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Evaluate Audiological Outcome of Cochlear Implant Program in Sohag University Hospital

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04719728
Collaborator
(none)
100
Enrollment
12
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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.

  1. 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.

  1. 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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Assessment of Audiological Outcome of Cochlear Implant Program at Sohag University Hospital
Anticipated Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Hearing threshold for Cochlear implant users at Sohag University Hospital [one year postoperative]

      Pure Tone Audiometery will be used to measure the hearing threshold in decible at each frequnecy from 250 Hz to 8000 Hz

    2. Central processing of speech for cochlear implant users at Sohag university Hospital [one year postoperative]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sohag University

    Investigators

    • Principal Investigator: Shahenda A Moussa, Master, Sohag university, Faculty of medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Shahenda Abdelmateen Moussa, Assessment of audiological outcome of Cochlear Implant program at Sohag University Hospital, Sohag University
    ClinicalTrials.gov Identifier:
    NCT04719728
    Other Study ID Numbers:
    • Soh-Med-21-01-06
    First Posted:
    Jan 22, 2021
    Last Update Posted:
    Jan 22, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hearing Loss
    Hearing Loss, Sensorineural

    Study Results

    No Results Posted as of Jan 22, 2021