Bimodal Stimulation Compared to Unilateral Cochlear Implant

NCT04093830 | Unknown

• 1 other identifier: bimodal hearing
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 .

Conditions

Hearing Impaired Children

Keywords

Hearing Loss

Outcome Measures

Primary Outcomes (5)

• Comparison the audiometric thresholds in bimodal fitting users condition and cochlear implant alone condition

  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.

  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

  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

  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.

  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

Study Arms (1)

pre-lingually deafened children with cochlear implant

EXPERIMENTAL

pre-lingually deafened children with cochlear implant who continuously used bimodal hearing.

Device: hearing aid

Interventions

hearing aid DEVICE

hearing aid can be used in their non- implanted ear with residual hearing

pre-lingually deafened children with cochlear implant

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The lack of middle-ear infection.
• Normative intelligence.
• The lack of auditory neuropathy disorder .
• Residual hearing in the non-implanted ear.

You may not qualify if:

• Middle ear infection..
• Below average intelligence.
• Auditory neuropathy disorder.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• Dorman MF, Gifford RH, Spahr AJ, McKarns SA. The benefits of combining acoustic and electric stimulation for the recognition of speech, voice and melodies. Audiol Neurootol. 2008;13(2):105-12. doi: 10.1159/000111782. Epub 2007 Nov 29.

  PMID: 18057874 BACKGROUND

• Kokkinakis K, Pak N. Binaural advantages in users of bimodal and bilateral cochlear implant devices. J Acoust Soc Am. 2014 Jan;135(1):EL47-53. doi: 10.1121/1.4831955.

  PMID: 24437856 BACKGROUND

• Tao DD, Liu JS, Yang ZD, Wilson BS, Zhou N. Bilaterally Combined Electric and Acoustic Hearing in Mandarin-Speaking Listeners: The Population With Poor Residual Hearing. Trends Hear. 2018 Jan-Dec;22:2331216518757892. doi: 10.1177/2331216518757892.

  PMID: 29451107 BACKGROUND

MeSH Terms

Conditions

Hearing Loss

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Sensory Aids

Study Officials

• Enass S Mohamed, Professor

  Professor of Audio-vestibular medicine,Assiut University,Egypt.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariam R Fam, Resident

CONTACT

01008630890; mariamrizkfam@gmail.com

Amira M Eloseily, Lecturer

CONTACT

01095495110; amiraos@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor -Assiut university hospital-Assiut

Study Record Dates

• First Submitted: September 6, 2019
• First Posted: September 18, 2019
• Study Start: June 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: January 1, 2022
• Last Updated: January 18, 2020

Record last verified: 2020-01