Hearing Loss, SensorineuralPupillOMNCT05586555
A Monocentric Study Evaluating Pupillometry as an Objective Measurement for CI Fittings
A study testing Pupillometry (Eve-tracking measurements) in people with Hearing Loss, Sensorineural and Hearing Loss, Bilateral, run by Oticon Medical at 1 site in France.
Trial summary
This trial is a monocentric, prospective and controlled study of the pupil response to detect hearing threshold and comfortable loudness of normal-hearing (NH) and CI-subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Sensorineural, Hearing Loss, Bilateral, Cochlear Hearing Loss
- What is being tested?
- Pupillometry (Eve-tracking measurements)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2023to 6 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Both groups:
- Adult (≥ 18 years old)
- Fluent in French language
- Affiliation to social security
- Information and signature of a written consent prior to any study-specific procedure
- Control group (normal hearing in regards of age):
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- Normal hearing participants according to pure tone hearing levels defined for age and tested frequency (audiometry ISO 7029 and Wand \& Puel, 2020 recommendations for hearing loss at the tested frequencies)
- CI group (cochlear implant subjects):
- Bilateral, severe-to-profound sensorineural hearing loss, with at least one cochlear implant system
- Using Oticon Medical Neuro Cochlear Implant System (NCIS) or Digisonic Cochlear Implant system (DCIS), unilateral or bilateral
- Duration of cochlear implant experience ≥ 6 months (period from cochlear implant activation to study enrolment)
- Pure Tone Audiometry must be strictly below 50 dBA, CI aided.
Who cannot join
- Both groups, according to the best practices for pupillometry (Winn et al., 2018):
- Eye diseases: nystagmus, amblyopia, and macular degeneration
- Severe head injury or any history of significant neurological problems: These issues can affect gaze stability, congruence of eye movements, and pupil dilation
- Concomitant medication that can impact the parasympathetic autonomic nervous system
- Person under State Medical Assistance (AME for "Aide medical d'état" in French)
- Use of one of the following treatments: Trihexyphenidyl, Biperiden or Tropatepine (anticholinergics, commonly used in the treatment of Parkinson's disease)
Show all 9Show fewer
- Person under legal protection (guardianship, curators, other, etc.) or under family authorization
- Unwillingness or inability to comply with all investigational requirements
- Additional cognitive, medical, or social handicaps that would prevent completion of all study requirements
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Recherche en Audiologie adulte GH Pitié-Salpêtrière, APHP Sorbonne Université, Unité Fonctionnelle Implants auditifs et Explorations Fonctionnelles, 52 Bd Vincent Auriol, 75013 Paris, France
Paris, 75013
About this study
Official title: A Monocentric Study Evaluating Pupillometry as an Objective Measurement for Cochlear Implant (CI) Fittings
This trial is a monocentric, prospective and controlled study of the pupil response to detect hearing threshold and comfortable loudness of normal-hearing (NH) and CI-subjects.
Read the detailed description
The purpose of the clinical investigation is to explore the pupil dilation response of subjects with a cochlear implant and to provide proof of concept that it is possible to perform the adaptation of a cochlear implant using pupillometry.
The population of this study is divided in 2 group:
- A control group with normal-hearing listeners.
- An Cl group with subjects with bilateral, severe-to-profound sensorineural hearing loss, with at least one cochlear implant for more than 6 months.
Mainly used in audiology to evaluate listening effort, pupillometry is an objective measure that could also be used for fittings. Studies have shown that sound intensity influence pupil dilation. indeed, normal hearing and hearing aids subjects exhibit larger pupil responses with increasing intensity/loudness. The purpose of this study is to explore the pupil dilation response of cochlear implant subjects and to provide a proof of concept that we can perform cochlear implant fitting using pupillometry.
