NCT06021938 Alleviating Persistent Dyspnea in Amyotrophic Lateral Sclerosis Patients Treated With Non-Invasive Ventilation Through Immersive Virtual Reality
| NCT ID | NCT06021938 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Amyotrophic Lateral Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2024-04-04 |
| Primary Completion | 2027-04-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 35 participants in total. It began in 2024-04-04 with a primary completion date of 2027-04-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06021938 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Amyotrophic Lateral Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06021938 currently recruiting?
Yes, NCT06021938 is actively recruiting participants. Contact the research team at capucine.morelot@aphp.fr for enrollment information.
Where is the NCT06021938 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06021938 clinical trial?
NCT06021938 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 35 participants.
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