Outcome of Cochlear Implant in Assiut University

February 21, 2023 updated by: Sally Shenouda Bolis, Assiut University

Outcome of Cochlear Implant in Children at Assiut University Hospital

Evaluation of the outcome of cochlear implanted children at audiovestibular medicine unit in Assiut university hospital.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Hearing loss is one of the most common health problems affecting people around the world with an average international incidence of 5% .

In Egypt, it affects 16% of the population with an incidence of 14% in children less than 14 years old. 86% of deaf patients had conductive hearing loss (CHL), while sensorineural hearing loss (SNHL) was found in 14%, with a male to female ratio of 3:2 HL .

Cochlear implantation (CI) has become a routine procedure in the United States and worldwide for the management of severe-to-profound SNHL loss. It is a remarkable example of success that was made possible through collaboration between engineers, surgeons, scientists and the medical community .

Early cochlear implantation had a long-term positive impact on auditory and verbal development, if auditory stimulation does not occur within this timeframe, the auditory system degenerates. It has been suggested that in the absence of normal auditory stimulation there is a period of about 3.5 years during which the central auditory system retains its maximum plasticity. This can extend in some children up to the age of approximately 7 years, after which it is significantly reduced. The earlier implantation causes better outcomes, including improved language development, speech perception and speech production skills .

Early research reviews found that the ability to communicate in spoken language was better the earlier the implantation was performed. These reviews also found that cochlear implants provide open set speech understanding for the majority of implanted profoundly hearing-impaired children, and that it was not possible to accurately predict the specific outcome of the given implanted child .

Research since then has reported long-term socio-economic benefits for children as well as audiological outcomes including improved sound localization and speech perception .

The outcome of CI surgery on Quality of Life (QoL) has been greatly investigated via parental questionnaire assessment. This questionnaire was designed with 11 subscales and 58 questions in total. All questions were scaled from 1 to 5: (1 strongly agree; 2 agree; 3 neither agree nor disagree; 4 disagree; and 5 strongly disagree) .

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

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

Study Contact

Study Contact Backup

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

4 years to 14 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children between 4 to 14 years underwent cochlear implantation surgery between 2015 and 2022 in audiovestibular unit at Assiut University Hospital.

Description

Inclusion Criteria:

  • Children between (4-14 years) who underwent cochlear implantation surgery between 2015 and 2022.

Both sexes will be included.

Exclusion Criteria:

  1. Patients with irregular device use.
  2. Implantation less than 6 months.
  3. Patients who refused to participate in the study.

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

Outcome Measure
Measure Description
Time Frame
Parents' perspective Questionnaire
Time Frame: 2 years
The outcome of CI surgery on Quality of Life (QoL) has been greatly investigated via parental questionnaire assessment. This questionnaire was designed with 11 subscales and 58 questions in total. All questions were scaled from 1 to 5: (1 strongly agree; 2 agree; 3 neither agree nor disagree; 4 disagree; and 5 strongly disagree)
2 years
Speech perception test with figures
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

Assiut University

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)

March 1, 2023

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

March 1, 2022

First Submitted That Met QC Criteria

March 10, 2022

First Posted (Actual)

March 11, 2022

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Outcome of cochlear implant

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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