Home polygraphy for neuromuscular patients using non-invasive ventilation

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

This study is testing if doing sleep tests at home can help people with neuromuscular diseases who use non-invasive ventilation get better nighttime support for their breathing.

Quick facts

• Study type: Observational
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (other)
• Locations: 1 site (Garches)
• Trial ID: NCT05785637 on ClinicalTrials.gov

What this trial studies

This study evaluates the feasibility and utility of conducting polygraphic assessments at home for patients with neuromuscular diseases who are using non-invasive ventilation. The aim is to assess the effectiveness of nighttime ventilation and optimize ventilator settings based on the collected data. By monitoring patients in their home environment, the study seeks to improve the management of chronic respiratory insufficiency. The approach involves patients who have recently started non-invasive ventilation in a hospital setting.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic respiratory insufficiency who have recently initiated non-invasive ventilation.

Not a fit: Patients who may not benefit include those with rapidly evolving neuromuscular conditions or those requiring extensive mechanical ventilation.

Why it matters

Potential benefit: If successful, this study could enhance the management of respiratory insufficiency in neuromuscular patients, leading to improved patient outcomes.

How similar studies have performed: While similar approaches have been explored, this specific method of home polygraphy for neuromuscular patients is relatively novel.

Eligibility criteria

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).

Where this trial is running

Garches

• Department of physiology and functional explorations - Raymond Poincaré Hospital - APHP — Garches, France (RECRUITING)

Study contacts

• Principal investigator: Frédéric Lofaso, MD, PhD — Department of physiology and functional explorations - Raymond Poincaré Hospital - APHP
• Study coordinator: Frédéric Lofaso, MD, PhD

Conditions: Neuromuscular Diseases, Polygraphy