CPAP and NIV Interfaces : Side-effects in Home Care Patients (NCT03013283) | Clinical Trial Compass
CompletedNot Applicable
CPAP and NIV Interfaces : Side-effects in Home Care Patients
France6,000 participantsStarted 2017-02-07
Plain-language summary
Home ventilation techniques consist mainly of two techniques, Continuous Positive Airway Pressure or CPAP and Non Invasive Ventilation or NIV. Whether for CPAP or NIV, pressures are delivered to the patient via an interface.
The efficacy of CPAP and NIV is conditioned in part by the observance of the patients to the device. Because the comfort and degree of satisfaction of the patients to its interface is a key factor of the observance, side-effects and satisfaction of patients need to be continuously evaluated with available interfaces for CPAP and NIV treated patients.
The purpose of the research is the evaluation of interface side-effects and the degree of satisfaction of home care patients treated for at least three months with CPAP or NIV.
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:
* Written informed consent
* Age more than 18 years (inclusive)
* Patient treated with CPAP or NIV for at least three months,and eligible for care and for the reimbursement by the French Social Security rules.
* Patient presents during a scheduled home visit of the technician for the continuation of CPAP or NIV treatment according to the French Social Security rules.
Exclusion Criteria:
* Pregnancy, intention of being pregnant, breastfeeding.
* Inability to understand the nature and aims of the study or to communicate with the investigator
* Simultaneous participation in another trial with an exclusion clause to participate to an other trial.
* No affiliation to the French social security
* Loss of personal capacity resulting in state protection
* Deprivation of liberty by judicial or administrative decision
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
Interface side effects and degree of satisfaction of the patients