Clinical trial NCT04987502: Virtual Reality and Subjective Tinnitus
Official title: Virtual Reality and Subjective Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Tinnitus, Subjective
Keywords: Subjective tinnitus
Virtual Reality
Cognitive Behavioral Therapy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut de recherche et de coordination acoustique/musique
name: Institut National de la Santé Et de la Recherche Médicale, France
name: Immersive Therapy
First posted: 2021-08-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Subjective Tinnitus Severity Scale (S.T.S.S.)
timeFrame: 5 months
Secondary outcomes:
measure: Tinnitus Handicap Questionnaire (THI)
timeFrame: 5 months
measure: Hospital Anxiety Depression Scale
timeFrame: 5 months
measure: Visual Analog Scale Tinnitus Loudness
timeFrame: 5 months
measure: Visual Analog Scale Tinnitus Intrusiveness
timeFrame: 5 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital européen Georges-Pompidou AP-HP
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Alain Londero, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.