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

NCT06940726 | Not Yet Recruiting

• 2 other identifiers: 2024-1592025-A00267-42
• Study Type: interventional
• Target: 114
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Tinnitus

Keywords

tinnitus

Outcome Measures

Primary Outcomes (1)

• Contingent negative variation (CNV) in EEG

  2 hours

Secondary Outcomes (6)

• Response reaction time (in ms)

  2 hours

• Answer accuracy (% correct answers)

  2 hours

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

  2 hours

• Skin conductance (μS)

  2 hours

• Heart rate variability (in ms)

  2 hours

Study Arms (2)

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

Interventions

Quality of Life questionnaires OTHER

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

Healthy subjects; Subjets with tinnitus

Hearing tests OTHER

listening to sounds on headphones and repeating words

Healthy subjects; Subjets with tinnitus

Auditory prediction task BEHAVIORAL

listening to sounds and assessing auditory perception

Healthy subjects; Subjets with tinnitus

Attention task BEHAVIORAL

assessment of reaction time to visual or auditory cues

Healthy subjects; Subjets with tinnitus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Pasteur: lead
• IHU reConnect: collaborator

MeSH Terms

Conditions

Tinnitus

Interventions

Hearing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Vestibulocochlear Physiological Phenomena; Physiological Phenomena; Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Séverine Samson

CONTACT

+33 (0)1 76 53 51 44; severine.samson@pasteur.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 23, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: April 23, 2025

Record last verified: 2025-03