NCT06021938Recruiting
Alleviating Persistent Dyspnea in Amyotrophic Lateral Sclerosis Patients Treated With Non-Invasive Ventilation Through Immersive Virtual Reality
Source: ClinicalTrials.gov · Last updated 25 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 35 (estimated)
- First submitted
- 25 Aug 2023
- Start date
- 4 Apr 2024
- Primary completion date
- 4 Apr 2027
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT06021938
What you commit to
- Study type: Interventional
- Planned participants: 35
- From 4 Apr 2024 to the primary completion date, 4 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Diagnosed psychiatric illness (severe depression, psychosis) or receiving antipsychotic treatment
Other illness
- 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.)
- Visual impairment
Other
- Acrophobia
- Claustrophobia
- Photophobia
- Hearing loss
- Subject under guardianship or curatorship
Who the study is looking for
- ≥ 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Service de Pneumologie Coordinator of this site? Confirm its status | Paris | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.