Virtual Reality and Subjective Tinnitus (ReVA2)

April 14, 2023 updated by: Assistance Publique - Hôpitaux de Paris
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual reality treatment
Virtual reality immersion with 3D audio and visual rendering (8 weekly sessions)
Other: Virtual Reality
8 sessions of virtual reality with 3D audio and visual rendering
Active Comparator: Standard treatment
Counselling Relaxation techniques Sound enrichment
Behavioral: Standard treatment
counselling, relaxation techniques, sound enrichment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Tinnitus Severity Scale (S.T.S.S.)
Time Frame: 5 months
16 items multidimensional questionnaire (validated in French) Score 0 to 16 (maximum severity)
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tinnitus Handicap Questionnaire (THI)
Time Frame: 5 months
25 items multidimensional questionnaire (validated in French) Score 0 to 100 (maximum handicap)
5 months
Hospital Anxiety Depression Scale
Time Frame: 5 months
14 item questionnaire (validated in French) Score 0 to 21 (maximum anxiety) Score 0 to 21 (maximum depression)
5 months
Visual Analog Scale Tinnitus Loudness
Time Frame: 5 months
Likert-Scale 0 to 10 (maximum loudness)
5 months
Visual Analog Scale Tinnitus Intrusiveness
Time Frame: 5 months
Likert-Scale 0 to 10 (maximum intrusiveness)
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

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

Investigators

  • Principal Investigator: Alain Londero, MD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2022

Primary Completion (Anticipated)

April 7, 2024

Study Completion (Anticipated)

April 7, 2024

Study Registration Dates

First Submitted

July 31, 2021

First Submitted That Met QC Criteria

July 31, 2021

First Posted (Actual)

August 3, 2021

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP210808
  • 2021-A01045-36 (Registry Identifier: ID-RCB Number - ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

Two years after the last publication

IPD Sharing Access Criteria

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).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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