Implanted subjects (Cl group) will undergo up to 3 visits:
- Visit 1 or V1(inclusion) on day 1,
- Visit 2 or V2 (Experiment 1-+2+3 or Experiment 1+2 or Experiment 3 )* up to 1 month after V1
- Visit 3 or V3 (Experiment 1+2 or Experiment 3, optional)* up to 1 month after V2 *lt is up to investigator decision to conduct experiment 1+2 and experiment 3 the same day or in on independent visit (no matter in which order)
Normal-hearing listeners (control group) will undergo up to 2 visits:
- Visit 1 or Va (inclusion) on day 1,
- Visit 2 or V2 (experiment) up to 1 month after V1
- Conditions
- Hearing Loss, Sensorineural, Hearing Loss, Bilateral, Cochlear Hearing Loss, Hearing Loss, Cochlear
- Being tested
- Pupillometry (Eve-tracking measurements)
- Keywords
- Cochlear Implant system
- Medical subject headings
- Hearing Loss, Sensorineural, Hearing Loss, Bilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pupillometry (Eve-tracking measurements)Other
Pupillometry measurements are carried out by a dedicated device (eye tracker), which includes cameras allowing the measurement of pupillary dilation. The subject stands in front of a screen and fixes a point in the center of the screen, the cameras placed on the screen allowing a measurement of the pupillary dilation in a non-invasive way. These eye-tracking measurements are performed simultaneously with an auditory task and allow to study the pupil's response to different stimuli.
| Study group | Role | What they receive |
|---|---|---|
| Control group (normal hearing in regards of age) | Other | Normal hearing participants according to pure tone hearing levels defined for age and tested frequency (audiometry ISO 7029 and Wang \& Puel, 2020 recommendations for hearing loss at the tested frequencies). Total of 32 subjects in this arm. Receives: Other: Pupillometry (Eve-tracking measurements) |
| CI group (cochlear implanted subjects) | Experimental | Cochlear implanted subjects with bilateral, severe-to-profound sensorineural hearing loss, with at least one Oticon Medical cochlear implant system .
Up to 40 subjects in this arm:
* 20 subjects will perform experiment 1 \& 2
* 20 subjects will perform experiment 3
* The subjects of the experiment 3 ore either those taken part to experiment 1 and 2, or subjects who only take port to the experiment 3 Receives: Other: Pupillometry (Eve-tracking measurements) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the pupil dilation response to a range of auditory stimuli (acoustic and electric).
Pupil dilation response for each intensity and frequency [Mean pupil dilatation in milimeters]
Measured: At Visit 2 (Month 1)
Secondary outcomes (1)
Evaluation of the loudness perception of the subjects regarding the different auditory stimuli (acoustic and electric) to correlate the results to the pupil dilation response.
Loudness score corresponding to each pupil dilation response. [Using Oticon Medical Loudness scale: scale from 0 to 10 following the ISO 16832. 0 (zero) corresponding to inaudible level and 10 to extremely loud (intolerable) sounds.]
Measured: At Visit 2 (Month 1) and Visit 3 (Month 2)* [* if done]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start2 May 2023
- Primary completion6 Nov 2023
- Study completion6 Nov 2023
Why it stopped: Demant's transfer of its cochlear implant activity to Cochlear. Slow recruitment and misalignment with Cochlear's interests are also determining factors.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A control group with normal hearing subjects versus a CI group with cochlear implanted subjects.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oticon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Isabelle Mosnier, Principal investigator, Centre de Recherche en Audiologie adulte - CreA- GH Pitié Salpêtrière (APHP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586555
- Sponsor's protocol ID
- OM29
- Acronym
- PupillOM
- Status last verified
- Mar 2024
- First submitted
- 20 Sep 2022
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang J, Puel JL. Presbycusis: An Update on Cochlear Mechanisms and Therapies. J Clin Med. 2020 Jan 14;9(1):218. doi: 10.3390/jcm9010218.
PubMed 31947524Vaerenberg B, Smits C, De Ceulaer G, Zir E, Harman S, Jaspers N, Tam Y, Dillon M, Wesarg T, Martin-Bonniot D, Gartner L, Cozma S, Kosaner J, Prentiss S, Sasidharan P, Briaire JJ, Bradley J, Debruyne J, Hollow R, Patadia R, Mens L, Veekmans K, Greisiger R, Harboun-Cohen E, Borel S, Tavora-Vieira D, Mancini P, Cullington H, Ng AH, Walkowiak A, Shapiro WH, Govaerts PJ. Cochlear implant programming: a global survey on the state of the art. ScientificWorldJournal. 2014 Feb 4;2014:501738. doi: 10.1155/2014/501738. eCollection 2014.
PubMed 24688394Legris E, Galvin J, Mofid Y, Aguillon-Hernandez N, Roux S, Aoustin JM, Gomot M, Bakhos D. Relationship between Behavioral and Objective Measures of Sound Intensity in Normal-Hearing Listeners and Hearing-Aid Users: A Pilot Study. Brain Sci. 2022 Mar 15;12(3):392. doi: 10.3390/brainsci12030392.
