| Registry | NCT07500909, acronym REASCENT |
|---|---|
| Status | Not yet recruiting |
| Study type | Observational |
| Enrollment | 90 (Estimated) |
| Sponsor | University Hospital, Toulouse (Other); collaborators: Centre de recherche Cerveau et Cognition (CERCO) |
| Conditions | Deafness, Bilateral |
| Interventions | neurophysiological assessment, Cognitive, behavioral and quality of life assessment (Other, behavioral) |
| Dates | start 2026-03-01 (estimated), primary completion 2029-03-01 (estimated), completion 2029-03-01 (estimated), first posted 2026-03-30, last updated 2026-03-30 |
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All trials for Deafness, Bilateral All trials of neurophysiological assessment All trials of Cognitive, behavioral and quality of life assessment
This study posits that central top-down processes (attention, inhibition), marked by alpha oscillations in EEG, play a key role. Understanding the evolution of these neuronal signatures and their link to pre-implantation visual dependence could allow the identification of biomarkers predictive of the success of auditory rehabilitation.
Profound bilateral deafness leads to sensory deprivation and neuronal reorganization ( visual recruitment of the auditory cortex). Although cochlear implants restore hearing, comprehension performance varies considerably. Peripheral factors explain only 40% of this variance. This study posits that central top-down processes (attention, inhibition), marked by alpha oscillations in EEG, play a key role. Understanding the evolution of these neuronal signatures and their link to pre-implantation visual dependence could allow the identification of biomarkers predictive of the success of auditory rehabilitation.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Group of cochlear implant patients | Other: neurophysiological assessment; Behavioral: Cognitive, behavioral and quality of life assessment | This group consists of adult patients with profound bilateral hearing loss, candidates for a first unilateral cochlear implant, and meeting the specific inclusion criteria. | |
| Group of young, normally hearing subjects | Other: neurophysiological assessment; Behavioral: Cognitive, behavioral and quality of life assessment | This control group consists of healthy young adult subjects (18-40 years old) with normal and symmetrical hearing confirmed by audiometry. | |
| Group of normally hearing elderly subjects matched for gender and age | Other: neurophysiological assessment; Behavioral: Cognitive, behavioral and quality of life assessment | This control group consists of healthy older adults (> 50 years) with age-appropriate hearing (thresholds defined in the inclusion criteria) confirmed by audiometry. They are matched by age (+/- 2 years) and gender with the cochlear implant patient group. | |
| Group of experienced cochlear implant patients | Other: neurophysiological assessment; Behavioral: Cognitive, behavioral and quality of life assessment | This control group consists of adult patients using a unilateral cochlear implant for at least one year and exhibiting good hearing performance (≥70% word recognition). | |
| Group of hearing-equipped deaf patients | Other: neurophysiological assessment; Behavioral: Cognitive, behavioral and quality of life assessment | This control group consists of adult patients with severe bilateral deafness who have been rehabilitated with optimally fitted hearing aids. |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
Inclusion Criteria: For cochlear implant patients: * Adult patients * Profound bilateral hearing loss requiring a first cochlear implant * Normal cochlear anatomy (confirmed by preoperative imaging) * Full insertion of the cochlear electrode array planned * Acceptance of the protocol and signing of the informed consent form * Enrollment in a social security or equivalent plan For young patients with normal hearing: * Adult patients aged 18 to 40 * Normal and symmetrical hearing * Acceptance of the protocol and signature of the informed consent form * Affiliation with a social security scheme or equivalent For older patients with normal hearing: * Patients over 50 years of age, matched by gender and age (+/- 2 years) with the cochlear implant patient group * Normal and symmetrical hearing, with hearing thresholds < 20 dB HL at 2 kHz and < 40 dB HL at 4 kHz * Acceptance of the protocol and signature of the informed consent form * Affiliation with a social security scheme or equivalent For experienced cochlear implant recipients: * Adult patients. * Unilateral cochlear implant activated for 1 year or more. * Disyllabic word recognition score at 60 dB in free field of 70% or higher. * Acceptance of the protocol and signature of the informed consent form. * Affiliation with a social security plan or equivalent. For severely deaf patients fitted with hearing aids: * Adult patients. * Severe bilateral hearing loss. * Rehabilitation with one or two optimally fitted hearing aids. * Acceptance of the protocol and signing of the informed consent form. * Enrollment in a social security or equivalent health insurance plan. Exclusion Criteria: * History of associated neurological pathology * Etiologies with unfavorable prognoses, such as recurrent chronic otitis media: These conditions are associated with a poor prognosis due to chronic inflammation that can affect the cochlea * Duration of profound bilateral deafness exceeding 5 years (worse prognosis) * Contraindications to EEG or other neurophysiological examinations within the study (for all groups) * Cognitive impairment confirmed by the MOCA test for the cochlear implant patient group and the group of elderly subjects with normal hearing * Use of psychotropic medications that may interfere with the results of cognitive or neurological tests * History of epilepsy or other major neurological disorders * Pregnancy or breastfeeding * Participation in another interventional research protocol or one that impacts the criteria studied in this project * Individuals under legal guardianship (guardianship, tutorship, curatorship, institutionalized, or under a future protection mandate)