Place-based Mapping in EAS Listeners

Cochlear Implant Clinical Trial

Official title:

Place-based Mapping in Electric-acoustic Stimulation Listeners

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04722042
• Other study ID #: 20-3022
• Secondary ID: R21DC018389
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 23, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cochlear Implant

Intervention

Other:
• place-based mapping
Adjusting the electric frequency filters to align with the cochlear place frequency
• default mapping
Default frequency filter assignments

Locations

Country	Name	City	State
United States	UNC ENT at Carolina Crossing	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monaural perception over time	Monaural perception (e.g., word recognition in quiet) will be assessed at defined intervals (e.g., activation, and 1, 3, 6, and 12 months post-activation). Performance (e.g., percent correct) will be compared within-subject and between group over the study intervals.	Up to 12 months post-activation
Primary	Binaural hearing abilities over time	Binaural hearing abilities (e.g., spatial release from masking) will be assessed at defined intervals (e.g., 1, 3, 6, and 12 months post-activation). Performance (e.g., percent correct) will be compared within-subject and between group over the study intervals.	Up to 12 months post-activation
Secondary	Perceived abilities over time	Perceived abilities will be assessed with questionnaires (e.g., Speech, Spatial, and Qualities of hearing scale; SSQ) at defined intervals (e.g., activation, and 1, 3, 6, and 12 months post-activation). A subject indicates his/her perceived abilities for each question on the SSQ using a Likert scale, with a range of 0-10 (with 10 indicating better perceived abilities). Responses will be compared between group over the study intervals.	Up to 12 months post-activation