Clinical trial NCT04711538: Role of Diagnostic Imaging in Cochlear Implant
Official title: Role of Diagnostic Imaging in Evaluation of Cochlear Implant Candidate
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cochlear Implant
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who suffering from deep to profound sensorineural hearing loss( inculde any age,both genders)

Brief summary: cochlear implant is a well accepted treatment to profound sensorineural hearing loss. Imaging provides essential information about anatomical Variants that could be riskyand should be considered by cochlear implant surgeon and the aim of the study:-

* Identify inner ear congenital and acquired abnormalities.
* Identify cochlear nerve anomalies.
* Detect temporal bone abnormalities that require surgical modification by cochlear implant surgeon.

Detailed description: Cochlear implant (CI) is a well-accepted treatment for severe to profound sensorineural hearing loss. Patients who are refractory to conventional hearing augmentation .

(CI) is a surgically implanted device consisting of external and internal components. An external microphone and speech processor worn behind the ear and convert sound into an electrical signal. A magnet held external transmitter sends the signal via electromagnetic induction through the skin to an internal receiver- stimulator which converts the signal into rapid electrical impulses which distributed to multiple electrodes on an electrode array implanted within the cochlea. The electrodes electrically stimulate the spiral ganglion cells along the cochlear turns, which then travel along the auditory nerve axons to the brain for sound perception .

Imaging provides essential information about many of the anatomical variations that could be risky and should be considered by cochlear implant surgeon to avoid complications.

Some variations are potential surgical hazards that may lead to problems during the surgery and may alert the surgeon regarding potential surgical dangers and complications .

Both computed tomography (CT) and magnetic resonance imaging(MRI) are complementary to each other. They detect cochlear, middle ear anatomy and the anatomical variants .

The strength of CT is visualization of the bony structures of the middle and inner ear and the strength of MRI is visualization of the fluid content of the membranous labyrinth, visualization of the vestibule-cochlear nerve in the fluid filled internal auditory canal and the cerebello-pontine angle .

Eligibility criteria: Inclusion Criteria:

* Age, any age will included
* Gender, both genders will be included.
* Patient full filled criteria for CI including audiological \& phoniatric criteria

Exclusion Criteria:

* • Patient who did not fulfill the criteria for indicating CI surgery.

Primary outcomes:
measure: identification inner ear congenital and acquired abnormalities
timeFrame: immediately after end of imaging and diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
state: Sohag Governorate
Study officials:
affiliation: Sohag University
name: Mohammed H Alam-Eldeen, AP
role: STUDY_DIRECTOR
affiliation: Sohag University
name: Ramadan H Hashem, Prof
role: STUDY_CHAIR
References:
citation: Alam-Eldeen MH, Rashad UM, Ali AHA. Radiological requirements for surgical planning in cochlear implant candidates. Indian J Radiol Imaging. 2017 Jul-Sep;27(3):274-281. doi: 10.4103/ijri.IJRI_55_17.
citation: Joshi VM, Navlekar SK, Kishore GR, Reddy KJ, Kumar EC. CT and MR imaging of the inner ear and brain in children with congenital sensorineural hearing loss. Radiographics. 2012 May-Jun;32(3):683-98. doi: 10.1148/rg.323115073.
citation: Marsot-Dupuch K, Meyer B. Cochlear implant assessment: imaging issues. Eur J Radiol. 2001 Nov;40(2):119-32. doi: 10.1016/s0720-048x(01)00380-1.