Clinical trial NCT04719728: Evaluate Audiological Outcome of Cochlear Implant Program in Sohag University Hospital
Official title: Assessment of Audiological Outcome of Cochlear Implant Program at Sohag University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hearing Loss, Sensorineural, Bilateral
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cochlear implant recipients in Sohag University Hospital

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.

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

Primary outcomes:
measure: Hearing threshold for Cochlear implant users at Sohag University Hospital
timeFrame: one year postoperative
measure: Central processing of speech for cochlear implant users at Sohag university Hospital
timeFrame: one year postoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sohag university, Faculty of medicine
name: Shahenda A Moussa, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.