A Monocentric Study Evaluating Pupillometry as an Objective Measurement for CI Fittings

NCT05586555 | Terminated

• 1 other identifier: OM29
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss, Sensorineural; Hearing Loss, Bilateral; Cochlear Hearing Loss; Hearing Loss, Cochlear

Keywords

Cochlear Implant system

Outcome Measures

Primary Outcomes (1)

• Measurement of the pupil dilation response to a range of auditory stimuli (acoustic and electric).

  Pupil dilation response for each intensity and frequency \[Mean pupil dilatation in milimeters\]

  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.

  At Visit 2 (Month 1) and Visit 3 (Month 2)* [* if done]

Study Arms (2)

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.

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

Other: Pupillometry (Eve-tracking measurements)

Interventions

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.

CI group (cochlear implanted subjects); Control group (normal hearing in regards of age)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oticon Medical: lead

Study Sites (1)

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, France

Location

Related Publications (12)

• 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.

  PMID: 31947524 BACKGROUND

• 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.

  PMID: 24688394 BACKGROUND

• 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.

  PMID: 35326347 BACKGROUND

• 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.

  PMID: 33940918 BACKGROUND

• 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.

  PMID: 34898265 BACKGROUND

• 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.

  PMID: 31792632 BACKGROUND

• 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.

  PMID: 35306326 BACKGROUND

• 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.

  PMID: 33746375 BACKGROUND

• 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.

  PMID: 33240035 BACKGROUND

• 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.

  PMID: 32885711 BACKGROUND

• 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.

  PMID: 35794416 BACKGROUND

• 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.

  PMID: 30261825 BACKGROUND

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Hearing Loss, Bilateral

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Isabelle Mosnier

  Centre de Recherche en Audiologie adulte - CreA- GH Pitié Salpêtrière (APHP)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A control group with normal hearing subjects versus a CI group with cochlear implanted subjects.

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: October 19, 2022
• Study Start: May 2, 2023
• Primary Completion: November 6, 2023
• Study Completion: November 6, 2023
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)