PubMed 35326347Versfeld NJ, Lie S, Kramer SE, Zekveld AA. Informational masking with speech-on-speech intelligibility: Pupil response and time-course of learning. J Acoust Soc Am. 2021 Apr;149(4):2353. doi: 10.1121/10.0003952.
PubMed 33940918Dingemanse G, Goedegebure A. Listening Effort in Cochlear Implant Users: The Effect of Speech Intelligibility, Noise Reduction Processing, and Working Memory Capacity on the Pupil Dilation Response. J Speech Lang Hear Res. 2022 Jan 12;65(1):392-404. doi: 10.1044/2021_JSLHR-21-00230. Epub 2021 Dec 13.
PubMed 34898265Bala ADS, Whitchurch EA, Takahashi TT. Human Auditory Detection and Discrimination Measured with the Pupil Dilation Response. J Assoc Res Otolaryngol. 2020 Feb;21(1):43-59. doi: 10.1007/s10162-019-00739-x. Epub 2019 Dec 2.
PubMed 31792632Jackson IR, Sirois S. But that's possible! Infants, pupils, and impossible events. Infant Behav Dev. 2022 May;67:101710. doi: 10.1016/j.infbeh.2022.101710. Epub 2022 Mar 17.
PubMed 35306326Kaldy Z, Blaser E. Putting effort into infant cognition. Curr Dir Psychol Sci. 2020 Apr;29(2):180-185. doi: 10.1177/0963721420903015. Epub 2020 Feb 27.
PubMed 33746375Russo FY, Hoen M, Karoui C, Demarcy T, Ardoint M, Tuset MP, De Seta D, Sterkers O, Lahlou G, Mosnier I. Pupillometry Assessment of Speech Recognition and Listening Experience in Adult Cochlear Implant Patients. Front Neurosci. 2020 Nov 6;14:556675. doi: 10.3389/fnins.2020.556675. eCollection 2020.
PubMed 33240035Schramm D, Chen J, Morris DP, Shoman N, Philippon D, Caye-Thomasen P, Hoen M, Karoui C, Laplante-Levesque A, Gnansia D. Clinical efficiency and safety of the oticon medical neuro cochlear implant system: a multicenter prospective longitudinal study. Expert Rev Med Devices. 2020 Sep;17(9):959-967. doi: 10.1080/17434440.2020.1814741. Epub 2020 Oct 3.
PubMed 32885711Sulas E, Hasan PY, Zhang Y, Patou F. Streamlining experiment design in cognitive hearing science using OpenSesame. Behav Res Methods. 2023 Jun;55(4):1965-1979. doi: 10.3758/s13428-022-01886-5. Epub 2022 Jul 6.
PubMed 35794416Winn MB, Wendt D, Koelewijn T, Kuchinsky SE. Best Practices and Advice for Using Pupillometry to Measure Listening Effort: An Introduction for Those Who Want to Get Started. Trends Hear. 2018 Jan-Dec;22:2331216518800869. doi: 10.1177/2331216518800869.
PubMed 30261825
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Monocentric Study Evaluating Pupillometry as an Objective Measurement for Cochlear Implant (CI) Fittings
- ClinicalTrials.gov ID
- NCT05586555
- Acronym / sponsor ID
- PupillOM / OM29
- Conditions
- Hearing Loss, Sensorineural, Hearing Loss, Bilateral, Cochlear Hearing Loss, Hearing Loss, Cochlear
- Keywords
- Cochlear Implant system
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Demant's transfer of its cochlear implant activity to Cochlear. Slow recruitment and misalignment with Cochlear's interests are also determining factors.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Oticon MedicalIndustry (pharma, biotech, devices)
- Study start
- 2 May 2023 (actual)
- Primary completion
- 6 Nov 2023 (actual)
- Study completion
- 6 Nov 2023 (actual)
- First posted
- 19 Oct 2022 (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.
This trial is a monocentric, prospective and controlled study of the pupil response to detect hearing threshold and comfortable loudness of normal-hearing (NH) and CI-subjects.
Detailed description
The purpose of the clinical investigation is to explore the pupil dilation response of subjects with a cochlear implant and to provide proof of concept that it is possible to perform the adaptation of a cochlear implant using pupillometry.
The population of this study is divided in 2 group:
- A control group with normal-hearing listeners.
- An Cl group with subjects with bilateral, severe-to-profound sensorineural hearing loss, with at least one cochlear implant for more than 6 months.
