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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05785637
Acronym
HPforNIV
Enrollment
25
Registered
2023-03-27
Start date
2024-03-08
Completion date
2026-03-31
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromuscular Diseases

Keywords

Neuromuscular Diseases, Polygraphy

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).

Interventions

PROCEDUREPolygraphy diagnostic at home

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

Sponsors

Association Française contre les Myopathies (AFM), Paris
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Gradation of quality of recorded signals at homeat day 1Expressed in number of readable signals for which the readability will be expressed in % of record time.

Countries

France

Contacts

Primary ContactFrédéric Lofaso, MD, PhD
f.lofaso@aphp.fr+33 (0)1 47 10 79 41
Backup ContactHélène Prigent, MD, PhD
helene.prigent@aphp.fr+33 (0)1 47 10 79 40

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026