Evaluating Listening Effort in Cochlear Implant Users

Role of Selective Attention for Sound Modulations in the Listening Effort of Patients With Cochlear Implants

This study tests how well adults with cochlear implants can focus on sounds compared to people with normal hearing to see what makes listening harder for them in busy environments.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 170 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (other)
• Locations: 1 site (Paris)
• Trial ID: NCT04733950 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 80 with a unilateral Oticon Medical cochlear implant and a minimum of 6 months of usage.

Not a fit: Patients with significant neurological history or those taking psychotropic medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved strategies for enhancing auditory processing and reducing listening effort in cochlear implant users.

How similar studies have performed: Other studies have explored auditory attention in cochlear implant users, suggesting that this approach has potential but may still be novel in its specific focus on listening effort.

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

Where this trial is running

Paris

• 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

Conditions: Sensorineural Hearing Loss, Cochlear implant, Listening effort, Auditory attention, Pupil dilatation, Sound Modulation