Preoperative Variables Affecting Outcome Of Cochlear Implant

NCT03719963 | Unknown

• 1 other identifier: 17200178I
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Cochlear implants (CIs) represent one of the most important achievements of modern medicine as, for the first time in history, an electronic device is able to restore a lost sense - hearing. As of December 2012, approximately 324,200 cochlear implants have been implanted worldwide. In the United States, roughly 58,000 devices have been implanted in adults and 38,000 in children . The aim of this study is to assess the factors affecting the audiological, speech and language outcomes achieved by the recipients of multi-channel cochlear implants.

Conditions

Speech Cortex Disorder

Outcome Measures

Primary Outcomes (1)

• speech cortical evoked potential

  Intelligent hearing system is the name of the instrument that will be used,speech stimulus that will used,cortical p1 and N1 waves that will be detected which is the outcome that we need to measure

  1 year

Study Arms (1)

cochlear implant

Cochlear implantation is a powerful tool for helping children with severe to profound sensorineural hearing loss to gain the ability to hear, and to achieve age appropriate communication skills. Evaluating the development of auditory, speech, language skills and the personality of implanted child is useful for the parent, the teacher, the therapist, and the subsequent rehabilitation progress

Device: Cochlear implant

Interventions

Cochlear implant DEVICE

Cochlear implant for hearing process by surgical intervention

cochlear implant

Eligibility Criteria

• Age: Up to 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Age less than 6years at time of implantation with history of cochlear implant

You may qualify if:

• a) Children with bilateral severe to profound sensorineural hearing loss. b) Age less than 6 years at time of implantation. c) Prelingual deafness

You may not qualify if:

• Incomplete follow up.
• post lingual children
• children with special needs such as mental retardation or autism

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• Holt RF, Svirsky MA. An exploratory look at pediatric cochlear implantation: is earliest always best? Ear Hear. 2008 Aug;29(4):492-511. doi: 10.1097/AUD.0b013e31816c409f.

  PMID: 18382374 RESULT

MeSH Terms

Interventions

Cochlear Implants

Intervention Hierarchy (Ancestors)

Neural Prostheses; Implantable Neurostimulators; Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants; Hearing Aids; Sensory Aids

Study Officials

• Assiut university Faculty of medicine, University

  www.emro.who.int/unified-medical -dictionary.html

  STUDY CHAIR

Central Study Contacts

Nashwa Mr Ameer Mahmoud, Master

CONTACT

00201000445830; Nashwa_ameer88@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: June 2, 2018
• First Posted: October 25, 2018
• Study Start: December 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: June 1, 2019
• Last Updated: October 25, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: 9-2018 for 6 months
• Access Criteria: yes a agree to accrss