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CompletedNCT06128161Updated Nov 13, 2023

Comparison of Unilateral CI vs. Bimodal Stimulation in Prosodic Perception

An observational study in Cochlear Hearing Loss, sponsored by Guy's and St Thomas' NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-13.

Sponsored by Guy's and St Thomas' NHS Foundation Trust · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
16
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Cochlear Hearing Loss
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In context

Hearing Loss, Sensorineural

375 studies on the registry are indexed under Hearing Loss, Sensorineural; 108 are open to participants now.

This study's enrollment of 16 is below the median of 78 across 95 observational studies indexed under Hearing Loss, Sensorineural.

Browse Hearing Loss, Sensorineural studies →

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust is the lead sponsor of 294 studies on the registry; 79 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients at St. Thomas' Hearing Implant Centre

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
16 participants (actual)
Patient registry
No

Interventions

  • DeviceHearing Aid

    Contralateral Hearing Aid to Cochlear Implant

06

What researchers measure

Primary outcomes

  1. PEPS-C speech test battery

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

    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

Secondary outcomes

  1. AB words speech test

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

    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

  2. SSQ12 Questionnaire

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

    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

  3. Unaided Soundfield Audiometry

    Soundfield hearing test without Cochlear Implant or Hearing Aid

    Time frame: Tested at one time point at day 1 of study after recruitment

  4. BKB sentences speech test

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

    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

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Study locations

1 site
  • Guy's and St. Thomas' NHS Foundation Trust
    London, SE1 7EH, United Kingdom
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06128161
Responsible party
Sponsor
First posted
Nov 13, 2023
Start date
Aug 30, 2022
Primary completion
Mar 23, 2023
Completion
Mar 23, 2023
Last update
Nov 13, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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