Status:
RECRUITING
Alleviating Persistent Dyspnea in Amyotrophic Lateral Sclerosis Patients Treated With Non-Invasive Ventilation Through Immersive Virtual Reality
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 fail...
Detailed Description
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 fail...
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
April 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 4 2026
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06021938
Start Date
April 4 2024
End Date
April 4 2026
Last Update
July 3 2025
Active Locations (1)
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1
Service de Pneumologie
Paris, France, France, 75013