Mainly used in audiology to evaluate listening effort, pupillometry is an objective measure that could also be used for fittings. Studies have shown that sound intensity influence pupil dilation. indeed, normal hearing and hearing aids subjects exhibit larger pupil responses with increasing intensity/loudness. The purpose of this study is to explore the pupil dilation response of cochlear implant subjects and to provide a proof of concept that we can perform cochlear implant fitting using pupillometry.
Implanted subjects (Cl group) will undergo up to 3 visits:
- Visit 1 or V1(inclusion) on day 1,
- Visit 2 or V2 (Experiment 1-+2+3 or Experiment 1+2 or Experiment 3 )* up to 1 month after V1
- Visit 3 or V3 (Experiment 1+2 or Experiment 3, optional)* up to 1 month after V2 *lt is up to investigator decision to conduct experiment 1+2 and experiment 3 the same day or in on independent visit (no matter in which order)
Normal-hearing listeners (control group) will undergo up to 2 visits:
- Visit 1 or Va (inclusion) on day 1,
- Visit 2 or V2 (experiment) up to 1 month after V1
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A control group with normal hearing subjects versus a CI group with cochlear implanted subjects.
| Arm | Type | Receives |
|---|---|---|
| Control group (normal hearing in regards of age) | Other | Other: Pupillometry (Eve-tracking measurements)Normal hearing participants according to pure tone hearing levels defined for age and tested frequency (audiometry ISO 7029 and Wang \& Puel, 2020 recommendations for hearing loss at the tested frequencies). Total of 32 subjects in this arm. |
| CI group (cochlear implanted subjects) | Experimental | Other: Pupillometry (Eve-tracking measurements)Cochlear implanted subjects with bilateral, severe-to-profound sensorineural hearing loss, with at least one Oticon Medical cochlear implant system . Up to 40 subjects in this arm: * 20 subjects will perform experiment 1 \& 2 * 20 subjects will perform experiment 3 * The subjects of the experiment 3 ore either those taken part to experiment 1 and 2, or subjects who only take port to the experiment 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Both groups:
- Control group (normal hearing in regards of age):
- CI group (cochlear implant subjects):
Key exclusion criteria (9 listed)
- Both groups, according to the best practices for pupillometry (Winn et al., 2018):
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 |
|---|---|---|
| Pupillometry (Eve-tracking measurements)Pupillometry measurements are carried out by a dedicated device (eye tracker), which includes cameras allowing the measurement of pupillary dilation. The subject stands in front of a screen and fixes a point in the center of the screen, the cameras placed on the screen allowing a measurement of the pupillary dilation in a non-invasive way. These eye-tracking measurements are performed simultaneously with an auditory task and allow to study the pupil's response to different stimuli. | Other | CI group (cochlear implanted subjects), Control group (normal hearing in regards of age) |
Primary outcome
Measurement of the pupil dilation response to a range of auditory stimuli (acoustic and electric).
Time frame: At Visit 2 (Month 1)
Pupil dilation response for each intensity and frequency [Mean pupil dilatation in milimeters]
1 secondary outcome
Evaluation of the loudness perception of the subjects regarding the different auditory stimuli (acoustic and electric) to correlate the results to the pupil dilation response.
Time frame: At Visit 2 (Month 1) and Visit 3 (Month 2)* [* if done]
Results and safety
The study was stopped early (reason given: Demant's transfer of its cochlear implant activity to Cochlear. Slow recruitment and misalignment with Cochlear's interests are also determining factors.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Background: PubMed 31947524Wang J, Puel JL. Presbycusis: An Update on Cochlear Mechanisms and Therapies. J Clin Med. 2020 Jan 14;9(1):218. doi: 10.3390/jcm9010218.
- Background: PubMed 24688394Vaerenberg B, Smits C, De Ceulaer G, Zir E, Harman S, Jaspers N, Tam Y, Dillon M, Wesarg T, Martin-Bonniot D, Gartner L, Cozma S, Kosaner J, Prentiss S, Sasidharan P, Briaire JJ, Bradley J, Debruyne J, Hollow R, Patadia R, Mens L, Veekmans K, Greisiger R, Harboun-Cohen E, Borel S, Tavora-Vieira D, Mancini P, Cullington H, Ng AH, Walkowiak A, Shapiro WH, Govaerts PJ. Cochlear implant programming: a global survey on the state of the art. ScientificWorldJournal. 2014 Feb 4;2014:501738. doi: 10.1155/2014/501738. eCollection 2014.
