Clinical trial NCT06021938: Alleviating Persistent Dyspnea in Amyotrophic Lateral Sclerosis Patients Treated With Non-Invasive Ventilation Through Immersive Virtual Reality
Official title: Alleviating Persistent Dyspnea in Amyotrophic Lateral Sclerosis Patients Treated With Non-Invasive Ventilation Through Immersive Virtual Reality
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Persistent Dyspnea
Non-Invasive Ventilation
Immersive Virtual Reality
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-09-01
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the effect of IVR on respiratory discomfort (A1)
timeFrame: 15 minutes
Secondary outcomes:
measure: Evaluate the effect of IVR on respiratory discomfort (QS and A2)
timeFrame: 15 minutes
measure: Evaluate the effect of music therapy on respiratory discomfort (QS, A1 and A2)
timeFrame: 15 minutes
measure: Compare the evolutionary profile on respiratory discomfort (QS, A1 and A2) under the effect of IVR and music therapy
timeFrame: 15 minutes
measure: Compare the effect of IVR and music therapy on the respiratory discomfort in terms of preference.
timeFrame: 15 minutes
measure: Evaluate the acceptability of IVR
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de Pneumologie
Study officials:
References: