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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04987502
Other study ID # APHP210808
Secondary ID 2021-A01045-36
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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