NCT05275712

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 11, 2022

Completed
12 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

February 22, 2023

Status Verified

March 1, 2022

Enrollment Period

2 months

First QC Date

March 1, 2022

Last Update Submit

February 21, 2023

Conditions

Cochlear Implant

Outcome Measures

Primary Outcomes (2)

  • 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

  • Speech perception test with figures

    2 years

Interventions

Audiological evaluationOTHER

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

Eligibility Criteria

Age4 Years - 14 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children between 4 to 14 years underwent cochlear implantation surgery between 2015 and 2022 in audiovestibular unit at Assiut University Hospital.

You may qualify if:

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

You may not qualify if:

  • Patients with irregular device use.
  • Implantation less than 6 months.
  • Patients who refused to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 26584722BACKGROUND

  • 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.

    PMID: 23415572BACKGROUND

  • 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.

    PMID: 20407059BACKGROUND

  • 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.

    PMID: 22115689BACKGROUND

  • 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.

    PMID: 18057340BACKGROUND

  • 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.

    PMID: 32643593BACKGROUND

  • 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.

    PMID: 21493349BACKGROUND

Central Study Contacts

Sally Shenouda Bolis, Master

CONTACT

+201552431299sallyshenouda1993@gmail.com

Amal Mohamed Hussein EL Attar, Prof

CONTACT

+201003676677amalelattar99@Yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

March 1, 2022

First Posted

March 11, 2022

Study Start

March 1, 2023

Primary Completion

May 1, 2023

Study Completion

July 1, 2023

Last Updated

February 22, 2023

Record last verified: 2022-03