TinnitusGHOSTTONENCT06940726
Exploring the Links Between Hearing, Cognition and Brain Activity in People With Tinnitus
A study testing Quality of Life questionnaires, Hearing tests and Auditory prediction task in people with Tinnitus, run by Institut Pasteur.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tinnitus
- What is being tested?
- Quality of Life questionnaires, Hearing tests and Auditory prediction task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
- Conditions
- Tinnitus
- Being tested
- Quality of Life questionnaires, Hearing tests, Auditory prediction task, Attention task
- Keywords
- tinnitus
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of Life questionnairesOther
Subjects will complete a number of self-questionnaires on subjects such as attention span, anxiety levels and sleep quality.
Hearing testsOther
listening to sounds on headphones and repeating words
Auditory prediction taskBehavioural
listening to sounds and assessing auditory perception
Attention taskBehavioural
assessment of reaction time to visual or auditory cues
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Sham comparator | Not described Receives: Other: Quality of Life questionnaires; Other: Hearing tests; Behavioral: Auditory prediction task; Behavioral: Attention task |
| Subjets with tinnitus | Experimental | Not described Receives: Other: Quality of Life questionnaires; Other: Hearing tests; Behavioral: Auditory prediction task; Behavioral: Attention task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contingent negative variation (CNV) in EEG
Measured: 2 hours
Secondary outcomes (6)
Response reaction time (in ms)
Comparison of reaction time (RT) variability following response button presses in behavioural tasks
Measured: 2 hours
Answer accuracy (% correct answers)
Comparison of the variability of the number of correct responses following button presses in behavioural tasks.
Measured: 2 hours
Cerebral oscillations (alpha bands) obtained by EEG during behavioural tasks
Measured: 2 hours
Skin conductance (μS)
during behavioral task
Measured: 2 hours
Heart rate variability (in ms)
during behavioral task
Measured: 2 hours
Pupillometry (pupillary dilation in mm)
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study startMay 2025 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IHU reConnect
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940726
- Sponsor's protocol ID
- 2024-159
- Other IDs
- 2025-A00267-42
- Acronym
- GHOSTTONE
- Status last verified
- Mar 2025
- First submitted
- 8 Apr 2025
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration Des Liens Entre Audition, Cognition et activité cérébrale Chez Des Personnes présentant un acouphène
- ClinicalTrials.gov ID
- NCT06940726
- Acronym / sponsor ID
- GHOSTTONE / 2024-159
- Conditions
- Tinnitus
- Keywords
- tinnitus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- IHU reConnect
- Study start
- May 2025 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 23 Apr 2025 (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 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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Sham comparator | Other: Quality of Life questionnaires, Other: Hearing tests, Behavioral: Auditory prediction task, Behavioral: Attention task |
| Subjets with tinnitus | Experimental | Other: Quality of Life questionnaires, Other: Hearing tests, Behavioral: Auditory prediction task, Behavioral: Attention task |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Good written and oral comprehension of the French language
- Normal or corrected vision
- Chronic tinnitus > 3 months, uni or bilateral, stable (no period of remission)
- No tinnitus
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Quality of Life questionnairesSubjects will complete a number of self-questionnaires on subjects such as attention span, anxiety levels and sleep quality. | Other | Healthy subjects, Subjets with tinnitus |
| Hearing testslistening to sounds on headphones and repeating words | Other | Healthy subjects, Subjets with tinnitus |
| Auditory prediction tasklistening to sounds and assessing auditory perception | Behavioural | Healthy subjects, Subjets with tinnitus |
| Attention taskassessment of reaction time to visual or auditory cues | Behavioural | Healthy subjects, Subjets with tinnitus |
Primary outcome
Contingent negative variation (CNV) in EEG
Time frame: 2 hours
6 secondary outcomes
Response reaction time (in ms)
Time frame: 2 hours
Answer accuracy (% correct answers)
Time frame: 2 hours
Cerebral oscillations (alpha bands) obtained by EEG during behavioural tasks
Time frame: 2 hours
Skin conductance (μS)
Time frame: 2 hours
Heart rate variability (in ms)
Time frame: 2 hours
Pupillometry (pupillary dilation in mm)
Time frame: 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Tinnitus
Active, not recruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus
Recruiting
Deep Repetitive Transcranial Magnetic Stimulation in the Treatment of Tinnitus
Tinnitus, Tinnitus, Bilateral
Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
Tinnitus, Chronic Subjective Tinnitus
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.
Questions about this trial
What is this clinical trial studying?
A study testing Quality of Life questionnaires, Hearing tests and Auditory prediction task in people with Tinnitus, run by Institut Pasteur.
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 7 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: opening soon, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Séverine Samson (+33 (0)1 76 53 51 44, severine.samson@pasteur.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contingent negative variation (CNV) in EEG (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2025.