Role of Selective Attention for Sound Modulations in the Listening Effort of Patients With Cochlear Implants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Contribution of selective auditory attention recruitment to listening effort during speech perception in interfering noise
研究概览
简要总结
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.
详细描述
Participants to this trial will be adult patients with cochlear implants (experimental group) and adults with normal-for-the-age hearing (healthy volunteers or controls), recruited in a single center (Reference Centre for Cochlear Implants in Adults, Otorhinolaryngology Service, Auditory Implants Functional Unit, Pitié-Salpêtrière Hospital Group). All patients followed-up at the clinical center and satisfying the inclusion criteria will be addressed a mail informing them about the study. They will be contacted by phone after a reflexion delay of 15 days to check their understanding of the study and probe their agreement or refusal to participate. Healthy controls will be recruited by a call broadcasted through mailing lists dedicated to volunteers for scientific experiments. Those who answer the call by phone or email will be convoked by order of contact, according to the study's needs, and given information about the study. Signed informed consent will be collected from all participants prior to participation, on the day of inclusion, as well as their demographic data, educational level and, for patients with cochlear implants, the date of implantation and hearing loss etiology. Each subject will be identified by a unique series of 9 alphanumerical characters. Healthy volunteers will undergo tonal audiometry and will be definitively included in the study only after normal hearing for the age is confirmed.
The entire participation is planned to take place in a single session lasting 1 hour and 40 minutes, on the day of inclusion, including consent collection, preliminary measurements (CT thresholds for patients, audiometry for controls), material calibration, psychoacoustic tests and speech recognition tests with oculometry. Only as an exception in cases where the entire session could not be completed in the allocated time, participants will be invited to come back for a second session on a different day to finish incomplete tests.
All tests will be performed in a soundproofed booth. Participants will sit in front of a screen displaying a visual fixation point during trials, as well as relevant information (end of trial, response alternatives, performance feedback). Pupil diameter will be recorded during the tests using an eye-tracker device (Tobii TX300). Prior to the tests, ambient luminosity will be adjusted so that the subject's pupil be at the center of its measured dynamics. Cochlear implant patients will be equipped with an implant processor dedicated to the experiment (reference processor), ensuring their own processor's settings won't be modified and that the tests be performed with a well-functioning processor.
The psychoacoustic tests will consist in an amplitude modulation detection task with a 3-interval, 3-alternative forced choice design. In each trial, participants will be presented with 3 successive sounds in a random order, only one of which constrains the target amplitude modulation and which the participant must report. All presented sounds will contain two superimposed sinusoidal carriers (e.g. 500 Hz and 4000 Hz). The target amplitude modulation will be applied to only one these two carriers (the target carrier), in only one of the three presented sound.
The settings of the reference processor during these tests will deactivate all electrodes instead of two, making sure that the stimulation is maximally focused in two, well separated regions of the cochlea. The acoustic frequency of these active electrodes might be modified compared to the usual processor, so as to guarantee that they will each be maximally activated by one of the two stimulus carriers. The dynamics of the active electrodes will be set with the own C and T thresholds of the patient, and sound calibration will ensure that the average stimulation level correspond to 50% of the CT dynamics. Stimuli will be presented to patients through the analogic input of the reference processor and through headphones, on a single, randomly-drawn side (left or right), at an average level of 70 decibel Sound Pressure Level, to the healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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
排除标准
- •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
结局指标
主要结局
Contribution of selective auditory attention recruitment to listening effort during speech perception in interfering noise
时间窗: at study inclusions completion, 18 months after firsth enrollment
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
次要结局
- The link between difficulty, performance and effort during modulation detection(Day one)
- The listening effort during speech identification in the presence of another interfering speech(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)