[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100418840":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":44,"responsibleParty":60,"collaborators":25,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":25,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":47,"whyStopped":25,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with cochlear implant","EXPERIMENTAL","Patients with cochlear implant for 6 months and more",[13,14],"Other: Forced choice psychoacoustic task for the evaluation of modulation detection performance and selective auditory attention. (for both arm)","Other: Measurement of the pupil diameter for the evaluation of listening effort during speech perception",{"label":16,"type":17,"description":18,"interventionNames":19},"Healthy volunteers (normal hearing)","ACTIVE_COMPARATOR","Healthy volunteers with a normal tonal audiometry for age",[13,14],[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Forced choice psychoacoustic task for the evaluation of modulation detection performance and selective auditory attention. (for both arm)","Description:\n\n3-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.",[16,9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Measurement of the pupil diameter for the evaluation of listening effort during speech perception","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.",[16,9],[31],"Non",[33],{"name":34,"affiliation":5,"role":35},"Isabelle MOSNIER, MD","PRINCIPAL_INVESTIGATOR",[37,41],{"name":34,"role":38,"phone":39,"phoneExt":25,"email":40},"CONTACT","+33 1 42 16 26 06","isabelle.mosnier@aphp.fr",{"name":42,"role":38,"phone":25,"phoneExt":25,"email":43},"Dorothée ARZOUNIAN, Ph. D","dorothée.arzounian@ens.fr",[45],{"facility":46,"status":47,"city":48,"state":25,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Assistance Publique-Hôpitaux de Paris","RECRUITING","Paris","75013","France","FR",{"type":53,"coordinates":54},"Point",[55,56],2.3488,48.85341,{"lat":56,"lon":55},[59],{"name":34,"role":38,"phone":39,"phoneExt":25,"email":40},{"type":61,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100418840","cochlear-implanted-listening-effort-and-hearing-attention-100418840",false,"NCT04733950","Cochlear Implanted Listening Effort and Hearing Attention","Role of Selective Attention for Sound Modulations in the Listening Effort of Patients With Cochlear Implants","EffICAtt","Inclusion Criteria:\n\nArm 1: patient with Cochlear Implant\n\n* Having a unilateral Oticon Medical cochlear implant\n* Duration of use of the implant of 6 months or more\n* Disyllabic word recognition score of at least 40% on average in silence, to limit \"floor\" effects in hearing tests.\n* Disyllabic word recognition score not exceeding 30% on the contra-lateral ear alone, aided or not, in silence.\n\nArm 2: volunteers with normal hearing\n\n\\- Normal tonal audiometry for the age\n\nFor both\n\n* Age between 18 and 80 years old\n* Mother tongue : French\n* Normal vision with or without correction\n* Absence of eye pathologies (cataracts, nystagmus, amblyopia, macular degeneration).\n* Not taking psychotropic drugs or drugs affecting the parasympathetic nervous system\n* Absence of pathology or neurological history (especially head trauma, stroke).\n* Information and signing of a consent prior to any act related to research\n\nExclusion Criteria:\n\nFor both groups, ensuring the reliability of the pupillometric measurement (Winn et al., 2018):\n\n* Pathologies of the eye: cataracts, nystagmus, amblyopia, macular degeneration.\n* Taking psychotropic drugs and \u002F or drugs affecting the parasympathetic nervous system\n* 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\n\nOthers criteria:\n\n* No affiliation (or being entitled) to a social security scheme\n* Person under State Medical Assistance\n* Person under legal protection (tutorship, curatorship, other…) or under family authorization",true,"ALL","18 Years","80 Years",{"count":75,"type":76},170,"ESTIMATED","INTERVENTIONAL",[79],"NA","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.\n\nThe 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.\n\nSelective 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.\n\nThe 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).\n\nThis 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.",[82],"Sensorineural Hearing Loss",[84,85,86,87,88],"Cochlear implant","Listening effort","Auditory attention","Pupil dilatation","Sound Modulation","2025-01-10",{"date":91,"type":92},"2025-01-13","ACTUAL",{"date":94,"type":92},"2021-12-08",{"date":96,"type":76},"2026-02-22",{"name":5,"class":6},1]