Status:
RECRUITING
Cochlear Implanted Listening Effort and Hearing Attention
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Sensorineural Hearing Loss
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Cochlear implant users perceive mainly sound amplitude modulation cues. Processing of these amplitude modulations can be subject to interferences, so that the perception of a modulation in a target so...
Detailed Description
Participants to this trial will be adult patients with cochlear implants (experimental group) and adults with normal-for-the-age hearing (healthy volunteers or controls), recruited in a single center ...
Eligibility Criteria
Inclusion
- Arm 1: patient with Cochlear Implant
- Having a unilateral Oticon Medical cochlear implant
- Duration of use of the implant of 6 months or more
- Disyllabic word recognition score of at least 40% on average in silence, to limit "floor" effects in hearing tests.
- Disyllabic word recognition score not exceeding 30% on the contra-lateral ear alone, aided or not, in silence.
- Arm 2: volunteers with normal hearing
- \- Normal tonal audiometry for the age
- For both
- Age between 18 and 80 years old
- Mother tongue : French
- Normal vision with or without correction
- Absence of eye pathologies (cataracts, nystagmus, amblyopia, macular degeneration).
- Not taking psychotropic drugs or drugs affecting the parasympathetic nervous system
- Absence of pathology or neurological history (especially head trauma, stroke).
- Information and signing of a consent prior to any act related to research
Exclusion
- For both groups, ensuring the reliability of the pupillometric measurement (Winn et al., 2018):
- Pathologies of the eye: cataracts, nystagmus, amblyopia, macular degeneration.
- Taking psychotropic drugs and / or drugs affecting the parasympathetic nervous system
- Neurological pathology (in particular head trauma or stroke) associated with an alteration of cognitive functions or history thereof that may affect the stability of the gaze, the congruence of eye movements, pupillary dilation or with an alteration of cognitive functions
- Others criteria:
- No affiliation (or being entitled) to a social security scheme
- Person under State Medical Assistance
- Person under legal protection (tutorship, curatorship, other…) or under family authorization
Key Trial Info
Start Date :
December 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 22 2026
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT04733950
Start Date
December 8 2021
End Date
February 22 2026
Last Update
January 13 2025
Active Locations (1)
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1
Assistance Publique-Hôpitaux de Paris
Paris, France, 75013