NCT04733950 Cochlear Implanted Listening Effort and Hearing Attention
| NCT ID | NCT04733950 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Sensorineural Hearing Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 170 participants |
| Start Date | 2021-12-08 |
| Primary Completion | 2026-02-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 170 participants in total. It began in 2021-12-08 with a primary completion date of 2026-02-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Isabelle MOSNIER, MD
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT04733950 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Sensorineural Hearing Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04733950 currently recruiting?
Yes, NCT04733950 is actively recruiting participants. Contact the research team at isabelle.mosnier@aphp.fr for enrollment information.
Where is the NCT04733950 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT04733950 clinical trial?
NCT04733950 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Isabelle MOSNIER, MD at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 170 participants.