Cochlear Implanted Listening Effort and Hearing Attention
EffICAtt
Role of Selective Attention for Sound Modulations in the Listening Effort of Patients With Cochlear Implants
1 other identifier
interventional
170
1 country
1
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 sound can be impaired by a superimposed sound if this sound contains a similar modulation. Such phenomenon, which is observed both in subjects with normal-hearing and in cochlear-implant users, could be explained by difficulties to direct attention to relevant information in complex sound signals. Selective auditory attention also plays a crucial role in speech comprehension in cocktail-party situations where the speech of multiple talkers get mixed at the ear of a listener. Cochlear implant users typically struggle in these cocktail-party situations and report intense listening effort. The present clinical trial aims at evaluating the contribution of selective auditory attention for sound modulations to the listening effort of patients with cochlear implants and of healthy volunteers with normal-hearing during speech perception under cocktail-party-like conditions. Selective auditory attention abilities of patients and controls will be assessed using a psychoacoustical test whereby their ability to detect a target sound amplitude modulation will be measured both in the absence and in the presence of an interfering (i.e. distracting) amplitude modulation occurring in a distant spectral region from that of the target. The effect of this distractor's presence on modulation detection performance will serve as a behavioural index of the subject's auditory attention capacities. The attentional capacity index will then be tested as a predicting factor for the listening effort of the subject during a speech-in-noise consonant identification task. Listening effort will be measured from the pupil dilation response to the presented speech units (pseudowords). This study will enhance our understanding of cochlear implant user's perception and listening effort and will serve as a basis for prognostic tests of listening effort and of implantation success for cochlear implant candidates, based on a simple measurement of auditory attentional abilities.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2021
CompletedFirst Posted
Study publicly available on registry
February 2, 2021
CompletedStudy Start
First participant enrolled
December 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 22, 2026
CompletedJanuary 13, 2025
January 1, 2025
4.2 years
January 24, 2021
January 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Contribution of selective auditory attention recruitment to listening effort during speech perception in interfering noise
Statistical correlation between * the effect of a distractor on the performance of patients in a sound modulation detection task, and * the effect of introducing interfering noise on an objective measure of the listening effort of these same patients (pupillary response) while performing a speech identification task
at study inclusions completion, 18 months after firsth enrollment
Secondary Outcomes (3)
The listening effort during speech identification in the presence of another interfering speech
Day one
The link between difficulty, performance and effort during modulation detection
Day one
Comparison between the two arms (patients with cochlear implant and volunteers with normal hearing) of the assessments of performances and listening effort.
Day one
Study Arms (2)
Patients with cochlear implant
EXPERIMENTALPatients with cochlear implant for 6 months and more
Healthy volunteers (normal hearing)
ACTIVE COMPARATORHealthy volunteers with a normal tonal audiometry for age
Interventions
Description: 3-interval, 3-alternative forced choice amplitude modulation detection task using a target sinusoidal carrier and a spectrally distant, interfering (distracting), sinusoidal carrier that may or not be modulated at the same rate as the target.
Pupil diameter is recorded using an eye-tracker device (Tobii Pro TX300) while the subject performs a 16-alternative consonant identification task both in silence and in the presence of interfering speech.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assistance Publique-Hôpitaux de Paris
Paris, 75013, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Isabelle MOSNIER, MD
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2021
First Posted
February 2, 2021
Study Start
December 8, 2021
Primary Completion
February 22, 2026
Study Completion
February 22, 2026
Last Updated
January 13, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share