Installation of Non-invasive Ventilation at Home Using Telemedicine : a Pilot Study on Feasibilit… (NCT02103790) | Clinical Trial Compass
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Installation of Non-invasive Ventilation at Home Using Telemedicine : a Pilot Study on Feasibility and Impact on Ventilation Compliance
France20 participantsStarted 2015-01
Plain-language summary
Neuromuscular diseases are frequently associated with respiratory failure, which requires Non Invasive Ventilation (NIV). Currently, the NIV installation is done during an hospitalization of several days. This hospitalization is problematic because of availability of beds, logistical difficulties for the patient and estrangement from the usual environment.
For this reasons, the NIV installation at home could be an interesting alternative for both the patient and the medical staff.
The aim of this pilot study is to test the feasibility of NIV installation at home, using telemedicine as a remote monitoring tool, and to assess its impact on the ventilation compliance.
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:
* Man or Women aged over 18 years
* Neuromuscular disease or kyphoscoliosis
* At least one sign among : dyspnea, orthopnea, daytime sleepiness, cephalalgia, asthenia
* At least one sign among : hypercapnia \> 45 mmHg, desaturation time \< 88%, night desaturation time \> 5 min, Vital Capacity \< 60% or Pimax \< 60 cm H2O.
Exclusion Criteria:
* Mechanic ventilation refusal
* Patient living alone
* Acute respiratory failure
* Patient who need a third party for the ventilation installation
* Severe respiratory limitation
* Home oxygen
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
Number of required days to obtain a 4-hours-night ventilation
Timeframe: 5 days
Trial details
NCT IDNCT02103790
SponsorCentre d'Investigation Clinique et Technologique 805