Tinnitus Clinical Trial
— ReVA2Official title:
Virtual Reality and Subjective Tinnitus
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital européen Georges-Pompidou AP-HP | Paris |
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 |
France,
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
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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