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Clinical Trials/NCT06128161
NCT06128161
Completed
Not Applicable

Comparison of Unilateral CI vs. Bimodal Stimulation in Prosodic Perception

Guy's and St Thomas' NHS Foundation Trust1 site in 1 country16 target enrollmentAugust 30, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cochlear Hearing Loss
Sponsor
Guy's and St Thomas' NHS Foundation Trust
Enrollment
16
Locations
1
Primary Endpoint
PEPS-C speech test battery
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

An observational study to determine and assess perception of prosodic information in adults who use bimodal stimulation (cochlear implant plus hearing aid) when using both devices vs. cochlear implant alone.

Detailed Description

People with severe to profound hearing loss often do not get satisfactory benefit from their hearing aids. A cochlear implant (CI) is a prosthetic device for the inner ear which can directly stimulate the auditory nerve, bypassing damaged inner ear hair cells and thus provide audible sensations to profoundly deaf patients. Currently, one CI is funded by NHS England for adult patients and the eligibility criteria for implantation has been relaxed in recent years. As a result, there are now an increasing number of unilateral CI users who possess low-frequency residual hearing in their non-implanted ear. For many patients this residual hearing may still be usefully amplified by a HA. This configuration, consisting of a CI and a contralateral HA, is known as bimodal stimulation. The PEPS-C receptive test battery has been previously used to assess prosody perception in hearing loss. The current project will use selected tests from the PEPS-C prosodic test battery to assess intonation, emotion and phrase stress perception ability in adults with bimodal stimulation using both devices together and CI alone.

Registry
clinicaltrials.gov
Start Date
August 30, 2022
End Date
March 23, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Has unilateral Cochlear Implant
  • Consistent use of Hearing Aid
  • Obtains some benefit in speech discrimination from hearing aid (\> 20% AB words)
  • Post-lingually deafened
  • Fluent English

Exclusion Criteria

  • Longstanding significant asymmetry (\> 20 dB HL 4 frequency average) in hearing where the unimplanted ear is the worse ear
  • Inconsistent Hearing Aid use
  • Significant conductive hearing loss (\> 20 dB HL 4 frequency average)
  • Using Electro-Acoustic stimulation Cochlear Implant
  • Aetiology of hearing loss likely associated with auditory neuropathy
  • Significantly abnormal appearance of cochlea or cochlear nerve

Outcomes

Primary Outcomes

PEPS-C speech test battery

Time Frame: Tested at one time point at day 1 of study after recruitment in both Cochlear Implant Alone and Cochlear Implant and Hearing Aid Together conditions

Test battery of 7 speech tests examining prosodic elements of speech, each section scored out of 16 (112 in total higher scores better outcome)

Secondary Outcomes

  • AB words speech test(Tested at one time point at day 1 of study after recruitment in both Cochlear Implant Alone and Cochlear Implant and Hearing Aid Together conditions)
  • SSQ12 Questionnaire(Tested at one time point at day 1 of study after recruitment in both Cochlear Implant Alone and Cochlear Implant and Hearing Aid Together conditions)
  • BKB sentences speech test(Tested at one time point at day 1 of study after recruitment in both Cochlear Implant Alone and Cochlear Implant and Hearing Aid Together conditions)
  • Unaided Soundfield Audiometry(Tested at one time point at day 1 of study after recruitment)

Study Sites (1)

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