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NCT Number: NCT06940726

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

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

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Key information

Conditions

Tinnitus Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Quality of life questionnaires

Other

Subjects will complete a number of self-questionnaires on subjects such as attention span, anxiety levels and sleep quality.

Hearing tests

Other

listening to sounds on headphones and repeating words

Auditory prediction task

Behavioral

listening to sounds and assessing auditory perception

Attention task

Behavioral

assessment of reaction time to visual or auditory cues

Primary outcomes

  1. Contingent negative variation (CNV) in EEG

    Time frame: 2 hours

Secondary outcomes

  1. Response reaction time (in ms)

    Time frame: 2 hours

    Comparison of reaction time (RT) variability following response button presses in behavioural tasks

  2. Answer accuracy (% correct answers)

    Time frame: 2 hours

    Comparison of the variability of the number of correct responses following button presses in behavioural tasks.

  3. Cerebral oscillations (alpha bands) obtained by EEG during behavioural tasks

    Time frame: 2 hours

  4. Skin conductance (μS)

    Time frame: 2 hours

    during behavioral task

  5. Heart rate variability (in ms)

    Time frame: 2 hours

    during behavioral task

  6. Pupillometry (pupillary dilation in mm)

    Time frame: 2 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Séverine Samson

CONTACT

[email protected]

+33 (0)1 76 53 51 44

Sponsors and collaborators

Lead sponsor

Institut Pasteur

Industry

Collaborators

  • IHU reConnect

Registry information

Official study title

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

Acronym: GHOSTTONE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 23, 2025
Registry last updated
Apr 23, 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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