Alleviating Persistent Dyspnea in Amyotrophic Lateral Sclerosis Patients Treated With Non-Invasive Ventilation Through Immersive Virtual Reality
RVI-SLA
1 other identifier
interventional
35
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2023
CompletedFirst Posted
Study publicly available on registry
September 1, 2023
CompletedStudy Start
First participant enrolled
April 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 4, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 4, 2027
February 25, 2026
February 1, 2026
3 years
August 25, 2023
February 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate the effect of IVR on respiratory discomfort (A1)
Evaluate the effect of IVR on respiratory discomfort (scale A1 of the MDP questionnaire) of patients with ALS at the stage of respiratory failure treated with NIV
15 minutes
Secondary Outcomes (5)
Evaluate the effect of IVR on respiratory discomfort (QS and A2)
15 minutes
Evaluate the effect of music therapy on respiratory discomfort (QS, A1 and A2)
15 minutes
Compare the evolutionary profile on respiratory discomfort (QS, A1 and A2) under the effect of IVR and music therapy
15 minutes
Compare the effect of IVR and music therapy on the respiratory discomfort in terms of preference.
15 minutes
Evaluate the acceptability of IVR
15 minutes
Study Arms (2)
Patients starting with RVI
ACTIVE COMPARATORPatients will begin by wear a virtual reality headset (GAMIDA®) and headphones (Bose®). A tablet (Samsung®) equipped with "Healthy Mind" software will allow patients to live a 360° visual and auditory 3D experience via Bluetooth connection. After that patients will be handed a smartphone with the Spotify® application to listen to music. Patients will wear headphones.
Patients starting with music therapy
ACTIVE COMPARATORPatients will begin by handed a smartphone with the Spotify® application to listen to music. Patients will wear headphones. After that patients will wear a virtual reality headset (GAMIDA®) and headphones (Bose®). A tablet (Samsung®) equipped with "Healthy Mind" software will allow patients to live a 360° visual and auditory 3D experience via Bluetooth connection.
Interventions
The patient will be offered a digital therapy session based on immersive virtual reality (IVR) and a music therapy session, 60 minutes apart. The IVR session will be based on medical hypnosis (GAMIDA®) and the music therapy session will be based on the choice of music the patient wishes. Each session will last 15 minutes. Patients will start either with the medical hypnosis session by IVR or with the music session depending on the randomization carried out before the start of the study. The random order will be provided by software (CleanWeb).
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service de Pneumologie
Paris, France, 75013, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2023
First Posted
September 1, 2023
Study Start
April 4, 2024
Primary Completion (Estimated)
April 4, 2027
Study Completion (Estimated)
April 4, 2027
Last Updated
February 25, 2026
Record last verified: 2026-02