hospitalization. This study welcomes all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this non-cystic fibrosis bronchiectasis clinical trial?

Study-related care, including the SIMEOX device and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered during participation.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID06487273

Evaluation of the Impact of SIMEOX Airway Clearance Device at Home Combined With Remote Physiotherapy on Quality of Life and Lung Flare-ups in Non-cystic Fibrosis Bronchiectasis

Led by Physio-Assist · Updated on 2026-06-08

622

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Bronchiectasis is a chronic lung condition marked by permanent widening of parts of the airway, causing mucus buildup, infections, and ongoing lung inflammation. This study evaluates whether using the SIMEOX device at home, combined with remote physiotherapy, can improve quality of life and reduce lung flare-ups in adults with non-cystic fibrosis bronchiectasis compared to enhanced standard care. The study is led by Physio-Assist and focuses on long-term effects over two years. Participants are randomly assigned to one of two groups one receiving standard care plus remote physiotherapy, and the other using the SIMEOX device along with remote physiotherapy and standard care. The SIMEOX device helps clear mucus by delivering short negative air pulses through a mouthpiece. Remote physiotherapy sessions occur once a month for the first three months, then every three months thereafter. Use of the SIMEOX device is recommended daily or more often if needed. During the 24-month study, participants will be assessed at multiple points for changes in respiratory quality of life using questionnaires like the SGRQ, as well as lung function tests and tracking the frequency of lung exacerbations and hospitalizations. Researchers will monitor compliance with the device, adverse events, and other health outcomes. This comprehensive follow-up aims to understand the devices impact on patient wellbeing and lung health over the long term.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Male or female aged over 18 years
Diagnosis of non-cystic fibrosis bronchiectasis confirmed by computed tomography (CT)
Regular and chronic sputum production
Clinically stable at inclusion, with at least 4 weeks since last exacerbation and no change in treatment for 4 weeks
At least two pulmonary exacerbations in the past 12 months requiring treatment changes, or at least one exacerbation requiring hospitalization
Physically and psychologically able to use the device and follow study procedures
Covered by a social security system when applicable

You will not qualify if you...

Current use of motorized mechanical bronchial drainage devices at home such as SIMEOX, high-frequency chest wall oscillation devices, or intrapulmonary percussion ventilation
Use of a powered mechanical cough aid at home for less than one year
Diagnosis of cystic fibrosis
Predominant diagnosis of COPD, asthma, traction bronchiectasis, bronchiectasis from focal lesions, sarcoidosis, or active allergic bronchopulmonary aspergillosis
Active smoking
Suspected or unstable immune deficiency
Risk of stopping long-term immunosuppressive treatment during the study
Unstable cardiovascular conditions or haemodynamic instability
Uncontrolled gastro-oesophageal reflux
Recent acute pneumothorax or increased risk of pneumothorax
Inability to cough vigorously and independently
Significant haemoptysis within 6 weeks prior to inclusion
Use of endotracheal or tracheostomy tubes or daytime ventilation over 16 hours
Neuromuscular disease with respiratory muscle weakness
Recent cardiothoracic or oesophageal surgery within 3 months
Severe acute lung injury or barotrauma within 3 months
Difficulty evacuating secretions due to muscle weakness
Risk of airway aspiration
Inspiratory muscle weakness limiting breathing work
Severe restrictive lung disease
Bullous emphysema
Participation in other interventional clinical studies within the past month or during the study
Plans to move to a region without study availability before study end
Vulnerable populations including pregnant or breastfeeding women, those planning pregnancy, persons deprived of liberty, or under legal protection measures

Research Team

Pauline Périnet-Marquet

Laurent Morin

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