Initiation of Polygraphy for Neuromuscular Disease Patients Under Non-invasive Mechanical Ventilation

Assistance Publique - Hôpitaux de Paris1 site in 1 country25 target enrollmentMarch 8, 2024

ConditionsNeuromuscular Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Neuromuscular Diseases
Sponsor: Assistance Publique - Hôpitaux de Paris
Enrollment: 25
Locations: 1
Primary Endpoint: Gradation of quality of recorded signals at home
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

March 8, 2024

End Date

March 1, 2026

Last Updated

5 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Assistance Publique - Hôpitaux de Paris

Responsible Party

Sponsor

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).