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

NCT05785637 | Recruiting

• 2 other identifiers: APHP2301762022-A01925-38
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Neuromuscular Diseases

Keywords

Neuromuscular Diseases; Polygraphy

Outcome Measures

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.

  at day 1

Study Arms (1)

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

Interventions

Polygraphy diagnostic at home PROCEDURE

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

Initiation a non-invasive ventilation at night

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Association Française contre les Myopathies (AFM), Paris: collaborator

Study Sites (1)

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

Garches, 92380, France

RECRUITING

MeSH Terms

Conditions

Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

• Frédéric Lofaso, MD, PhD

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

  PRINCIPAL INVESTIGATOR

• Hélène Prigent, MD, PhD

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

  STUDY DIRECTOR

Central Study Contacts

Frédéric Lofaso, MD, PhD

CONTACT

+33 (0)1 47 10 79 41; f.lofaso@aphp.fr

Hélène Prigent, MD, PhD

CONTACT

+33 (0)1 47 10 79 40; helene.prigent@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: March 27, 2023
• Study Start: March 8, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)