Comparison of Unilateral CI vs. Bimodal Stimulation in Prosodic Perception

November 9, 2023 updated by: Guy's and St Thomas' NHS Foundation Trust
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients at St. Thomas' Hearing Implant Centre

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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
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
Time Frame: Tested at one time point at day 1 of study after recruitment
Soundfield hearing test without Cochlear Implant or Hearing Aid
Tested at one time point at day 1 of study after recruitment
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 %
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guy's and St Thomas' NHS Foundation Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Manchester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 23, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 23, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 307417

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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