TinnitusReVA2NCT04987502
Virtual Reality and Subjective Tinnitus
A study testing Virtual Reality and Standard treatment in people with Tinnitus and Tinnitus, Subjective, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tinnitus, Tinnitus, Subjective
- What is being tested?
- Virtual Reality and Standard treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 7 Sep 2022to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Tinnitus, Tinnitus, Subjective
- Being tested
- Virtual Reality, Standard treatment
- Keywords
- Subjective tinnitus, Virtual Reality, Cognitive Behavioral Therapy
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityOther
8 sessions of virtual reality with 3D audio and visual rendering
Standard treatmentBehavioural
counselling, relaxation techniques, sound enrichment
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality treatment | Experimental | Virtual reality immersion with 3D audio and visual rendering (8 weekly sessions) Receives: Other: Virtual Reality |
| Standard treatment | Active comparator | Counselling Relaxation techniques Sound enrichment Receives: Behavioral: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Tinnitus Severity Scale (S.T.S.S.)
16 items multidimensional questionnaire (validated in French) Score 0 to 16 (maximum severity)
Measured: 5 months
Secondary outcomes (4)
Tinnitus Handicap Questionnaire (THI)
25 items multidimensional questionnaire (validated in French) Score 0 to 100 (maximum handicap)
Measured: 5 months
Hospital Anxiety Depression Scale
14 item questionnaire (validated in French) Score 0 to 21 (maximum anxiety) Score 0 to 21 (maximum depression)
Measured: 5 months
Visual Analog Scale Tinnitus Loudness
Likert-Scale 0 to 10 (maximum loudness)
Measured: 5 months
Visual Analog Scale Tinnitus Intrusiveness
Likert-Scale 0 to 10 (maximum intrusiveness)
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start7 Sep 2022
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de recherche et de coordination acoustique/musique, Institut National de la Santé Et de la Recherche Médicale, France, Immersive Therapy
- Responsible party
- Sponsor
- Investigators
- Alain Londero, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987502
- Sponsor's protocol ID
- APHP210808
- Other IDs
- 2021-A01045-36
- Acronym
- ReVA2
- Status last verified
- Feb 2025
- First submitted
- 31 Jul 2021
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Publications
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.
PubMed 26773752
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality and Subjective Tinnitus
- ClinicalTrials.gov ID
- NCT04987502
- Acronym / sponsor ID
- ReVA2 / APHP210808
- Conditions
- Tinnitus, Tinnitus, Subjective
- Keywords
- Subjective tinnitus, Virtual Reality, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut de recherche et de coordination acoustique/musique, Institut National de la Santé Et de la Recherche Médicale, France, Immersive Therapy
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality treatment | Experimental | Other: Virtual RealityVirtual reality immersion with 3D audio and visual rendering (8 weekly sessions) |
| Standard treatment | Active comparator | Behavioral: Standard treatmentCounselling Relaxation techniques Sound enrichment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality8 sessions of virtual reality with 3D audio and visual rendering | Other | Virtual reality treatment |
| Standard treatmentcounselling, relaxation techniques, sound enrichment | Behavioural | Standard treatment |
Primary outcome
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)
4 secondary outcomes
Tinnitus Handicap Questionnaire (THI)
Time frame: 5 months
Hospital Anxiety Depression Scale
Time frame: 5 months
Visual Analog Scale Tinnitus Loudness
Time frame: 5 months
Visual Analog Scale Tinnitus Intrusiveness
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Background: PubMed 26773752Malinvaud 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.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain Londero, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality and Standard treatment in people with Tinnitus and Tinnitus, Subjective, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Tinnitus Severity Scale (S.T.S.S.) (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04987502, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.