Sensorineural Hearing LossEffICAttNCT04733950
Cochlear Implanted Listening Effort and Hearing Attention
A study testing Forced choice psychoacoustic task for the evaluation of modulation detection performance and selective auditory attention. (for both arm) and Measurement of the pupil diameter for the evaluation of listening effort during speech perception in people with Sensorineural Hearing Loss, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sensorineural Hearing Loss
- What is being tested?
- Forced choice psychoacoustic task for the evaluation of modulation detection performance and selective auditory attention. (for both arm) and Measurement of the pupil diameter for the evaluation of listening effort during speech perception
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteFrance
- Study dates
- 8 Dec 2021to 22 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dorothée ARZOUNIAN, Ph. D contact
France1 site, 1 recruiting
- Recruiting
Assistance Publique-Hôpitaux de Paris
Paris, 75013
Isabelle MOSNIER, MD, +33 1 42 16 26 06, isabelle.mosnier@aphp.fr
About this study
Official title: Role of Selective Attention for Sound Modulations in the Listening Effort of Patients With Cochlear Implants
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.
Read more
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.
Read the detailed description
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.
The test will comprise two conditions presented alternately. In the first condition, there will be no other modulation than the target. In the second condition, a distracting modulation will be applied to the non-target carrier, in the three intervals. Both target and distracting modulations will have the same 8-Hz rate. Performance in these two conditions will be assessed the measurement of amplitude modulation detection thresholds (AMDT) using an adaptive procedure, repeated twice per condition. The difference in performance between the two conditions will serve as an index of the auditory attentional capacity of the subject.
Participants will perform a training followed by the AMDT measurements, as well as tests with constant modulation levels and joint pupil diameter measurement, all of which will be distributed in blocks meant to last between 5 and 8 minutes and interleaved by breaks for a total of about 40 minutes.
The final, speech recognition tests will consist in a consonant identification task. The settings of the processor in these tests will be identical to the patient's processor usual settings, and sounds will be presented in free field through loudspeakers, at a comfortable level (65 decibel Sound Pressure Level for target speech and 55 decibel Sound Pressure Level for interfering speech). In each trial, participants will be presented with the recording of a pseudoword, pronounced by a female voice, of the form [aCaCa] where [C] is a consonant to identify among 16 alternatives. This test will be performed once in silence and a second time in the presence of interfering pseudospeech pronounced by a different voice, with a signal-to-noise ratio of +10 decibel. There will be 48 trials in each condition. Pupil diameter will be recorded during the test so as to measure listening effort in each condition as the mean pupil dilation response with reference to a pre-stimulus baseline. The difference of this pupil dilation response between the two conditions will serve as a measurement of the amount of listening effort induced by the presence of interfering speech.
During data analysis, the linear correlation between the auditory attention capacity index (from the psychoacoustic test) and the interference-induced listening effort measurement (from the speech recognition test) will be tested by means of a Pearson test, separately for each of the two subject groups (cochlear implant patients and normal-hearing healthy volunteers), with a 0.05 p-value significance threshold.
- Conditions
- Sensorineural Hearing Loss
- Being tested
- Forced choice psychoacoustic task for the evaluation of modulation detection performance and selective auditory attention. (for both arm), Measurement of the pupil diameter for the evaluation of listening effort during speech perception
- Keywords
- Cochlear implant, Listening effort, Auditory attention, Pupil dilatation, Sound Modulation
- Medical subject headings
- Hearing Loss, Sensorineural, Mydriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forced choice psychoacoustic task for the evaluation of modulation detection performance and selective auditory attention. (for both arm)Other
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.
Measurement of the pupil diameter for the evaluation of listening effort during speech perceptionOther
Also called Non
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with cochlear implant | Experimental | Patients with cochlear implant for 6 months and more Receives: 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 |
| Healthy volunteers (normal hearing) | Active comparator | Healthy volunteers with a normal tonal audiometry for age Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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).
Measured: Day one
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.
Measured: Day one
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.
