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

Study Overview
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Brief Summary
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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.

Detailed Description
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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). The objective of this study is to evaluate the effect of IVR on respiratory discomfort (scale A1 of the Multidimensional Dyspnea Profile (MDP) questionnaire) of patients with ALS at the stage of respiratory failure treated with NIV. This will be an open-label, monocentric, randomized, controlled cross-over clinical study. ALS patients will be recruited during their respiratory evaluation carried out as part of their usual care provided in an ambulatory setting (day care hospital) in the Pneumology Department of Pitié Salpêtrière Hospital. Eligibility criteria will be verified during this visit. If the patient meets eligibility criteria, the investigator will present the study to him using the information letter. After a period of reflection that the patient deems necessary to make his decision and after having obtained an answer to all his questions, his written consent will be collected by the investigator. The patient will then 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 that 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).

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

Conditions
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Amyotrophic Lateral Sclerosis

Intervention / Treatment
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* Device: Immersive virtual reality (IVR) & Music therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients starting with RVI<br>Patients 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. | Device: Immersive virtual reality (IVR) & Music therapy<br>* 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).<br>|
| Active Comparator: Patients starting with music therapy<br>Patients 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. | Device: Immersive virtual reality (IVR) & Music therapy<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effect of IVR on respiratory discomfort (QS and A2) | Evaluate the effect of IVR on the sensory (scale QS of the MDP questionnaire) and emotional (scale A2 of the MDP questionnaire) components of dyspnea of patients with ALS at the stage of respiratory failure treated with NIV. | 15 minutes | 
| Evaluate the effect of music therapy on respiratory discomfort (QS, A1 and A2) | Evaluate the effect of music therapy on the sensory (scale QS of the MDP questionnaire), affective (scale A1 of the MDP questionnaire) and emotional (scale A2 of the MDP questionnaire) components of dyspnea of patients with ALS at the stage of respiratory failure treated with NIV. | 15 minutes | 
| Compare the evolutionary profile on respiratory discomfort (QS, A1 and A2) under the effect of IVR and music therapy | Compare the evolutionary profile of the sensory ( scale QS of the MDP questionnaire ) and affective ( scale A1 and A2 of the MDP questionnaire) components of dyspnea 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. | Compare the effect of IVR and music therapy on the respiratory discomfort of ALS patients treated with NIV in terms of preference through a post-exposure questionnaire after the two interventions | 15 minutes | 
| Evaluate the acceptability of IVR | Evaluate the effect of IVR on dyspnea in terms of acceptability by a subjective questionnaire of six questions using a 7-point Likert scale. | 15 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Persistent Dyspnea, Non-Invasive Ventilation, Immersive Virtual Reality