Simeox Therapy at Home Versus Standard of Care in NCFB Patients With CMH (NCT06237348) | Clinical Trial Compass
CompletedNot Applicable
Simeox Therapy at Home Versus Standard of Care in NCFB Patients With CMH
Poland50 participantsStarted 2023-10-15
Plain-language summary
This pilot RCT will assess benefits of Simeox technology on lung function, respiratory symptoms, health-related quality of life, subjective efficiency, device adherence at home, Patient satisfaction, tolerance, safety, and telecare feasibility.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient with confirmed diagnosis of bronchiectasis confirmed by High Resolution Computed Tomography (HRCT): idiopathic, post-infective, systemic disease, ABPA, asthma, COPD, PCD
* Overproduction of mucus (ie: estimated bronchorrhea \>10mL/day).
* Pulmonary exacerbation (in- or outpatients)
* Age \> 18 years old
* Patient able to understand the study and to perform the 2-month follow up visit
Exclusion Criteria:
* Pneumothorax/pneumo-mediastinum in the six months prior hospitalization
* Recent episode of severe haemoptysis
* Unstable severe cardiac disease or hemodynamic instability
* Cystic fibrosis or COPD as dominant diagnosis
* Patient on lung transplant list
* Severe lung injuries
* Recent lung surgery
* Inhalation support (continuous ventilatory support)
* Tracheostomy
* Uncontrolled GERD
* Any contraindication to an instrumental bronchial clearance technique (up to the investigator)
* Inability to perform PFT or 6MWT
* Patient not available or wishing to move to a different region within 2 months of inclusion
* Patient considered by the investigator to be physically or mentally inapt to use the device and/or to perform the study procedures.
* Patient currently participating or having participated within one month prior to inclusion in a clinical intervention research trial that may impact the study, the impact of which is up to the investigator
What they're measuring
1
To describe the evolution in Self-reported home adherence from baseline (hospital discharge) during follow-up