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Completed

NCT Number: NCT04987502

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital européen Georges-Pompidou AP-HP

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality

Other

8 sessions of virtual reality with 3D audio and visual rendering

Standard treatment

Behavioral

counselling, relaxation techniques, sound enrichment

Primary outcomes

  1. Subjective Tinnitus Severity Scale (S.T.S.S.)

    Time frame: 5 months

    16 items multidimensional questionnaire (validated in French) Score 0 to 16 (maximum severity)

Secondary outcomes

  1. Tinnitus Handicap Questionnaire (THI)

    Time frame: 5 months

    25 items multidimensional questionnaire (validated in French) Score 0 to 100 (maximum handicap)

  2. Hospital Anxiety Depression Scale

    Time frame: 5 months

    14 item questionnaire (validated in French) Score 0 to 21 (maximum anxiety) Score 0 to 21 (maximum depression)

  3. Visual Analog Scale Tinnitus Loudness

    Time frame: 5 months

    Likert-Scale 0 to 10 (maximum loudness)

  4. Visual Analog Scale Tinnitus Intrusiveness

    Time frame: 5 months

    Likert-Scale 0 to 10 (maximum intrusiveness)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Immersive Therapy
  • Institut National de la Santé Et de la Recherche Médicale, France
  • Institut de recherche et de coordination acoustique/musique

Registry information

Acronym: ReVA2

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 3, 2021
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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