Bimodal Stimulation Compared to Unilateral Cochlear Implant

January 16, 2020 updated by: Mariam Rizk Fam, Assiut University

Advantages of Bimodal Stimulation Compared to Unilateral Cochlear Implant Use in Children With Hearing Loss

The majority of studies about bimodal hearing advantages have been conducted on adults but scant relevant studies into pediatric users, therefore more comparative studies are required to compare the effect of bimodal stimulation to unilateral cochlear implant use in children with severe to profound sensori-neural hearing loss .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

There are now many recipients of unilateral cochlear implants who have usable residual hearing in the non-implanted ear. To avoid auditory deprivation and to provide binaural hearing, a hearing aid or a second cochlear implant can be fitted to that ear. When bilateral cochlear implant cannot be used for patients with bilateral hearing impairment, a hearing aid can be used in their non- implanted ear with residual hearing. This is because patients with bilateral hearing loss need bilateral stimulation to develop the neural pathway required for central processing of binaural hearing.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

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

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

Ages Eligible for Study

5 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The lack of middle-ear infection.
  2. Normative intelligence.
  3. The lack of auditory neuropathy disorder .
  4. Residual hearing in the non-implanted ear.

Exclusion Criteria:

  1. Middle ear infection..
  2. Below average intelligence.
  3. Auditory neuropathy disorder.

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pre-lingually deafened children with cochlear implant
pre-lingually deafened children with cochlear implant who continuously used bimodal hearing.
Device: hearing aid
hearing aid can be used in their non- implanted ear with residual hearing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison the audiometric thresholds in bimodal fitting users condition and cochlear implant alone condition
Time Frame: Baseline
By using pure tone and speech audiometer the pure tone audiometry will be done in the free field with a speaker at 0° azimuth and the mean threshold in speech frequencies of 0.5, 1, 2 and 4 kilohertz will be determined.
Baseline
Comparison between speech discrimination score in bimodal fitting condition and cochlear implant alone condition.
Time Frame: Baseline

The speech discrimination score is a measure as a percentage of words from a standardized list presented at suprathreshold levels that are recognized and repeated by the patient.

a higher score on the speech discrimination test is better

Interpreting speech discrimination score :

100-90% Means Excellent or Normal speech discrimination score, 89-75% Means Good speech discrimination score, 74-60% Means Fair speech discrimination score, 59-50 % Means Poor speech discrimination score& <50% Means Very Poor speech discrimination score.
Baseline
Evaluation of speech perception ability in noise under bimodal fitting a condition and cochlear implant alone condition
Time Frame: Baseline
By speech perception in noise (SPIN) test using Compact disc on compact discs player.
Baseline
Comparison of early speech perception in bimodal fitting condition and cochlear implant alone condition
Time Frame: Baseline
The test will be done starting from a low level using the manual and standard scoring forms of Early speech perception test ( ESP) by using : Compact disc , full-color picture cards, Toys ,digitally remastered sounds, and an All Words menu
Baseline
Comparison between the speech reception threshold in bimodal fitting condition and cochlear implant alone condition.
Time Frame: Baseline
Speech reception threshold is the minimum intensity in decibels at which a patient can understand 50% of spoken words from a closed set list of disyllabic words
Baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Principal Investigator: Enass S Mohamed, Professor, Professor of Audio-vestibular medicine,Assiut University,Egypt.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

June 1, 2020

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

September 6, 2019

First Submitted That Met QC Criteria

September 14, 2019

First Posted (Actual)

September 18, 2019

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 16, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • bimodal hearing

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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