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NCT Number: NCT05785637

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

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).

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of physiology and functional explorations - Raymond Poincaré Hospital - APHP

Garches, 92380, France

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Polygraphy diagnostic at home

Procedure

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

Primary outcomes

  1. Gradation of quality of recorded signals at home

    Time frame: at day 1

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

Study contacts

Contact information is provided by the study sponsor or research team.

Frédéric Lofaso, MD, PhD

CONTACT

[email protected]

+33 (0)1 47 10 79 41

Hélène Prigent, MD, PhD

CONTACT

[email protected]

+33 (0)1 47 10 79 40

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Association Française contre les Myopathies (AFM), Paris

Registry information

Official study title

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

Acronym: HPforNIV

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2023
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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