Clinical trial NCT05586555: A Monocentric Study Evaluating Pupillometry as an Objective Measurement for CI Fittings
Official title: A Monocentric Study Evaluating Pupillometry as an Objective Measurement for Cochlear Implant (CI) Fittings
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hearing Loss, Sensorineural
Hearing Loss, Bilateral
Cochlear Hearing Loss
Hearing Loss, Cochlear
Keywords: Cochlear Implant system
Lead sponsor: Oticon Medical
Sponsor class: INDUSTRY
First posted: 2022-10-19
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A control group with normal hearing subjects versus a CI group with cochlear implanted subjects.
Primary purpose: BASIC_SCIENCE

Brief 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.

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:

1. Visit 1 or V1(inclusion) on day 1,
2. Visit 2 or V2 (Experiment 1-+2+3 or Experiment 1+2 or Experiment 3 )\* up to 1 month after V1
3. 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:

1. Visit 1 or Va (inclusion) on day 1,
2. Visit 2 or V2 (experiment) up to 1 month after V1

Eligibility criteria: Inclusion Criteria:

* 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):

  • 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.

Exclusion Criteria:

* 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)
  * 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

Primary outcomes:
measure: Measurement of the pupil dilation response to a range of auditory stimuli (acoustic and electric).
timeFrame: At Visit 2 (Month 1)
Secondary outcomes:
measure: 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.
timeFrame: At Visit 2 (Month 1) and Visit 3 (Month 2)* [* if done]
Other outcomes:
Locations:
city: Paris
country: France
facility: 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
Study officials:
affiliation: Centre de Recherche en Audiologie adulte - CreA- GH Pitié Salpêtrière (APHP)
name: Isabelle Mosnier
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Vaerenberg 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.
citation: Legris 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.
citation: Versfeld 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.
citation: Dingemanse 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.
citation: Bala 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.
citation: Jackson 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.
citation: Kaldy 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.
citation: Russo 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.
citation: Schramm 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.
citation: Sulas 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.
citation: Winn 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.