Cochlear Implanted Listening Effort and Hearing Attention
ConditionSensorineural Hearing Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
No affiliation (or being entitled) to a social security scheme
Trial design
Design model
Factorial
Treatments tested in this trial
Forced choice psychoacoustic task for the evaluation of modulation detection performance and selective auditory attention. (for both arm)
Other interventionDescription: 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.
Measurement of the pupil diameter for the evaluation of listening effort during speech perception
Other interventionPupil 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.
Treatment groups
170 Participants
are divided into 2 treatment groupsGroup A: Patients with cochlear implantExperimental treatment 2 interventions
Group B: Healthy volunteers (normal hearing)Active comparator 2 interventions
Trial outcomes
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
Time frame
at study inclusions completion, 18 months after firsth enrollmentSecondary outcomes
1
The listening effort during speech identification in the presence of another interfering speech
this effort will be assessed by the mean pupillary response; its variability in the population will be measured by statistics for the entire sample (standard deviation and percentiles).
Time frame
Day one2
The link between difficulty, performance and effort during modulation detection
This link will be modeled by a set of parametric functions linking these variables two by two (constant function, linear function, polynomial function, etc.)…; models will be fitted by the method of least squares and the selection of the best model will be made on the basis of the least residual for models with equal degrees of freedom, on the basis of a Fisher test for models with different degrees of freedom.
Time frame
Day one3
Comparison between the two arms (patients with cochlear implant and volunteers with normal hearing) of the assessments of performances and listening effort.
this comparison will be done by Student's parametric tests, after checking the normality of the distributions. In case of non-normality of the distributions, one will have recourse to tests of permutations. The significance level will be set at a p value of 0.05.
Time frame
Day oneSponsors and contacts
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Source ClinicalTrials.gov