Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:13 PM
Ignite Modification Date:
2025-12-24 @ 5:13 PM
NCT ID:
NCT04733950
Eligibility Criteria:
Inclusion Criteria:
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 Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04733950
Study Brief:
Protocol Section:
NCT04733950