- Background: PubMed 35326347Legris E, Galvin J, Mofid Y, Aguillon-Hernandez N, Roux S, Aoustin JM, Gomot M, Bakhos D. Relationship between Behavioral and Objective Measures of Sound Intensity in Normal-Hearing Listeners and Hearing-Aid Users: A Pilot Study. Brain Sci. 2022 Mar 15;12(3):392. doi: 10.3390/brainsci12030392.
- Background: PubMed 33940918Versfeld NJ, Lie S, Kramer SE, Zekveld AA. Informational masking with speech-on-speech intelligibility: Pupil response and time-course of learning. J Acoust Soc Am. 2021 Apr;149(4):2353. doi: 10.1121/10.0003952.
- Background: PubMed 34898265Dingemanse G, Goedegebure A. Listening Effort in Cochlear Implant Users: The Effect of Speech Intelligibility, Noise Reduction Processing, and Working Memory Capacity on the Pupil Dilation Response. J Speech Lang Hear Res. 2022 Jan 12;65(1):392-404. doi: 10.1044/2021_JSLHR-21-00230. Epub 2021 Dec 13.
- Background: PubMed 31792632Bala ADS, Whitchurch EA, Takahashi TT. Human Auditory Detection and Discrimination Measured with the Pupil Dilation Response. J Assoc Res Otolaryngol. 2020 Feb;21(1):43-59. doi: 10.1007/s10162-019-00739-x. Epub 2019 Dec 2.
- Background: PubMed 35306326Jackson IR, Sirois S. But that's possible! Infants, pupils, and impossible events. Infant Behav Dev. 2022 May;67:101710. doi: 10.1016/j.infbeh.2022.101710. Epub 2022 Mar 17.
- Background: PubMed 33746375Kaldy Z, Blaser E. Putting effort into infant cognition. Curr Dir Psychol Sci. 2020 Apr;29(2):180-185. doi: 10.1177/0963721420903015. Epub 2020 Feb 27.
- Background: PubMed 33240035Russo FY, Hoen M, Karoui C, Demarcy T, Ardoint M, Tuset MP, De Seta D, Sterkers O, Lahlou G, Mosnier I. Pupillometry Assessment of Speech Recognition and Listening Experience in Adult Cochlear Implant Patients. Front Neurosci. 2020 Nov 6;14:556675. doi: 10.3389/fnins.2020.556675. eCollection 2020.
- Background: PubMed 32885711Schramm D, Chen J, Morris DP, Shoman N, Philippon D, Caye-Thomasen P, Hoen M, Karoui C, Laplante-Levesque A, Gnansia D. Clinical efficiency and safety of the oticon medical neuro cochlear implant system: a multicenter prospective longitudinal study. Expert Rev Med Devices. 2020 Sep;17(9):959-967. doi: 10.1080/17434440.2020.1814741. Epub 2020 Oct 3.
- Background: PubMed 35794416Sulas E, Hasan PY, Zhang Y, Patou F. Streamlining experiment design in cognitive hearing science using OpenSesame. Behav Res Methods. 2023 Jun;55(4):1965-1979. doi: 10.3758/s13428-022-01886-5. Epub 2022 Jul 6.
- Background: PubMed 30261825Winn MB, Wendt D, Koelewijn T, Kuchinsky SE. Best Practices and Advice for Using Pupillometry to Measure Listening Effort: An Introduction for Those Who Want to Get Started. Trends Hear. 2018 Jan-Dec;22:2331216518800869. doi: 10.1177/2331216518800869.
- 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. This study is not recruiting at the moment.
Isabelle Mosnier principal investigator
Centre de Recherche en Audiologie adulte - CreA- GH Pitié Salpêtrière (APHP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pupillometry (Eve-tracking measurements) in people with Hearing Loss, Sensorineural and Hearing Loss, Bilateral, run by Oticon Medical 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 12 inclusion and 9 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: stopped early, as of the sponsor's last update on 29 Mar 2024. 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?
The study was stopped early (reason given: Demant's transfer of its cochlear implant activity to Cochlear. Slow recruitment and misalignment with Cochlear's interests are also determining factors.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the pupil dilation response to a range of auditory stimuli (acoustic and electric). (time frame: At Visit 2 (Month 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05586555, which also lists 12 linked publications.
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 29 Mar 2024.