Outcome of Cochlear Implant in Assiut University

• Conditions: Cochlear Implant

• Registration Number: NCT05275712
• Lead Sponsor: Assiut University

Brief Summary

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

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 Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-01
• Study First Submitted QC: 2022-03-10
• Study First Posted: 2022-03-11
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-02-22
• Study Start: 2023-03
• Primary Completion: 2023-05
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Speech perception test with figures	2 years
Parents' perspective Questionnaire	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)