Measured: Day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start8 Dec 2021
- Primary completion22 Feb 2026 (estimated)
- Study completion22 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensorineural Hearing LossStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle MOSNIER, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733950
- Sponsor's protocol ID
- APHP201188
- Acronym
- EffICAtt
- Status last verified
- Jan 2025
- First submitted
- 24 Jan 2021
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Selective Attention for Sound Modulations in the Listening Effort of Patients With Cochlear Implants
- ClinicalTrials.gov ID
- NCT04733950
- Acronym / sponsor ID
- EffICAtt / APHP201188
- Conditions
- Sensorineural Hearing Loss
- Keywords
- Cochlear implant, Listening effort, Auditory attention, Pupil dilatation, Sound Modulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 8 Dec 2021 (actual)
- Primary completion
- 22 Feb 2026 (estimated)
- Study completion
- 22 Feb 2026 (estimated)
- First posted
- 2 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The test will comprise two conditions presented alternately. In the first condition, there will be no other modulation than the target. In the second condition, a distracting modulation will be applied to the non-target carrier, in the three intervals. Both target and distracting modulations will have the same 8-Hz rate. Performance in these two conditions will be assessed the measurement of amplitude modulation detection thresholds (AMDT) using an adaptive procedure, repeated twice per condition. The difference in performance between the two conditions will serve as an index of the auditory attentional capacity of the subject.
Participants will perform a training followed by the AMDT measurements, as well as tests with constant modulation levels and joint pupil diameter measurement, all of which will be distributed in blocks meant to last between 5 and 8 minutes and interleaved by breaks for a total of about 40 minutes.
The final, speech recognition tests will consist in a consonant identification task. The settings of the processor in these tests will be identical to the patient's processor usual settings, and sounds will be presented in free field through loudspeakers, at a comfortable level (65 decibel Sound Pressure Level for target speech and 55 decibel Sound Pressure Level for interfering speech). In each trial, participants will be presented with the recording of a pseudoword, pronounced by a female voice, of the form [aCaCa] where [C] is a consonant to identify among 16 alternatives. This test will be performed once in silence and a second time in the presence of interfering pseudospeech pronounced by a different voice, with a signal-to-noise ratio of +10 decibel. There will be 48 trials in each condition. Pupil diameter will be recorded during the test so as to measure listening effort in each condition as the mean pupil dilation response with reference to a pre-stimulus baseline. The difference of this pupil dilation response between the two conditions will serve as a measurement of the amount of listening effort induced by the presence of interfering speech.
During data analysis, the linear correlation between the auditory attention capacity index (from the psychoacoustic test) and the interference-induced listening effort measurement (from the speech recognition test) will be tested by means of a Pearson test, separately for each of the two subject groups (cochlear implant patients and normal-hearing healthy volunteers), with a 0.05 p-value significance threshold.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with cochlear implant | Experimental | 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 perceptionPatients with cochlear implant for 6 months and more |
| Healthy volunteers (normal hearing) | Active comparator | 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 perceptionHealthy volunteers with a normal tonal audiometry for age |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
- No affiliation (or being entitled) to a social security scheme
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Forced choice psychoacoustic task for the evaluation of modulation detection performance and selective auditory attention. (for both arm)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. | Other | Healthy volunteers (normal hearing), Patients with cochlear implant |
| Measurement of the pupil diameter for the evaluation of listening effort during speech perceptionAlso: NonPupil 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. | Other | Healthy volunteers (normal hearing), Patients with cochlear implant |
Primary outcome
Contribution of selective auditory attention recruitment to listening effort during speech perception in interfering noise
Time frame: 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
3 secondary outcomes
The listening effort during speech identification in the presence of another interfering speech
Time frame: Day one
The link between difficulty, performance and effort during modulation detection
Time frame: Day one
Comparison between the two arms (patients with cochlear implant and volunteers with normal hearing) of the assessments of performances and listening effort.
Time frame: Day one
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dorothée ARZOUNIAN, Ph. D contact
Isabelle MOSNIER, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forced choice psychoacoustic task for the evaluation of modulation detection performance and selective auditory attention. (for both arm) and Measurement of the pupil diameter for the evaluation of listening effort during speech perception in people with Sensorineural Hearing Loss, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabelle MOSNIER, MD (+33 1 42 16 26 06, isabelle.mosnier@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contribution of selective auditory attention recruitment to listening effort during speech perception in interfering noise (time frame: at study inclusions completion, 18 months after firsth enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.