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

November 19, 2025 updated by: Assistance Publique - Hôpitaux de Paris

Initiation of Polygraphy for Neuromuscular Disease 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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Frédéric Lofaso, MD, PhD
  • Phone Number: +33 (0)1 47 10 79 41
  • Email: f.lofaso@aphp.fr

Study Contact Backup

Study Locations

  • France
      • Garches, France, 92380
        • Recruiting
        • Department of physiology and functional explorations - Raymond Poincaré Hospital - APHP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Initiation a non-invasive ventilation at night
Neuromuscular patients with chronic respiratory failure who initiate a non-invasive ventilation at night.
Procedure: Polygraphy diagnostic at home
Polygraphy diagnostic at home for patients under non-invasive mechanical ventilation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Association Française contre les Myopathies (AFM), Paris

Investigators

  • Principal Investigator: Frédéric Lofaso, MD, PhD, Department of physiology and functional explorations - Raymond Poincaré Hospital - APHP
  • Study Director: Hélène Prigent, MD, PhD, Department of physiology and functional explorations - Raymond Poincaré Hospital - APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

March 14, 2023

First Posted (Actual)

March 27, 2023

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP230176
  • 2022-A01925-38 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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