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

RecruitingNAAges 18 Years - anyAllAssistance Publique - Hôpitaux de Paris
NCT06021938 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The evolution of amyotrophic lateral sclerosis (ALS) is marked by dyspnea, anxiety and pain, major determinants of suffering induced by this disease. The only palliative treatment for respiratory failure is non-invasive ventilation (NIV), which compensates failing respiratory muscles and relieves dyspnea, improves quality of life and increases life expectancy. In ALS patients, the persistence of dyspnea outside of NIV sessions has highlighted the need for therapeutic alternatives in the treatment of persistent dyspnea, including immersive virtual reality (IVR) and auditory distraction through music (music therapy). This study evaluates the effect of IVR on respiratory discomfort in ALS patients with persistent dyspnea treated with NIV.

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📋 Eligibility rules (as published)
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
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What it tests

  • Immersive virtual reality (IVR) & Music therapy
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Where

1 site
Service de Pneumologie
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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