Virtual Reality and Subjective Tinnitus (ReVA2)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Tinnitus, Subjective; Tinnitus

Treatments: Other: Virtual Reality; Behavioral: Standard treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04987502

2021-A01045-36 (Registry Identifier)

APHP210808

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

Virtual reality treatment

Experimental group

Description:

Virtual reality immersion with 3D audio and visual rendering (8 weekly sessions)

Treatment:

Other: Virtual Reality

Standard treatment

Active Comparator group

Description:

Counselling Relaxation techniques Sound enrichment

Treatment:

Behavioral: Standard treatment