Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06021938

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

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-02-25

35

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years old or older
  • Diagnosis of ALS confirmed by El Escorial revised criteria
  • Respiratory failure from diaphragmatic dysfunction treated with non-invasive ventilation for over one month
  • Care provided in an outpatient day care hospital setting
  • Persistent breathlessness at rest with a score of 3 or higher on a 0 to 10 scale while semi-sitting
  • Clinically stable with no acute cardiac, respiratory, or neurological failure requiring hospitalization in the past 4 weeks
  • Provided free, prior, and informed written consent to participate
  • Covered by French social security health insurance
Not Eligible

You will not qualify if you...

  • Neurological disorders diagnosed within the past year, including dementia or brain diseases like tumors, stroke, or Parkinson's
  • Diagnosed psychiatric illness such as severe depression or psychosis, or currently receiving antipsychotic treatment
  • Fear of heights (acrophobia)
  • Claustrophobia
  • Sensitivity to light (photophobia)
  • Hearing loss
  • Visual impairment
  • Under legal guardianship or curatorship

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Service de Pneumologie

Paris, France, France, 75013

Actively Recruiting

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Research Team

C

Capucine MORELOT-PANZINI

CONTACT

T

Thomas SIMILOWSKI

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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