NCT06021938

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2024-04-04
• Primary completion: 2027-04-04
• Completion: 2027-04-04
• First posted: 2023-09-01
• Last updated: 2026-02-25

Locations

1 site across 1 country: France