Amyotrophic Lateral Sclerosis
Conditions
Keywords
Persistent Dyspnea, Non-Invasive Ventilation, Immersive Virtual Reality
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.
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 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).
Interventions
DEVICEImmersive virtual reality (IVR) & Music therapy
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).
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the effect of IVR on respiratory discomfort (A1) | 15 minutes | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare the effect of IVR and music therapy on the respiratory discomfort in terms of preference. | 15 minutes | 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 |
| Evaluate the acceptability of IVR | 15 minutes | Evaluate the effect of IVR on dyspnea in terms of acceptability by a subjective questionnaire of six questions using a 7-point Likert scale. |
| Evaluate the effect of IVR on respiratory discomfort (QS and A2) | 15 minutes | 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. |
| Evaluate the effect of music therapy on respiratory discomfort (QS, A1 and A2) | 15 minutes | 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. |
| Compare the evolutionary profile on respiratory discomfort (QS, A1 and A2) under the effect of IVR and music therapy | 15 minutes | 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. |
Countries
France
Contacts
CONTACTCapucine MORELOT-PANZINI
CONTACTThomas SIMILOWSKI
Outcome results
None listed