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

• ClinicalTrials.gov Identifier: NCT06021938
• Recruitment Status: Recruiting
• First Posted: September 1, 2023
• Last Update Posted: April 5, 2024
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Amyotrophic Lateral Sclerosis	Device: Immersive virtual reality (IVR) & Music therapy	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Alleviating Persistent Dyspnea in Amyotrophic Lateral Sclerosis Patients Treated With Non-Invasive Ventilation Through Immersive Virtual Reality
• Actual Study Start Date: April 4, 2024
• Estimated Primary Completion Date: April 4, 2026
• Estimated Study Completion Date: April 4, 2026

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Patients starting with RVI; 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; 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).
Active Comparator: Patients starting with music therapy; 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; 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).

Outcome Measures

Primary Outcome Measures :

1. Evaluate the effect of IVR on respiratory discomfort (A1) [ Time Frame: 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 Outcome Measures :

1. Evaluate the effect of IVR on respiratory discomfort (QS and A2) [ Time Frame: 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.
2. Evaluate the effect of music therapy on respiratory discomfort (QS, A1 and A2) [ Time Frame: 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.
3. Compare the evolutionary profile on respiratory discomfort (QS, A1 and A2) under the effect of IVR and music therapy [ Time Frame: 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.
4. Compare the effect of IVR and music therapy on the respiratory discomfort in terms of preference. [ Time Frame: 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
5. Evaluate the acceptability of IVR [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Capucine MORELOT-PANZINI; 01 42 16 77 71; capucine.morelot@aphp.fr

Contact: Thomas SIMILOWSKI; 01 42 16 78 84; thomas.similowski@aphp.fr

Locations

France

Service de Pneumologie; Recruiting

Paris, France, 75013

Contact: Capucine MORELOT PANZINI 01 42 16 77 71 ext 33 capucine.morelot@aphp.fr

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

More Information

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT06021938
• Other Study ID Numbers: APHP230974
• First Posted: September 1, 2023
• Last Update Posted: April 5, 2024
• Last Verified: April 2024

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Persistent Dyspnea; Non-Invasive Ventilation; Immersive Virtual Reality

Additional relevant MeSH terms:

Dyspnea; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis; Pathologic Processes; Neurodegenerative Diseases; Nervous System Diseases; Neuromuscular Diseases; Spinal Cord Diseases; Central Nervous System Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory