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

NCT ID: NCT05785637

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-08

Study Completion Date

2026-03-31

Brief Summary

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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).

Detailed Description

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Conditions

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Neuromuscular Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Initiation a non-invasive ventilation at night

Neuromuscular patients with chronic respiratory failure who initiate a non-invasive ventilation at night.

Polygraphy diagnostic at home

Intervention Type PROCEDURE

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

Interventions

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Polygraphy diagnostic at home

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

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Association Française contre les Myopathies (AFM), Paris

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frédéric Lofaso, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Hélène Prigent, MD, PhD

Role: STUDY_DIRECTOR

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

Locations

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

Garches, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Frédéric Lofaso, MD, PhD

Role: CONTACT

+33 (0)1 47 10 79 41

Hélène Prigent, MD, PhD

Role: CONTACT

+33 (0)1 47 10 79 40

Other Identifiers

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2022-A01925-38

Identifier Type: REGISTRY

Identifier Source: secondary_id

APHP230176

Identifier Type: -

Identifier Source: org_study_id

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