Polygraphy at Home for Neuromuscular Patients Under Non-invasive Mechanical Ventilation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patient refusal;

Patient under guardianship;

Patient under AME scheme;

Patients living more than 40 km from reference center;

Trial population

Chronic respiratory failure due to neuromuscular diseases under non-invasive mechanical ventilation

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Polygraphy diagnostic at home

    Procedure/Surgery

    Polygraphy diagnostic at home for patients under non-invasive mechanical ventilation.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Initiation a non-invasive ventilation at night1 intervention

Trial outcomes

Primary outcomes

1

Gradation of quality of recorded signals at home

Expressed in number of readable signals for which the readability will be expressed in % of record time.

Time frame
at day 1

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Association Française contre les Myopathies (AFM), Paris

Collaborator