Comparison of Unilateral CI vs. Bimodal Stimulation in Prosodic Perception

Sponsor
Guy's and St Thomas' NHS Foundation Trust (Other)
Overall Status
Completed
CT.gov ID
NCT06128161
Collaborator
University of Manchester (Other)
16
1
6.7
2.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Hearing Aid

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.

Study Design

Study Type:
Observational
Actual Enrollment :
16 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Comparison of Unilateral CI vs. Bimodal Stimulation in Prosodic Perception
Actual Study Start Date :
Aug 30, 2022
Actual Primary Completion Date :
Mar 23, 2023
Actual Study Completion Date :
Mar 23, 2023

Outcome Measures

Primary Outcome Measures

  1. PEPS-C speech test battery [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 Outcome Measures

  1. 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]

    Word speech discrimination test in quiet, 30 words presented, scored as % correct, higher score better outcome

  2. 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]

    Speech Spatial Qualities patient reported outcome measure, scored out of 120 higher scores better outcome

  3. Unaided Soundfield Audiometry [Tested at one time point at day 1 of study after recruitment]

    Soundfield hearing test without Cochlear Implant or Hearing Aid

  4. 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]

    Sentences speech discrimination test in quiet, 100 words presented, 50 male, 50 female voice, scored as %

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Adult

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Guy's and St. Thomas' NHS Foundation Trust London United Kingdom SE1 7EH

Sponsors and Collaborators

  • Guy's and St Thomas' NHS Foundation Trust
  • University of Manchester

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT06128161
Other Study ID Numbers:
  • 307417
First Posted:
Nov 13, 2023
Last Update Posted:
Nov 13, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 13, 2023