Outcome of Cochlear Implant in Assiut University

Cochlear Implant Clinical Trial

Official title:

Outcome of Cochlear Implant in Children at Assiut University Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05275712
• Other study ID #: Outcome of cochlear implant
• Status: Not yet recruiting
• Start date: March 2023
• Est. completion date: July 2023

Study information

• Verified date: March 2022
• Source: Assiut University
• Contact: Sally Shenouda Bolis, Master
• Phone: +201552431299
• Email: sallyshenouda1993[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Evaluation of the outcome of cochlear implanted children at audiovestibular medicine unit in Assiut university hospital.

Description:

Hearing loss is one of the most common health problems affecting people around the world with an average international incidence of 5% . In Egypt, it affects 16% of the population with an incidence of 14% in children less than 14 years old. 86% of deaf patients had conductive hearing loss (CHL), while sensorineural hearing loss (SNHL) was found in 14%, with a male to female ratio of 3:2 HL . Cochlear implantation (CI) has become a routine procedure in the United States and worldwide for the management of severe-to-profound SNHL loss. It is a remarkable example of success that was made possible through collaboration between engineers, surgeons, scientists and the medical community . Early cochlear implantation had a long-term positive impact on auditory and verbal development, if auditory stimulation does not occur within this timeframe, the auditory system degenerates. It has been suggested that in the absence of normal auditory stimulation there is a period of about 3.5 years during which the central auditory system retains its maximum plasticity. This can extend in some children up to the age of approximately 7 years, after which it is significantly reduced. The earlier implantation causes better outcomes, including improved language development, speech perception and speech production skills . Early research reviews found that the ability to communicate in spoken language was better the earlier the implantation was performed. These reviews also found that cochlear implants provide open set speech understanding for the majority of implanted profoundly hearing-impaired children, and that it was not possible to accurately predict the specific outcome of the given implanted child . Research since then has reported long-term socio-economic benefits for children as well as audiological outcomes including improved sound localization and speech perception . The outcome of CI surgery on Quality of Life (QoL) has been greatly investigated via parental questionnaire assessment. This questionnaire was designed with 11 subscales and 58 questions in total. All questions were scaled from 1 to 5: (1 strongly agree; 2 agree; 3 neither agree nor disagree; 4 disagree; and 5 strongly disagree) .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: July 2023
• Est. primary completion date: May 2023
• Gender: All
• Age group: 4 Years to 14 Years

Eligibility

Inclusion Criteria:

• Children between (4-14 years) who underwent cochlear implantation surgery between 2015 and 2022. Both sexes will be included.

Exclusion Criteria:

1. Patients with irregular device use.

2. Implantation less than 6 months.

3. Patients who refused to participate in the study.

Related Conditions & MeSH terms

• Cochlear Implant

Intervention

Other:
• Audiological evaluation
Questionnaire for parents about their children behavior after implantation, audiological evaluation and speech perception test .

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (7)

Ganek H, McConkey Robbins A, Niparko JK. Language outcomes after cochlear implantation. Otolaryngol Clin North Am. 2012 Feb;45(1):173-85. doi: 10.1016/j.otc.2011.08.024. Epub 2011 Oct 19. — View Citation

Hendriksma M, Bruijnzeel H, Bezdjian A, Kay-Rivest E, Daniel SJ, Topsakal V. Quality of life (QoL) evaluation of children using cochlear implants: agreement between pediatric and parent proxy-QoL reports. Cochlear Implants Int. 2020 Nov;21(6):338-343. doi: 10.1080/14670100.2020.1788858. Epub 2020 Jul 9. — View Citation

Mulwafu W, Kuper H, Ensink RJ. Prevalence and causes of hearing impairment in Africa. Trop Med Int Health. 2016 Feb;21(2):158-65. doi: 10.1111/tmi.12640. Epub 2015 Dec 14. — View Citation

Niparko JK, Tobey EA, Thal DJ, Eisenberg LS, Wang NY, Quittner AL, Fink NE; CDaCI Investigative Team. Spoken language development in children following cochlear implantation. JAMA. 2010 Apr 21;303(15):1498-506. doi: 10.1001/jama.2010.451. — View Citation

Papsin BC, Gordon KA. Cochlear implants for children with severe-to-profound hearing loss. N Engl J Med. 2007 Dec 6;357(23):2380-7. doi: 10.1056/NEJMct0706268. No abstract available. — View Citation

Patrick DL, Edwards TC, Skalicky AM, Schick B, Topolski TD, Kushalnagar P, Leng M, O'Neill-Kemp AM, Sie KS. Validation of a quality-of-life measure for deaf or hard of hearing youth. Otolaryngol Head Neck Surg. 2011 Jul;145(1):137-45. doi: 10.1177/0194599810397604. — View Citation

Semaan MT, Fredman ET, Shah JR, Fares SA, Murray GS, Megerian CA. Surgical duration of cochlear implantation in an academic university-based practice. Am J Otolaryngol. 2013 Sep-Oct;34(5):382-7. doi: 10.1016/j.amjoto.2013.01.013. Epub 2013 Feb 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parents' perspective Questionnaire	The outcome of CI surgery on Quality of Life (QoL) has been greatly investigated via parental questionnaire assessment. This questionnaire was designed with 11 subscales and 58 questions in total. All questions were scaled from 1 to 5: (1 strongly agree; 2 agree; 3 neither agree nor disagree; 4 disagree; and 5 strongly disagree)	2 years
Primary	Speech perception test with figures		2 years