Virtual Reality and Subjective Tinnitus (ReVA2)

Institut de recherche et de coordination acoustique/musique, Institut National de la Santé Et de la Recherche Médicale, France, Immersive Therapy

The purpose of this study is to test if virtual reality immersion has the potential to significantly decrease subjective tinnitus intrusiveness when compared to standard care.

This is a randomised controlled study aimed at further validating the use of Virtual Reality in the field of subjective tinnitus management. Indeed, earlier results have suggested that this innovative strategy has the potential to be as efficient as a Cognitive and Behavioural Therapy. Before the sessions, an automated tinnitus matching procedure will help create a sound similar to the tinnitus percept ("Tinnitus Avatar"). During the sessions (8 sessions; 30 minutes), the "Tinnitus Avatar" will be displayed auditorily but also visually - as a sparkling spot - in a variety of virtual 3D auditory and visual environments. In these virtual environments the patients will be given the possibility to voluntarily control and manipulate the "Tinnitus Avatar" by the means of a wand on top of which the sound and the sparkling will be attached. They will also be able to freely navigate in the virtual scenes where environmental sound will be displayed. Then the patients will be able to displace at will the "Tinnitus Avatar" in their peri-personal space or mask it by getting close to sounds they may encounter in the virtual scenes. It is supposed that regaining and training a capacity of interaction with the "Tinnitus Avatar" as if it were a standard sound will help recalibrate the attentional processes involved in tinnitus perception and then to decrease tinnitus intrusiveness.

14 item questionnaire (validated in French) Score 0 to 21 (maximum anxiety) Score 0 to 21 (maximum depression)

Inclusion Criteria: Age > 18 years and < 75 years, French speaking and ability to understand multidimensional questionnaires, Subjective tinnitus of peripheral origin (middle or inner ear auditory nerve) Subjective tinnitus stable and chronic (lasting for more than 6 months) Subjective tinnitus that can be characterized by tinnitus matching Normal hearing or moderate hearing loss Exclusion Criteria: Fluctuating tinnitus, Unilateral or bilateral severe or profound hearing loss, Claustrophobia, visual, impairment, vertigo or dizziness, chronic headache or any other condition contraindicating virtual immersion Psychiatric condition requiring immediate management Pregnant or breastfeeding women Protected adults (including individual under guardianship by court order) Persons deprived of their liberty by judicial or administrative decision

Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. Data sharing must respect the agreements made with funders. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement. Processing of shared data must comply with European General Data Protection Regulation (GDPR).

Malinvaud D, Londero A, Niarra R, Peignard P, Warusfel O, Viaud-Delmon I, Chatellier G, Bonfils P. Auditory and visual 3D virtual reality therapy as a new treatment for chronic subjective tinnitus: Results of a randomized controlled trial. Hear Res. 2016 Mar;333:127-135. doi: 10.1016/j.heares.2015.12.023. Epub 2016 Jan 8.