Evaluate Audiological Outcome of Cochlear Implant Program in Sohag University Hospital

NCT04719728 | Unknown

• 1 other identifier: Soh-Med-21-01-06
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hearing Loss, Sensorineural, Bilateral

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

pre lingual

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

Diagnostic Test: Aided pure tone audiometry

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

Interventions

Aided pure tone audiometry DIAGNOSTIC_TEST

aided response, speech, evoked potential

Also known as: Speech perception test, Speech in noise, P1N1 cortical evoked potential, Impedance telemetry, Electrically evoked Action Potential ECAP

post lingual; pre lingual

Eligibility Criteria

• Age: 1 Year - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Cochlear implant recipients in Sohag University Hospital

You may qualify if:

• 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.

You may not qualify if:

• none

Sponsors & Collaborators

• Sohag University: lead

Related 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.

  PMID: 28079113 BACKGROUND

MeSH Terms

Conditions

Hearing Loss

Interventions

Noise

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health; Environmental Pollution; Public Health

Study Officials

• Shahenda A Moussa, Master

  Sohag university, Faculty of medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shahenda A Moussa, Master

CONTACT

2001014489937; shahenda.abdelmaten@med.sohag.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assessment of audiological outcome of Cochlear Implant program at Sohag University Hospital

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 22, 2021
• Study Start: March 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2022
• Last Updated: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share