Comparing Site-selection Strategies

NCT03870217 | Withdrawn

• 1 other identifier: Zhou_R01_study4
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Deafness

Outcome Measures

Primary Outcomes (1)

• Speech recognition with deactivation

  Electrodes will be evaluated based on (1) pitch discrimination (2) focused thresholds (3) amplitude modulation detection thresholds and (4) distances from the modious. Electrodes will be deactivated based on each of these measures and speech recognition will be evaluated to assess the effect of deactivation. The benefit of deactivation (speech recognition after deactivation minus before deactivation) will be derived for each measure. The measure that produces the greatest benefit will be identified.

  12 months post award notice and will take up to 3.5 years to complete

Study Arms (1)

Cochlear implant users with Nucleus and AB devices

Speech recognition will be evaluated after poor electrodes are turned off.

Behavioral: Site selection

Interventions

Site selection BEHAVIORAL

Turning off electrodes on the electrode array based on imaging and psychophysical measures

Cochlear implant users with Nucleus and AB devices

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Children and adults with cochlear implants

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• East Carolina University: lead

Study Sites (1)

Department of Communication Sciences and Disorders, ECU

Greenville, North Carolina, 27834, United States

Location

Related Publications (12)

• 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.

  PMID: 27758152 BACKGROUND

• 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.

  PMID: 23881208 BACKGROUND

• 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.

  PMID: 9334769 BACKGROUND

• 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.

  PMID: 2729822 BACKGROUND

• 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.

  PMID: 23529109 BACKGROUND

• 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.

  PMID: 25120196 BACKGROUND

• 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.

  PMID: 27798658 BACKGROUND

• 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.

  PMID: 28372106 BACKGROUND

• 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.

  PMID: 22894220 BACKGROUND

• 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.

  PMID: 9407659 BACKGROUND

• 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.

  PMID: 27317668 BACKGROUND

• 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.

  PMID: 23467170 BACKGROUND

MeSH Terms

Conditions

Deafness

Interventions

Bud13 protein, S cerevisiae

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

• Ning Zhou, PHD

  East Carolina University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 12, 2019
• Study Start: August 1, 2020
• Primary Completion: April 4, 2023
• Study Completion: April 4, 2023
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)