Vestibular Cochlear Implant Hearing Impaired Child

NCT03599804 | Unknown

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

Brief Summary

Cochlear implantation (CI) is a well-known surgical procedure to rehabilitate patients with severe to profound sensorineural hearing loss. Indications for this surgery have expanded in the last 10 years including bilateral CI. Although CI has been described as a safe procedure with few major complications, it may have an adverse effect on the vestibular functions and produce dizziness. Prevalence of postoperative dizziness varies widely in the literature and is said to affect between 2% - 47%.

Conditions

Vestibular Abnormality

Keywords

Vestibular; Cochlear; Implant; Hearing; Child

Outcome Measures

Primary Outcomes (4)

• Head thrust test

  Clinical test which assesses vestibuloocular (VOR) function in which examiner briskly rotate patient's head to both sides while patient fixate his eyes on a target and watch for corrective saccades on eye movements.

  baseline

• Bruininks-Oseretsky test of motor proficiency (BOT-2)

  Clinical balance test which assesses vestibulospinal (VSR) function, patient stand on a firm surface and on a soft cushion with eyes closed and eye open, a scoring system is obtained for all these balance situations.

  baseline

• Caloric test

  Objective test of VOR, includes irrigation of warm and\\or cool water into patient's external auditory canal and measure the resulting nystagmus by a computerized system.

  baseline

• Vestibular evoked myogenic potentials (VEMPs)

  Objective test of vestibulocollic (VCR) function which assesses otolithic organs, VEMPs amplitudes and latencies are measured by a computerized system.

  baseline

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with severe to profound hearing loss aged less than 6 years and candidate for cochlear implant with no motor problems before surgery.

You may qualify if:

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

You may not qualify if:

• Incomplete follow up.
• Other pathologies affecting balance as orthopedic problems before surgery.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (9)

• Bittar RSM, Sato ES, Ribeiro DJS, Tsuji RK. Preoperative vestibular assessment protocol of cochlear implant surgery: an analytical descriptive study. Braz J Otorhinolaryngol. 2017 Sep-Oct;83(5):530-535. doi: 10.1016/j.bjorl.2016.06.014. Epub 2016 Jul 31.

  PMID: 27574724 BACKGROUND

• Krause E, Wechtenbruch J, Rader T, Gurkov R. Influence of cochlear implantation on sacculus function. Otolaryngol Head Neck Surg. 2009 Jan;140(1):108-113. doi: 10.1016/j.otohns.2008.10.008.

  PMID: 19130972 RESULT

• Todt I, Basta D, Ernst A. Does the surgical approach in cochlear implantation influence the occurrence of postoperative vertigo? Otolaryngol Head Neck Surg. 2008 Jan;138(1):8-12. doi: 10.1016/j.otohns.2007.09.003.

  PMID: 18164986 RESULT

• Kubo T, Yamamoto K, Iwaki T, Doi K, Tamura M. Different forms of dizziness occurring after cochlear implant. Eur Arch Otorhinolaryngol. 2001 Jan;258(1):9-12. doi: 10.1007/pl00007519.

  PMID: 11271438 RESULT

• Vibert D, Hausler R, Kompis M, Vischer M. Vestibular function in patients with cochlear implantation. Acta Otolaryngol Suppl. 2001;545:29-34. doi: 10.1080/000164801750388063.

  PMID: 11677737 RESULT

• Vibert D, Liard P, Hausler R. Bilateral idiopathic loss of peripheral vestibular function with normal hearing. Acta Otolaryngol. 1995 Sep;115(5):611-5. doi: 10.3109/00016489509139375.

  PMID: 8928631 RESULT

• Frazza MM. (1999): Propedèutica otoneurológica básica. In: Gananҫ, FF (coordenator). Um giro pela vertigem. Sào Paulo: Alaúde; p.21-24.

  RESULT

• Hempel JM, Jager L, Baumann U, Krause E, Rasp G. Labyrinth dysfunction 8 months after cochlear implantation: a case report. Otol Neurotol. 2004 Sep;25(5):727-9. doi: 10.1097/00129492-200409000-00014.

  PMID: 15354003 RESULT

• Katsiari E, Balatsouras DG, Sengas J, Riga M, Korres GS, Xenelis J. Influence of cochlear implantation on the vestibular function. Eur Arch Otorhinolaryngol. 2013 Feb;270(2):489-95. doi: 10.1007/s00405-012-1950-6. Epub 2012 Apr 6.

  PMID: 22481544 RESULT

Study Officials

• Enass S Mohamed, MD

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Marwa Hu Hamza, Master

CONTACT

01021101180; marwa.hamza20687@gmail.com

Enass S Mohamed, MD

CONTACT

01003362922; enasshassan40@yahoo.com.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 14, 2018
• First Posted: July 26, 2018
• Study Start: June 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2021
• Last Updated: July 26, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share