Virtual Reality and Subjective Tinnitus

Study Overview
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Brief Summary
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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
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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.

Official Title
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Virtual Reality and Subjective Tinnitus

Conditions
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Tinnitus, Tinnitus, Subjective

Intervention / Treatment
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* Other: Virtual Reality
* Behavioral: Standard treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Tinnitus Severity Scale (S.T.S.S.) | 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) | 25 items multidimensional questionnaire (validated in French) Score 0 to 100 (maximum handicap) | 5 months | 
| Hospital Anxiety Depression Scale | 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 | Likert-Scale 0 to 10 (maximum loudness) | 5 months | 
| Visual Analog Scale Tinnitus Intrusiveness | Likert-Scale 0 to 10 (maximum intrusiveness) | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subjective tinnitus, Virtual Reality, Cognitive Behavioral Therapy