Evaluate Audiological Outcome of Cochlear Implant Program in Sohag University Hospital

Assessment of Audiological Outcome of Cochlear Implant Program at Sohag University Hospital

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.

Study Overview

• Status: Unknown
• Conditions: Hearing Loss, Sensorineural, Bilateral
• Intervention / Treatment: Diagnostic test: Aided pure tone audiometry

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Shahenda A Moussa, Master; Phone Number: 2001014489937; Email: shahenda.abdelmaten@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Cochlear implant recipients in Sohag University Hospital

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
pre lingual; aided response, speech perception threshold impedance telemetry electrically evoked action potential p1n1 cortical evoked potential	Diagnostic test: Aided pure tone audiometry; aided response, speech, evoked potential; Other Names: Speech perception test; Speech in noise; P1N1 cortical evoked potential; Impedance telemetry; Electrically evoked Action Potential ECAP
post lingual; aided response, speech perception threshold speech in noise impedance telemetry electrically evoked action potential p1n1 cortical evoked potential	Diagnostic test: Aided pure tone audiometry; aided response, speech, evoked potential; Other Names: Speech perception test; Speech in noise; P1N1 cortical evoked potential; Impedance telemetry; Electrically evoked Action Potential ECAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hearing threshold for Cochlear implant users at Sohag University Hospital	Pure Tone Audiometery will be used to measure the hearing threshold in decible at each frequnecy from 250 Hz to 8000 Hz	one year postoperative
Central processing of speech for cochlear implant users at Sohag university Hospital	Auditory Evoked Potential for detection of P1 wave which generated at central auditory area, Presence of P1 wave means normal speech processing, while absence of P1 wave means abnormal speech processing	one year postoperative

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Principal Investigator: Shahenda A Moussa, Master, Sohag University, Faculty of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: January 19, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 19, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Hearing Loss, Sensorineural
• Other Study ID Numbers: Soh-Med-21-01-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No