Amyotrophic Lateral SclerosisRVI-SLANCT06021938
Alleviating Persistent Dyspnea in Amyotrophic Lateral Sclerosis Patients Treated With Non-Invasive Ventilation Through Immersive Virtual Reality
A study testing Immersive virtual reality (IVR) & Music therapy in people with Amyotrophic Lateral Sclerosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Immersive virtual reality (IVR) & Music therapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 4 Apr 2024to 4 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Pneumologie
Paris, France, 75013
Capucine MORELOT PANZINI, 01 42 16 77 71 ext. 33, capucine.morelot@aphp.fr
About this study
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.
Read the 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
- Being tested
- Immersive virtual reality (IVR) & Music therapy
- Keywords
- Persistent Dyspnea, Non-Invasive Ventilation, Immersive Virtual Reality
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive virtual reality (IVR) & Music therapyDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Patients starting with RVI | Active comparator | 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. Receives: Device: Immersive virtual reality (IVR) & Music therapy |
| Patients starting with music therapy | Active comparator | 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. Receives: Device: Immersive virtual reality (IVR) & Music therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effect of IVR on respiratory discomfort (A1)
Evaluate the effect of IVR on respiratory discomfort (scale A1 of the MDP questionnaire) of patients with ALS at the stage of respiratory failure treated with NIV
Measured: 15 minutes
Secondary outcomes (5)
Evaluate the effect of IVR on respiratory discomfort (QS and A2)
Evaluate the effect of IVR on the sensory (scale QS of the MDP questionnaire) and emotional (scale A2 of the MDP questionnaire) components of dyspnea of patients with ALS at the stage of respiratory failure treated with NIV.
Measured: 15 minutes
Evaluate the effect of music therapy on respiratory discomfort (QS, A1 and A2)
Evaluate the effect of music therapy on the sensory (scale QS of the MDP questionnaire), affective (scale A1 of the MDP questionnaire) and emotional (scale A2 of the MDP questionnaire) components of dyspnea of patients with ALS at the stage of respiratory failure treated with NIV.
Measured: 15 minutes
Compare the evolutionary profile on respiratory discomfort (QS, A1 and A2) under the effect of IVR and music therapy
Compare the evolutionary profile of the sensory ( scale QS of the MDP questionnaire ) and affective ( scale A1 and A2 of the MDP questionnaire) components of dyspnea under the effect of IVR and music therapy.
Measured: 15 minutes
Compare the effect of IVR and music therapy on the respiratory discomfort in terms of preference.
Compare the effect of IVR and music therapy on the respiratory discomfort of ALS patients treated with NIV in terms of preference through a post-exposure questionnaire after the two interventions
Measured: 15 minutes
Evaluate the acceptability of IVR
Evaluate the effect of IVR on dyspnea in terms of acceptability by a subjective questionnaire of six questions using a 7-point Likert scale.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start4 Apr 2024
- Primary completion4 Apr 2027 (estimated)
- Study completion4 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021938
- Sponsor's protocol ID
- APHP230974
- Acronym
- RVI-SLA
- Status last verified
- Feb 2026
- First submitted
- 25 Aug 2023
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alleviating Persistent Dyspnea in Amyotrophic Lateral Sclerosis Patients Treated With Non-Invasive Ventilation Through Immersive Virtual Reality
- ClinicalTrials.gov ID
- NCT06021938
- Acronym / sponsor ID
- RVI-SLA / APHP230974
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Persistent Dyspnea, Non-Invasive Ventilation, Immersive Virtual Reality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 4 Apr 2027 (estimated)
- Study completion
- 4 Apr 2027 (estimated)
- First posted
- 1 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients starting with RVI | Active comparator | Device: Immersive virtual reality (IVR) & Music therapyPatients 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. |
| Patients starting with music therapy | Active comparator | Device: Immersive virtual reality (IVR) & Music therapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive virtual reality (IVR) & Music therapyThe 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). | Device | Patients starting with RVI, Patients starting with music therapy |
Primary outcome
Evaluate the effect of IVR on respiratory discomfort (A1)
Time frame: 15 minutes
Evaluate the effect of IVR on respiratory discomfort (scale A1 of the MDP questionnaire) of patients with ALS at the stage of respiratory failure treated with NIV
5 secondary outcomes
Evaluate the effect of IVR on respiratory discomfort (QS and A2)
Time frame: 15 minutes
Evaluate the effect of music therapy on respiratory discomfort (QS, A1 and A2)
Time frame: 15 minutes
Compare the evolutionary profile on respiratory discomfort (QS, A1 and A2) under the effect of IVR and music therapy
Time frame: 15 minutes
Compare the effect of IVR and music therapy on the respiratory discomfort in terms of preference.
Time frame: 15 minutes
Evaluate the acceptability of IVR
Time frame: 15 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive virtual reality (IVR) & Music therapy in people with Amyotrophic Lateral Sclerosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Capucine MORELOT-PANZINI (01 42 16 77 71, capucine.morelot@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effect of IVR on respiratory discomfort (A1) (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.