Hôpital européen Georges-Pompidou AP-HP
Paris, 75015, France
NCT Number: NCT04987502
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.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Paris, 75015, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
8 sessions of virtual reality with 3D audio and visual rendering
counselling, relaxation techniques, sound enrichment
Time frame: 5 months
16 items multidimensional questionnaire (validated in French) Score 0 to 16 (maximum severity)
Time frame: 5 months
25 items multidimensional questionnaire (validated in French) Score 0 to 100 (maximum handicap)
Time frame: 5 months
14 item questionnaire (validated in French) Score 0 to 21 (maximum anxiety) Score 0 to 21 (maximum depression)
Time frame: 5 months
Likert-Scale 0 to 10 (maximum loudness)
Time frame: 5 months
Likert-Scale 0 to 10 (maximum intrusiveness)
Assistance Publique - Hôpitaux de Paris
Other
Acronym: ReVA2
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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