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

Neuromuscular Diseases Clinical Trial

— HPforNIV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05785637
• Other study ID #: APHP230176
• Secondary ID: 2022-A01925-38
• Status: Recruiting
• Start date: March 8, 2024
• Est. completion date: March 2026

Study information

• Verified date: April 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Frédéric Lofaso, MD, PhD
• Phone: +33 (0)1 47 10 79 41
• Email: f.lofaso[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Neuromuscular Diseases

Intervention

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

Locations

Country	Name	City	State
France	Department of physiology and functional explorations - Raymond Poincaré Hospital - APHP	Garches

Sponsors (2)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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