Comparing Site-selection Strategies

Deafness Clinical Trial

Official title:

Comparing Site-selection Strategies for Improving Speech Recognition Outcomes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03870217
• Other study ID #: Zhou_R01_study4
• Status: Terminated
• Start date: August 1, 2020
• Est. completion date: April 4, 2023

Study information

• Verified date: April 2023
• Source: East Carolina University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: April 4, 2023
• Est. primary completion date: April 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness

Intervention

Behavioral:
• Site selection
Turning off electrodes on the electrode array based on imaging and psychophysical measures

Locations

Country	Name	City	State
United States	Department of Communication Sciences and Disorders, ECU	Greenville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
East Carolina University

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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