Outcomes of Cochlear Implantation in Pediatrics

NCT04092231 | Unknown

• 1 other identifier: 1815
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The cochlear implant (CI) is the most important progress in the treatment for adults and children with severe to profound bilateral sensorineural hearing loss who do not receive adequa¬te benefit from hearing aids and making possible better results in auditory, linguistic, social and academic development.

Conditions

Hearing Impaired Children

Keywords

Hearing loss

Outcome Measures

Primary Outcomes (1)

• change in percent correct in speech perception as measured with single words presented in a closed set

  ):-Change in percent correct in speech perception as measured with single words presented in a closed set. \[ Time Frame: Speech perception will be compared baseline to 3 month post implant, baseline to 6 month post implant, baseline to 9 month post implant, baseline to 12 months post implant, baseline to 18 months post implant and baseline to 24 months post implant Closed set word identification presented by direct input to the speech processor using the Early Speech Perception (ESP)Test (Moog \& Geers,1990), which is a test commonly used to assess young children with hearing loss 2-patient related benefits - improvements in hearing ability assessed via Meaningful Auditory Integration Scale.

  1 year

Study Arms (1)

1

Thirty children were between two and five years of age at the time of implantation. All were congenital pre-linguistically bilateral profound sensorineural hearing loss. Reports about basic audiological evaluation which included air and bone conduction thresholds, speech audiometry for all the study group before the implantation were obtained. They had limited benefit from consistent use of hearing aid amplification and enrolled in a rehabilitation program focused on oral communication. they underwent unilateral CI with CI experience ranged from 6 months and above.

Behavioral: Early speech perception test

Interventions

Early speech perception test BEHAVIORAL

The early speech test is one of the closed-set response speech discrimination tests,using object identification technique.It was carefully designed for estimation of speech perception abilities in very young children who have extremely low verbal abilities

Also known as: Meaningful Auditory Integration Scale

1

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Thirty children were between two and five years of age at the time of implantation. All were congenital pre-linguistically bilateral profound sensorineural hearing loss. Reports about basic audiological evaluation which included air and bone conduction thresholds, speech audiometry for all the study group before the implantation were obtained. They had limited benefit from consistent use of hearing aid amplification and enrolled in a rehabilitation program focused on oral communication. they underwent unilateral CI with CI experience ranged from 6 months and above.

You may qualify if:

• Profound bilateral sensorineural hearing loss
• Arabic as the primary language in the home
• Realistic expectations of guardians
• Child must be enrolled in a post-operative rehabilitative/educational program that supports the use of cochlear implants and the development of auditory-based skills
• Willing and available to comply with all scheduled procedures as defined in the protocol
• Profound bilateral sensorineural hearing loss with average thresholds between ears of 90 dB HL or greater at 1000 Hz and aboveBehavioral test measures must include unaided threshold measures for the right and left ears using insert earphones; left-alone and right-alone aided sound field threshold measurements; and aided and unaided speech-awareness / detection thresholds (for each ear individually)
• Children accepted into the study must be able to demonstrate a consistent response to sound. If a child has no measurable hearing, he/she must be able to demonstrate a consistent response to vibrotactile stimuli.

Sponsors & Collaborators

• Amira Mohmed Ahmed Bakr: lead
• Assiut University: collaborator

Related Publications (3)

• Cavicchiolo S, Mozzanica F, Guerzoni L, Murri A, Dall'Ora I, Ambrogi F, Barozzi S, Cuda D, Schindler A. Early prelingual auditory development in Italian infants and toddlers analysed through the Italian version of the Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS). Eur Arch Otorhinolaryngol. 2018 Feb;275(2):615-622. doi: 10.1007/s00405-017-4847-6. Epub 2017 Dec 16.

  PMID: 29248951 BACKGROUND

• Nilakantan A, Raj P, Saini S, Mittal R. Early Speech Perception Test Outcome in Children with Severe Sensorineural Hearing Loss with Unilateral Cochlear Implants Alone versus Bimodal Stimulation. Indian J Otolaryngol Head Neck Surg. 2018 Sep;70(3):398-404. doi: 10.1007/s12070-018-1398-0. Epub 2018 May 14.

  PMID: 30211097 BACKGROUND

• Thomas E, El-Kashlan H, Zwolan TA. Children with cochlear implants who live in monolingual and bilingual homes. Otol Neurotol. 2008 Feb;29(2):230-4. doi: 10.1097/mao.0b013e31815f668b.

  PMID: 18223450 BACKGROUND

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: September 14, 2019
• First Posted: September 17, 2019
• Study Start: May 1, 2020
• Primary Completion: October 1, 2022
• Study Completion: December 30, 2022
• Last Updated: February 25, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share