NCT04791748 Virtual Reality in Children With and Without Vestibular Deficits
| NCT ID | NCT04791748 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Vestibular Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2021-04-12 |
| Primary Completion | 2027-02 |
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 140 participants in total. It began in 2021-04-12 with a primary completion date of 2027-02.
⚠ 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
Vestibular information is important in establishing a child's static and dynamic postural control. Any vestibular deficit can have major consequences on development, spatial cognition and quality of life. In order to interact with the world around us, we must simultaneously integrate different sources of sensory informations (vision, hearing, perception of the body...). The brain integrates these different sensory components to form a unified and coherent perception: this is multisensory integration. Multisensory integration has been studied using virtual reality in adults, in the "spatial orientation" team of the Center for Integrative Neurosciences and Cognition. These experiments were carried out on healthy subjects and in weightless situations (international space station or parabolic flight). However, no protocol has been developed in children or in subjects with vestibular deficit. Virtual reality is interesting for developing such a protocol because it creates multisensory stimulation capable of promoting visual and proprioceptive compensation of the vestibular deficit. It induces an immersion of the patient in a virtual spatial and temporal environment difficult to carry out with traditional vestibular rehabilitation techniques. Its main advantage is that it is a fun and safe interactive diagnostic and therapeutic tool, which is particularly suitable for children. Being able to modulate certain sensory information using virtual reality, in children without vestibular function deficit and in children with vestibular function deficit, will make it possible to better understand the role of the vestibule in the construction of the self in relation to space and environment. In addition to the scientific aspect, the diagnostic and therapeutic benefits are potentially numerous. The objective of the study is to determine a reliable, well-tolerated and age-appropriate virtual reality protocol in children without vestibular deficit and in children with chronic vestibular deficit, making it possible to study the hand-eye coordination.
Eligibility Criteria
Inclusion Criteria: * Minors aged 7 to 17 years (inclusive) * Volunteers adult * Information and consent of holders of parental authority of minors, minors and of adult subjects Patients : * Presence of unilateral or bilateral chronic vestibular pathology * Minor patients followed in consultation at Necker Hospital in the Pediatric ENT department * Adult patients followed at adult vestibulometry services (Lariboisière and Pitié Salpêtrière Hospitals) Controls: * No history of otological surgery and absence of vestibular pathology * Patients followed in consultation at Necker Hospital, siblings or adult parents Exclusion Criteria: * Presence of an ophthalmological pathology (including refractive errors) * Presence of neurological pathology including epilepsy or any pathology that can alter mobility and interfere with the performance of tasks
Contact & Investigator
Françoise Denoyelle, MD, PhD
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT04791748 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, studying Vestibular Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04791748 currently recruiting?
Yes, NCT04791748 is actively recruiting participants. Contact the research team at f.denoyelle@aphp.fr for enrollment information.
Where is the NCT04791748 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT04791748 clinical trial?
NCT04791748 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Françoise Denoyelle, MD, PhD at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 140 participants.