NCT06940726Not yet recruitingNot Applicable
Exploration Des Liens Entre Audition, Cognition et activité cérébrale Chez Des Personnes présentant un acouphène
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Institut Pasteur
- Enrollment
- 114
- Primary Endpoint
- Contingent negative variation (CNV) in EEG
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Healthy subjects
Sham Comparator
Intervention: Attention task (Behavioral)
Healthy subjects
Sham Comparator
Intervention: Quality of Life questionnaires (Other)
Healthy subjects
Sham Comparator
Intervention: Hearing tests (Other)
Healthy subjects
Sham Comparator
Intervention: Auditory prediction task (Behavioral)
Subjets with tinnitus
Experimental
Intervention: Quality of Life questionnaires (Other)
Subjets with tinnitus
Experimental
Intervention: Hearing tests (Other)
Subjets with tinnitus
Experimental
Intervention: Auditory prediction task (Behavioral)
Subjets with tinnitus
Experimental
Intervention: Attention task (Behavioral)
Outcomes
Primary Outcomes
Contingent negative variation (CNV) in EEG
Time Frame: 2 hours
Secondary Outcomes
- Skin conductance (μS)(2 hours)
- 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)
- Heart rate variability (in ms)(2 hours)
- Pupillometry (pupillary dilation in mm)(2 hours)
Investigators
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