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

A

Assistance Publique - Hôpitaux de Paris

Status

Enrolling

Conditions

Neuromuscular Diseases

Treatments

Procedure: Polygraphy diagnostic at home

Study type

Observational

Funder types

Other

Identifiers

NCT05785637
APHP230176
2022-A01925-38 (Registry Identifier)

Details and patient eligibility

About

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).

Enrollment

25 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

25 participants in 1 patient group

Initiation a non-invasive ventilation at night
Description:
Neuromuscular patients with chronic respiratory failure who initiate a non-invasive ventilation at night.
Treatment:
Procedure: Polygraphy diagnostic at home

Trial contacts and locations

1

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Central trial contact

Frédéric Lofaso, MD, PhD; Hélène Prigent, MD, PhD

Data sourced from clinicaltrials.gov

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