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Completed

NCT Number: NCT06128161

Comparison of Unilateral CI vs. Bimodal Stimulation in Prosodic Perception

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Guy's and St. Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hearing Aid

Device

Contralateral Hearing Aid to Cochlear Implant

Primary outcomes

  1. 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

  1. AB words speech test

    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

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

  2. SSQ12 Questionnaire

    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

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

  3. Unaided Soundfield Audiometry

    Time frame: 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

    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

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

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Collaborators

  • University of Manchester

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 13, 2023
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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