Vestibular Cochlear Implant Hearing Impaired Child

Vestibular Abnormality Clinical Trial

Official title:

Vestibular Function in Cochlear Implanted Hearing Impaired Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03599804
• Other study ID #: VCIHIC
• Status: Not yet recruiting
• Start date: June 2019
• Est. completion date: June 2021

Study information

• Verified date: July 2018
• Source: Assiut University
• Contact: Marwa Hu Hamza, Master
• Phone: 01021101180
• Email: marwa.hamza20687[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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%.

Description:

The structural and functional integrity of the vestibular system is necessary for maintenance of the complex postural system and adaptation to the environment. The absence of vestibular function is accompanied by poor prognosis and severe limitations in the activities of daily life, such as ambulating in low-light environments or on uneven ground, swimming, driving fast, etc.

The exact mechanisms responsible for the postoperative vestibular changes and/or symptoms, but several theories exist. Because of the very anatomic proximity between the auditory and vestibular systems, and their embryologic and physiologic alterations, they may be simultaneously involved in some bodily dysfunctions. This involvement is more frequent in peripheral alterations than in central ones.

The lateral wall and the fluid space are breached during cochleostomy. Insertion of electrode array may cause changes in the normal fluid homeostasis of the inner ear, damage to the basilar membrane, osseous spiral lamina and vestibular receptors; utricle, saccule and semicircular canals, surgery-induced inflammation resulting in fibrosis or loss of hair cells, foreign body reaction (labyrinthitis), produce perilymph leakage and alter the pressure in the inner ear. In addition, the electric stimulation of the cochlear implant may cause pathologic changes in the inner ear as a subsequent dysfunction of structures, resulting in vestibular alterations.

In previous research, the following vestibular assessments were utilized to determine vestibular injuries after CI: Caloric response, videonystagmography (VNG), vestibular-evoked myogenic potentials (VEMPs), video head impulse test (VHIT), rotatory chair and scleral search coil.

Knowledge of vestibular system function before and after CI surgery is important for the satisfactory management of each case. It also helps in the selection of which ear to implant to avoid bilateral vestibular areflexia and can assist in the management of any postoperative vestibular symptoms. So, there are two questions that should be raised when we consider the vestibular function of a patient who will submitted to CI: Is vestibular function present or not? and is the function symmetric?

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 2021
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 6 Years

Eligibility

Inclusion Criteria:

1. Children with bilateral severe to profound sensorineural hearing loss.

2. Age less than 6years at time of implantation.

3. Prelingual deafness.

Exclusion Criteria:

• Incomplete follow up.

• Other pathologies affecting balance as orthopedic problems before surgery.

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Vestibular Abnormality

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & 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. — View Citation

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

Hempel JM, Jäger 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. — View Citation

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. — View Citation

Krause E, Wechtenbruch J, Rader T, Gürkov 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. — View Citation

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. — View Citation

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. — View Citation

Vibert D, Häusler R, Kompis M, Vischer M. Vestibular function in patients with cochlear implantation. Acta Otolaryngol Suppl. 2001;545:29-34. — View Citation

Vibert D, Liard P, Häusler R. Bilateral idiopathic loss of peripheral vestibular function with normal hearing. Acta Otolaryngol. 1995 Sep;115(5):611-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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