Comparing Site-selection Strategies

Withdrawn

• Conditions: Deafness
• Interventions: Behavioral: Site selection

• Registration Number: NCT03870217
• Lead Sponsor: East Carolina University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-05
• Study First Submitted QC: 2019-03-07
• Study First Posted: 2019-03-12
• Study Start: 2020-08-01
• Primary Completion: 2023-04-04
• Study Completion: 2023-04-04
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-06-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cochlear implant users with Nucleus and AB devices	Site selection	Speech recognition will be evaluated after poor electrodes are turned off.

Primary Outcome Measures

Name	Time	Method
Speech recognition with deactivation	12 months post award notice and will take up to 3.5 years to complete	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.

Trial Locations

Locations (1)

Department of Communication Sciences and Disorders, ECU; 🇺🇸 Greenville, North Carolina, United States