Back to resultsA Monocentric Study Evaluating Pupillometry as an Objective Measurement for CI Fittings (PupillOM)
Primary Purpose
Hearing Loss, Sensorineural, Hearing Loss, Bilateral, Cochlear Hearing Loss
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pupillometry (Eve-tracking measurements)
Sponsored by
About this trial
This is an interventional basic science trial for Hearing Loss, Sensorineural focused on measuring Cochlear Implant system
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
Sites / Locations
- 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, FranceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Control group (normal hearing in regards of age)
CI group (cochlear implanted subjects)
Arm Description
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.
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
Outcomes
Primary Outcome Measures
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]
Secondary Outcome Measures
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.]
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05586555
Brief Title
A Monocentric Study Evaluating Pupillometry as an Objective Measurement for CI Fittings
Acronym
PupillOM
Official Title
A Monocentric Study Evaluating Pupillometry as an Objective Measurement for Cochlear Implant (CI) Fittings
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2023 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oticon Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sensorineural, Hearing Loss, Bilateral, Cochlear Hearing Loss, Hearing Loss, Cochlear
Keywords
Cochlear Implant system
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A control group with normal hearing subjects versus a CI group with cochlear implanted subjects.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group (normal hearing in regards of age)
Arm Type
Other
Arm Description
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.
Arm Title
CI group (cochlear implanted subjects)
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Pupillometry (Eve-tracking measurements)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measurement of the pupil dilation response to a range of auditory stimuli (acoustic and electric).
Description
Pupil dilation response for each intensity and frequency [Mean pupil dilatation in milimeters]
Time Frame
At Visit 2 (Month 1)
Secondary Outcome Measure Information:
Title
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.
Description
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.]
Time Frame
At Visit 2 (Month 1) and Visit 3 (Month 2)* [* if done]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laure Gleonec
Phone
+33(0)493951818
Email
laln@oticonmedical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Chouikh
Phone
+33(0)493951818
Email
saoh@oticonmedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle Mosnier
Organizational Affiliation
Centre de Recherche en Audiologie adulte - CreA- GH Pitié Salpêtrière (APHP)
Official's Role
Principal Investigator
Facility Information:
Facility Name
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
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Mosnier, PH
Phone
+331 42 16 26 06
Email
isabelle.mosnier@aphp.fr
First Name & Middle Initial & Last Name & Degree
Nassima Schmoll
Phone
+331 42 16 30 89
Email
nassima.schmoll@aphp.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31947524
Citation
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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.
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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.
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PubMed Identifier
33940918
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.
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PubMed Identifier
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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.
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A Monocentric Study Evaluating Pupillometry as an Objective Measurement for CI Fittings
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