Exploring the Links Between Hearing, Cognition and Brain Activity in People With Tinnitus (GHOSTTONE)

April 15, 2025 updated by: Institut Pasteur

Exploration Des Liens Entre Audition, Cognition et activité cérébrale Chez Des Personnes présentant un acouphène

The goal of this observational study is to understand the mechanisms underlying tinnitus, and improve the clinical assessment strategies needed to develop targeted therapeutic interventions by comparing endogenous attention capacities in healthy subjects and subjects with tinnitus

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Good written and oral comprehension of the French language
  • Normal or corrected vision

Group of people with tinnitus :

- Chronic tinnitus > 3 months, uni or bilateral, stable (no period of remission)

Control group :

- No tinnitus

Exclusion Criteria:

  • Presence of a known neurological disorder
  • Presence of a known degenerative pathology
  • Presence of a known hearing impairment
  • Presence of a motor disability of the upper limbs
  • Severe or profound deafness on one or both sides
  • Person under legal protection (guardianship, curatorship, etc.)
  • Use of hearing aids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Healthy subjects
Other: Quality of Life questionnaires
Subjects will complete a number of self-questionnaires on subjects such as attention span, anxiety levels and sleep quality.
Other: Hearing tests
listening to sounds on headphones and repeating words
Behavioral: Auditory prediction task
listening to sounds and assessing auditory perception
Behavioral: Attention task
assessment of reaction time to visual or auditory cues
Experimental: Subjets with tinnitus
Other: Quality of Life questionnaires
Subjects will complete a number of self-questionnaires on subjects such as attention span, anxiety levels and sleep quality.
Other: Hearing tests
listening to sounds on headphones and repeating words
Behavioral: Auditory prediction task
listening to sounds and assessing auditory perception
Behavioral: Attention task
assessment of reaction time to visual or auditory cues

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Contingent negative variation (CNV) in EEG
Time Frame: 2 hours
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response reaction time (in ms)
Time Frame: 2 hours
Comparison of reaction time (RT) variability following response button presses in behavioural tasks
2 hours
Answer accuracy (% correct answers)
Time Frame: 2 hours
Comparison of the variability of the number of correct responses following button presses in behavioural tasks.
2 hours
Cerebral oscillations (alpha bands) obtained by EEG during behavioural tasks
Time Frame: 2 hours
2 hours
Skin conductance (μS)
Time Frame: 2 hours
during behavioral task
2 hours
Heart rate variability (in ms)
Time Frame: 2 hours
during behavioral task
2 hours
Pupillometry (pupillary dilation in mm)
Time Frame: 2 hours
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Pasteur

Collaborators

IHU reConnect

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

April 8, 2025

First Submitted That Met QC Criteria

April 15, 2025

First Posted (Actual)

April 23, 2025

Study Record Updates

Last Update Posted (Actual)

April 23, 2025

Last Update Submitted That Met QC Criteria

April 15, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-159
  • 2025-A00267-42 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tinnitus

Clinical Trials on Quality of Life questionnaires

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe