NCT04987502

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 3, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 7, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

February 18, 2025

Status Verified

February 1, 2025

Enrollment Period

1.7 years

First QC Date

July 31, 2021

Last Update Submit

February 14, 2025

Conditions

TinnitusTinnitus, Subjective

Keywords

Subjective tinnitusVirtual RealityCognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

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

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

    5 months

Secondary Outcomes (4)

  • Tinnitus Handicap Questionnaire (THI)

    5 months

  • Hospital Anxiety Depression Scale

    5 months

  • Visual Analog Scale Tinnitus Loudness

    5 months

  • Visual Analog Scale Tinnitus Intrusiveness

    5 months

Study Arms (2)

Virtual reality treatment

EXPERIMENTAL

Virtual reality immersion with 3D audio and visual rendering (8 weekly sessions)

Other: Virtual Reality

Standard treatment

ACTIVE COMPARATOR

Counselling Relaxation techniques Sound enrichment

Behavioral: Standard treatment

Interventions

Virtual RealityOTHER

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

Virtual reality treatment
Standard treatmentBEHAVIORAL

counselling, relaxation techniques, sound enrichment

Standard treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital européen Georges-Pompidou AP-HP

Paris, 75015, France

Location

Related 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.

    PMID: 26773752BACKGROUND

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alain Londero, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2021

First Posted

August 3, 2021

Study Start

September 7, 2022

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

February 18, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Two years after the last publication
Access Criteria
Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. Data sharing must respect the agreements made with funders. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement. Processing of shared data must comply with European General Data Protection Regulation (GDPR).

Locations

FR(1)