Evaluate Audiological Outcome of Cochlear Implant Program in Sohag University Hospital

NCT ID: NCT04719728

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2022-03-01

Brief Summary

Evaluation of the outcome of cochlear implantation (CI) is very important issue since adequate hearing is linked to improved communication outcomes and school performance, development of speech and language, enhances speech perception in quiet and noise and even allows CI recipients to use the telephone.

As well as there is a growing need for a widely used set of international quality standards on minimal outcome measurements to determine outcomes in CI recipients, monitor the auditory progress of CI recipients over time and to be able to relate on important issues as the most ideal age for implantation and the cut-off audiological thresholds for CI indication.

This study will be conducted to evaluate outcome of cochlear implantation in sohag university hospital.

Aim of work:

To evaluate the outcome of cochlear implantation in Sohag university hospital.

Detailed Description

Materials and Methods:

• It is a prospective study on cochlear implant recipients in sohag cochlear implant unite from 2014: 2020.

• Subjects: Cochlear implant recipients in sohag cochlear implant unite from 2014: 2020.

Subjects will be divided into 2 categories:

1. Prelingual patients: subdivided into 3 groups

• Cochlear implant recipient with no medical or radiological issues.
• Cochlear implant recipients with medical concern or with other disabilities as syndromic patients.
• Cochlear implant recipients with radiological issues.

2. Postlingual patients: subdivided into 3 groups

• Cochlear implant recipients with no medical or radiological issues.
• Cochlear implant recipients with medical concern or with other disabilities as syndromic patients.
• Cochlear implant recipients with radiological issues.

Inclusion criteria:

Patients who received cochlear implant at Sohag university hospital and fulfill the following criteria:

• Age: from one year up to 60.
• Prelingual who had one year of regular speech therapy
• Postlingual patients.

• Method:

1. Background information:

• History: Age, gender, Age at which hearing loss occur, cause of hearing loss, duration of hearing loss.
• Family support.
• Expectation of patient (if post lingual patient).
• Expectation of parents.

2. Hearing assessment:

• Aided Pure Tone Audiometry (PTA) level.
• Speech perception

1. speech perception threshold (SRT).

2. Speech perception in quiet for patients who developed language and postlingual patients using phonetically Balanced words for kinder garden ( PBKG) words, phonetically balanced words for adult (PBA), word intelligibility by picture identification (WIPI) or minimal birds.

3. Speech in noise test: for patients who developed language and post lingual patients.

3- Impedance telemetry. 4- Electrically evoked action potential (ECAP). 5- Cortical evoked P1N1 potential. Informed written consent will be taken from all Participant patients or their legal guardians.

This search will submit for approval from Research Ethics committee of Sohag Faculty of medicine.

All investigation will be done cost free.

Conditions

Hearing Loss, Sensorineural, Bilateral

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

pre lingual

aided response, speech perception threshold impedance telemetry electrically evoked action potential p1n1 cortical evoked potential

Aided pure tone audiometry

Intervention Type: DIAGNOSTIC_TEST

aided response, speech, evoked potential

post lingual

aided response, speech perception threshold speech in noise impedance telemetry electrically evoked action potential p1n1 cortical evoked potential

Aided pure tone audiometry

Intervention Type: DIAGNOSTIC_TEST

aided response, speech, evoked potential

Interventions

Aided pure tone audiometry

aided response, speech, evoked potential

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Speech perception test; Speech in noise; P1N1 cortical evoked potential; Impedance telemetry; Electrically evoked Action Potential ECAP

Eligibility Criteria

Inclusion Criteria

-

Patients who received cochlear implant at Sohag university hospital and fulfill the following criteria:

• Age: from one year up to 60.
• Prelingual who had one year of regular speech therapy
• Postlingual patients.

Exclusion Criteria

• none

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Shahenda Abdelmateen Moussa

Assessment of audiological outcome of Cochlear Implant program at Sohag University Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shahenda A Moussa, Master

Role: PRINCIPAL_INVESTIGATOR

Sohag university, Faculty of medicine

Central Contacts

Shahenda A Moussa, Master

Role: CONTACT

shahenda.abdelmaten@med.sohag.edu.eg

2001014489937

References

Korver AM, Smith RJ, Van Camp G, Schleiss MR, Bitner-Glindzicz MA, Lustig LR, Usami SI, Boudewyns AN. Congenital hearing loss. Nat Rev Dis Primers. 2017 Jan 12;3:16094. doi: 10.1038/nrdp.2016.94.

Reference Type: BACKGROUND

PMID: 28079113 (View on PubMed)

Other Identifiers

Soh-Med-21-01-06

Identifier Type: -

Identifier Source: org_study_id