Using virtual reality to ease breathing difficulties in ALS patients on ventilation
Alleviating Persistent Dyspnea in Amyotrophic Lateral Sclerosis Patients Treated With Non-Invasive Ventilation Through Immersive Virtual Reality
NA · Assistance Publique - Hôpitaux de Paris · NCT06021938
This study is testing if virtual reality can help ease breathing difficulties for ALS patients who use a ventilator.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 1 site (Paris, France) |
| Trial ID | NCT06021938 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of immersive virtual reality (IVR) as a therapeutic alternative for alleviating persistent dyspnea in patients with amyotrophic lateral sclerosis (ALS) who are treated with non-invasive ventilation (NIV). It aims to assess the impact of IVR on respiratory discomfort using the Multidimensional Dyspnea Profile questionnaire. The study will be conducted in an open-label, monocentric, randomized, controlled cross-over design at the Pneumology Department of Pitié Salpêtrière Hospital. Patients will be recruited during their routine respiratory evaluations and will undergo a thorough eligibility screening process.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of ALS, experiencing respiratory failure treated with NIV, and persistent dyspnea.
Not a fit: Patients with recent neurological disorders or severe psychiatric illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for ALS patients experiencing persistent breathing difficulties.
How similar studies have performed: While the use of immersive virtual reality in medical settings is emerging, this specific application for ALS patients with persistent dyspnea is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris, France
- Service de Pneumologie — Paris, France, France (RECRUITING)
Study contacts
- Study coordinator: Capucine MORELOT-PANZINI
- Email: capucine.morelot@aphp.fr
- Phone: 01 42 16 77 71
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Amyotrophic Lateral Sclerosis, Persistent Dyspnea, Non-Invasive Ventilation, Immersive Virtual Reality