Alleviating Persistent Dyspnea in Amyotrophic Lateral Sclerosis Patients Treated With Non-Invasive Ventilation Through Immersive Virtual Reality

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Aug 25, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help people with Amyotrophic Lateral Sclerosis (ALS) who have ongoing trouble breathing, even while using a device called non-invasive ventilation (NIV). NIV helps support the breathing muscles, but many patients still feel short of breath. The study aims to see if using immersive virtual reality (IVR) can reduce this feeling of breathlessness. IVR is a technology that creates a virtual environment, which may help distract patients and make them feel more comfortable.

To join the study, participants need to be at least 18 years old and have a confirmed diagnosis of ALS. They should have been using NIV for more than a month and still experience significant breathing discomfort at rest. Participants must be stable in their health and able to give informed consent. People with certain other neurological or psychiatric conditions, or specific phobias, may not be eligible. If you or someone you know is interested, participants can expect to try out this new approach while receiving care in a supportive environment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • ≥ 18 years old
• • Diagnosis of ALS confirmed according to the revised criteria of El Escorial
• • Respiratory failure due to diaphragmatic dysfunction treated by non-invasive ventilation for more than a month
• • Care provided in an ambulatory setting (day care hospital)
• • Persistent dyspnea at rest ≥ 3 across a numerical scale (0 to 10) in a semi-sitting position
• • Stable clinical condition, i.e., no episode of acute cardiac, respiratory and/or neurological failure leading to hospitalization in the previous 4 weeks
• • Free, prior and informed written consent about the study has been obtained
• • Benefiting a social security (French health insurance system)
• Exclusion Criteria:
• • Neurological disorders according to a neurological evaluation dating from less than one year, in particular diagnosed dementia (frontotemporal dementia, Alzheimer's disease, etc.), brain pathology (tumor, stroke, Parkinson's disease, etc.)
• • Diagnosed psychiatric illness (severe depression, psychosis) or receiving antipsychotic treatment
• • Acrophobia
• • Claustrophobia
• • Photophobia
• • Hearing loss
• • Visual impairment
• • Subject under guardianship or curatorship