Virtual Reality and Subjective Tinnitus

NCT ID: NCT04987502

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-07
• Study Completion Date: 2024-05-31

Brief Summary

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.

Detailed 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.

Conditions

Tinnitus; Tinnitus, Subjective

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Virtual reality treatment

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

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: OTHER

8 sessions of virtual reality with 3D audio and visual rendering

Standard treatment

Counselling Relaxation techniques Sound enrichment

Group Type: ACTIVE_COMPARATOR

Standard treatment

Intervention Type: BEHAVIORAL

counselling, relaxation techniques, sound enrichment

Interventions

Virtual Reality

8 sessions of virtual reality with 3D audio and visual rendering

Intervention Type: OTHER

Standard treatment

counselling, relaxation techniques, sound enrichment

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut de recherche et de coordination acoustique/musique

UNKNOWN

Sponsor Role: collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

Immersive Therapy

UNKNOWN

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alain Londero, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital européen Georges-Pompidou AP-HP

Paris, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 26773752 (View on PubMed)

Other Identifiers

2021-A01045-36

Identifier Type: REGISTRY

Identifier Source: secondary_id

APHP210808

Identifier Type: -

Identifier Source: org_study_id