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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥ 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)

Locations
Other Locations
France
Service de Pneumologie
RECRUITING
Paris
Contact Information
Primary
Capucine MORELOT-PANZINI
capucine.morelot@aphp.fr
01 42 16 77 71
Backup
Thomas SIMILOWSKI
thomas.similowski@aphp.fr
01 42 16 78 84
Time Frame
Start Date: 2024-04-04
Estimated Completion Date: 2026-04-04
Participants
Target number of participants: 35
Treatments
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.
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.
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov