Clinical trial NCT03870217: Comparing Site-selection Strategies
Official title: Comparing Site-selection Strategies for Improving Speech Recognition Outcomes
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Deafness
Lead sponsor: East Carolina University
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 0
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children and adults with cochlear implants

Brief summary: Several studies in the past have tried to deactivate electrodes that are less optimal to improve speech recognition outcomes. The study aims to compare the measures based on which the deactivation was performed. The investigators aim to first examine if the measures are strongly correlated each other, and then compare the deactivation effects across measures. These measures are mainly behavioral including electrode discrimination, amplitude modulation detection thresholds, low-rate and focused detection thresholds and electrode-modiolus distance. The endpoint of the study is speech recognition performance post deactivation.


Eligibility criteria: Inclusion Criteria:

* Native speakers of English
* Cochlear Nucleus cochlear implant users or Advanced Bionics users
* Postlingually deafened
* Has had device experience for at least one year
* Can be child or adult at the time of enrollment

Exclusion Criteria:

* None

Primary outcomes:
measure: Speech recognition with deactivation
timeFrame: 12 months post award notice and will take up to 3.5 years to complete
Secondary outcomes:
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Department of Communication Sciences and Disorders, ECU
state: North Carolina
Study officials:
affiliation: East Carolina University
name: Ning Zhou, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Debruyne JA, Francart T, Janssen AM, Douma K, Brokx JP. Fitting prelingually deafened adult cochlear implant users based on electrode discrimination performance. Int J Audiol. 2017 Mar;56(3):174-185. doi: 10.1080/14992027.2016.1243262. Epub 2016 Oct 19.
citation: Garadat SN, Zwolan TA, Pfingst BE. Using temporal modulation sensitivity to select stimulation sites for processor MAPs in cochlear implant listeners. Audiol Neurootol. 2013;18(4):247-60. doi: 10.1159/000351302. Epub 2013 Jul 20.
citation: Nadol JB Jr. Patterns of neural degeneration in the human cochlea and auditory nerve: implications for cochlear implantation. Otolaryngol Head Neck Surg. 1997 Sep;117(3 Pt 1):220-8. doi: 10.1016/s0194-5998(97)70178-5.
citation: Nadol JB Jr, Young YS, Glynn RJ. Survival of spiral ganglion cells in profound sensorineural hearing loss: implications for cochlear implantation. Ann Otol Rhinol Laryngol. 1989 Jun;98(6):411-6. doi: 10.1177/000348948909800602.
citation: Noble JH, Labadie RF, Gifford RH, Dawant BM. Image-guidance enables new methods for customizing cochlear implant stimulation strategies. IEEE Trans Neural Syst Rehabil Eng. 2013 Sep;21(5):820-9. doi: 10.1109/TNSRE.2013.2253333. Epub 2013 Mar 19.
citation: Seyyedi M, Viana LM, Nadol JB Jr. Within-subject comparison of word recognition and spiral ganglion cell count in bilateral cochlear implant recipients. Otol Neurotol. 2014 Sep;35(8):1446-50. doi: 10.1097/MAO.0000000000000443.
citation: Zhou N. Monopolar Detection Thresholds Predict Spatial Selectivity of Neural Excitation in Cochlear Implants: Implications for Speech Recognition. PLoS One. 2016 Oct 31;11(10):e0165476. doi: 10.1371/journal.pone.0165476. eCollection 2016.
citation: Zhou N. Deactivating stimulation sites based on low-rate thresholds improves spectral ripple and speech reception thresholds in cochlear implant users. J Acoust Soc Am. 2017 Mar;141(3):EL243. doi: 10.1121/1.4977235.
citation: Zhou N, Pfingst BE. Psychophysically based site selection coupled with dichotic stimulation improves speech recognition in noise with bilateral cochlear implants. J Acoust Soc Am. 2012 Aug;132(2):994-1008. doi: 10.1121/1.4730907.
citation: Zwolan TA, Collins LM, Wakefield GH. Electrode discrimination and speech recognition in postlingually deafened adult cochlear implant subjects. J Acoust Soc Am. 1997 Dec;102(6):3673-85. doi: 10.1121/1.420401.
citation: Bierer JA, Litvak L. Reducing Channel Interaction Through Cochlear Implant Programming May Improve Speech Perception: Current Focusing and Channel Deactivation. Trends Hear. 2016 Jun 17;20:2331216516653389. doi: 10.1177/2331216516653389.
citation: Srinivasan AG, Padilla M, Shannon RV, Landsberger DM. Improving speech perception in noise with current focusing in cochlear implant users. Hear Res. 2013 May;299:29-36. doi: 10.1016/j.heares.2013.02.004. Epub 2013 Mar 1.