Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Using virtual reality to ease breathing difficulties in ALS patients on ventilation

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

Run by Assistance Publique - Hôpitaux de Paris · NCT06021938 · Data updated 2026-11-12

This study is testing if virtual reality can help ease breathing difficulties for ALS patients who use a ventilator.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment35 (estimated)
SponsorAssistance Publique - Hôpitaux de Paris
Academic / other
Locations1 site (Paris, France)
StatusRecruiting
StartedApril 4, 2024
Main results expectedApril 4, 2027
Study endsApril 4, 2027
Registry record updatedFebruary 25, 2026
Trial IDNCT06021938 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

Patients with recent neurological disorders or severe psychiatric illnesses may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Service de Pneumologie
    Paris, France, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Implanted Brain-Computer Interface to Help People with Severe Arm Impairment

    We’re testing the N1 System, a fully implanted brain interface in the motor cortex with a robot, to see if it can help adults with spinal cord injury, ALS, or chronic stroke use a computer or keyboard more easily.

    Recruiting Neuralink Corp · Miami, Florida · NCT07929792

  • Brain-computer interface chat tool for people with ALS

    This test compares a wearable brain-computer interface communication device to eye-tracking devices that people with ALS currently use to help them communicate.

    Recruiting Cognixion · Santa Barbara, California · NCT07871071

  • BIIB147 safety and how it behaves in adults with ALS

    This study tests BIIB147 in adults with ALS to see if it is safe and how the body handles it, including early and long-term effects.

    Recruiting at 2 sites Phase 1/2 Biogen · St Louis, Missouri and 1 other locations · NCT07855211

  • Aims to restore UNC13A function in people with ALS

    This trial tests TRCN-1023 in adults with ALS to see if it’s safe, tolerated, and shows early signs of benefit.

    Recruiting at 6 sites Phase 1/2 Trace Neuroscience, Inc. · Lübeck, Schleswig-Holstein and 5 other locations · NCT07674667

  • LTX-002 in adults with ALS

    A study will test whether the experimental drug LTX-002 is safe and tolerable in adults with ALS and see how the body handles the drug and how it affects ALS indicators.

    Recruiting at 4 sites Phase 1/2 Leal Therapeutics, Inc · Lübeck and 4 other locations · NCT07660614

  • Repeated ultrasound-assisted blood-brain barrier opening in ALS

    This trial tests whether repeatedly opening the blood-brain barrier with ultrasound is safe and may help people with ALS.

    Recruiting Phase 1/2 Assistance Publique - Hôpitaux de Paris · Paris · NCT07571486

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.