Alleviating Persistent Dyspnea in Amyotrophic Lateral Sclerosis Patients Treated With Non-Invasive Ventilation Through Immersive Virtual Reality
Recruiting now · Not applicable
Conditions studied: Amyotrophic Lateral Sclerosis
In brief
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.
Key facts
- Study ID
- NCT06021938
- Run by
- Assistance Publique - Hôpitaux de Paris
- People needed
- 35
- Starts
- 2024-04-04
- Expected to finish
- 2027-04-04
- Last updated by the study team
- 2026-02-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥ 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)
You may not qualify if…
- 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
Where it is running
- Service de Pneumologie — Paris, France, France (enrolling)
Full record on ClinicalTrials.gov
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