Polygraphy at Home for Neuromuscular Patients Under Non-invasive Mechanical Ventilation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Polygraphy diagnostic at home.
- Who it may be relevant to
- Registry conditions: Neuromuscular Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Initiation of Polygraphy for Neuromuscular Disease Patients Under Non-invasive Mechanical Ventilation
Overview
The primary objective of the study is to evaluate the feasibility, the quality and the utility of a polygraphic control at home in order to appreciate the efficacy of the night time non-invasive ventilation (allowing to optimize the ventilator settings when the results are not satisfactory).
Interventions
- Procedure Polygraphy diagnostic at home
Polygraphy diagnostic at home for patients under non-invasive mechanical ventilation.
Primary outcome measures
- Gradation of quality of recorded signals at home [Time frame: at day 1]
Eligibility criteria
Inclusion criteria
- Patient ≥ 18 years;
- Patient with chronic respiratory insufficiency has just been posed non-invasive ventilation (NIV) in the hospital, according to the latest international recommendations ;
- Affiliation to the social security scheme;
- Patient has signed the informed consent form to participate to the study.
Exclusion criteria
- Patient refusal;
- Patient under guardianship;
- Patient under AME scheme;
- Patients living more than 40 km from reference center;
- Patient depending on mechanical ventilation (more than 6 hours daily);
- Rapidly or reversible evolutive neuro-myopathy (Amyotrophic lateral sclerosis, Guillain Barré syndrome, myasthenia).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
France · 1 center
- Department of physiology and functional explorations - Raymond Poincaré Hospital - APHP — Garches
Identifiers
NCT: NCT05785637 · APHP230176 · 2022-A01925-38