Evaluating Listening Effort in Cochlear Implant Users

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates how selective auditory attention affects listening effort in adults with cochlear implants compared to healthy volunteers with normal hearing. Participants will undergo a psychoacoustic task to assess their ability to detect sound modulations while their pupil diameter is measured to evaluate listening effort. The study aims to understand the challenges cochlear implant users face in complex auditory environments, such as conversations with multiple speakers. Data will be collected in a single session at a specialized center in Paris.

Why it matters

Who can join: the full rules

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

Where it's running

• Assistance Publique-Hôpitaux de Paris
  Paris, France Recruiting

Study contacts

• Principal investigator: Isabelle MOSNIER, MD — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Isabelle MOSNIER, MD
• Email: isabelle.mosnier@aphp.fr
• Phone: +33 1 42 16 26 06

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.