Evaluate Audiological Outcome of Cochlear Implant Program in Sohag University Hospital

Hearing Loss, Sensorineural, Bilateral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04719728
• Other study ID #: Soh-Med-21-01-06
• Status: Not yet recruiting
• Start date: March 1, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: January 2021
• Source: Sohag University
• Contact: Shahenda A Moussa, Master
• Phone: 2001014489937
• Email: shahenda.abdelmaten[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Sensorineural
• Hearing Loss, Sensorineural, Bilateral

Intervention

Diagnostic Test:
• Aided pure tone audiometry
aided response, speech, evoked potential

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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