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 range
18 Years
Sex
ALL
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:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To describe the evolution in Self-reported home adherence from baseline (hospital discharge) during follow-up