Hearing Loss, Sensorineural Clinical Trial
— PupillOMOfficial title:
A Monocentric Study Evaluating Pupillometry as an Objective Measurement for Cochlear Implant (CI) Fittings
NCT number | NCT05586555 |
Other study ID # | OM29 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2, 2023 |
Est. completion date | November 6, 2023 |
Verified date | March 2024 |
Source | Oticon Medical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 13 |
Est. completion date | November 6, 2023 |
Est. primary completion date | November 6, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | 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 |
Lead Sponsor | Collaborator |
---|---|
Oticon Medical |
France,
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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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.] | At Visit 2 (Month 1) and Visit 3 (Month 2)* [* if done] |
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