Virtual Reality and Subjective Tinnitus

Tinnitus Clinical Trial

— ReVA2  

Official title:

Virtual Reality and Subjective Tinnitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04987502
• Other study ID #: APHP210808
• Secondary ID: 2021-A01045-36
• Status: Recruiting
• Phase: N/A
• Start date: September 7, 2022
• Est. completion date: April 7, 2024

Study information

• Verified date: April 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Natacha Nohilé
• Phone: 3356095982
• Email: natacha.nohile[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 7, 2024
• Est. primary completion date: April 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Tinnitus
• Tinnitus, Subjective

Intervention

Other:
• Virtual Reality
8 sessions of virtual reality with 3D audio and visual rendering

Behavioral:
• Standard treatment
counselling, relaxation techniques, sound enrichment

Locations

Country	Name	City	State
France	Hôpital européen Georges-Pompidou AP-HP	Paris

Sponsors (4)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Immersive Therapy, Institut de recherche et de coordination acoustique/musique, Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective Tinnitus Severity Scale (S.T.S.S.)	16 items multidimensional questionnaire (validated in French) Score 0 to 16 (maximum severity)	5 months
Secondary	Tinnitus Handicap Questionnaire (THI)	25 items multidimensional questionnaire (validated in French) Score 0 to 100 (maximum handicap)	5 months
Secondary	Hospital Anxiety Depression Scale	14 item questionnaire (validated in French) Score 0 to 21 (maximum anxiety) Score 0 to 21 (maximum depression)	5 months
Secondary	Visual Analog Scale Tinnitus Loudness	Likert-Scale 0 to 10 (maximum loudness)	5 months
Secondary	Visual Analog Scale Tinnitus Intrusiveness	Likert-Scale 0 to 10 (maximum intrusiveness)	5 months