Clinical trial NCT04722042: Place-based Mapping in EAS Listeners
Official title: Place-based Mapping in Electric-acoustic Stimulation Listeners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cochlear Implant
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2021-01-25
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized to one of two groups.
Primary purpose: TREATMENT

Brief summary: Purpose: Investigate monaural and binaural hearing in electric-acoustic stimulation (EAS) users with place-based versus default maps.

Participants: Cochlear implant recipients and normal-hearing listeners Procedures (methods): This is a prospective, longitudinal investigation of the monaural and binaural outcomes (such as speech perception, spatial hearing, and/or subjective benefit) of cochlear implant recipients listening with different programs. The programs will incorporate different patient and device variables to determine the effect on cochlear implant recipient outcomes.


Eligibility criteria: Cochlear implant participants

Inclusion Criteria:

* 18-80 years of age at implantation, identify English as native language, Medical Electronics (MED-EL) array recipient, and a postoperative unaided detection threshold of less than or equal to 65 decibel (dB) hearing level (HL) at 125 Hz

Exclusion Criteria:

* Report or present with a cognitive delay or impairment

Normal-hearing controls

Inclusion Criteria:

* 18-80 years of age at time of testing, unaided detection thresholds of 35 dB HL or better from 500-4000 Hz, identify English as native language

Exclusion Criteria:

* Report or present with a cognitive delay or impairment

Primary outcomes:
measure: Monaural Perception for Participants With Cochlear Implants (Arms 1 and 2) Over Time
timeFrame: Up to 12 months post-activation
measure: Binaural Hearing Abilities Over Time (Noise to the Study Ear Minus Noise From the Front)
timeFrame: Up to 12 months post-activation
measure: Binaural Hearing Abilities Over Time (Noise to the Non-study Ear Minus Noise From the Front)
timeFrame: Up to 12 months post-activation
Secondary outcomes:
measure: Perceived Abilities Over Time
timeFrame: Up to 12 months post-activation
Other outcomes:
measure: Word Recognition With Default Versus Place-based Maps for Participants With Normal Hearing
timeFrame: All procedures completed at baseline (one visit that was ~ 20 minutes in duration).
measure: Vowel Recognition for Participants With Normal Hearing
timeFrame: All procedures completed at baseline (one visit that was ~ 20 minutes in duration).
measure: Sentence Understanding in Noise for Participants With Normal Hearing
timeFrame: All procedures completed at baseline (one visit that was ~ 20 minutes in duration).
Locations:
city: Chapel Hill
country: United States
facility: UNC ENT at Carolina Crossing
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Margaret T Dillon, AuD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Kevin D Brown, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dillon MT, Canfarotta MW, Buss E, Rooth MA, Richter ME, Overton AB, Roth NE, Dillon SM, Raymond JH, Young A, Pearson AC, Davis AG, Dedmon MM, Brown KD, O'Connell BP. Influence of Electric Frequency-to-Place Mismatches on the Early Speech Recognition Outcomes for Electric-Acoustic Stimulation Users. Am J Audiol. 2023 Mar;32(1):251-260. doi: 10.1044/2022_AJA-21-00254. Epub 2023 Feb 17.
citation: Dillon MT, O'Connell BP, Canfarotta MW, Buss E, Hopfinger J. Effect of Place-Based Versus Default Mapping Procedures on Masked Speech Recognition: Simulations of Cochlear Implant Alone and Electric-Acoustic Stimulation. Am J Audiol. 2022 Jun 2;31(2):322-337. doi: 10.1044/2022_AJA-21-00123. Epub 2022 Apr 8.
citation: Dillon MT, Canfarotta MW, Buss E, Hopfinger J, O'Connell BP. Effectiveness of Place-based Mapping in Electric-Acoustic Stimulation Devices. Otol Neurotol. 2021 Jan;42(1):197-202. doi: 10.1097/MAO.0000000000002965.