Outcomes of Cochlear Implantation in Pediatrics

Hearing Impaired Children Clinical Trial

Official title:

Subjective and Functional Outcome Measures to Evaluate Performance of Pediatric Cochlear Implant

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04092231
• Other study ID #: 1815
• Status: Not yet recruiting
• Start date: May 1, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: February 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Tomblin JB et al.1997, Svirsky MA, 2004 reported that the early restoration of auditory ability by cochlear implants significantly improve the commu¬nication skills, albeit with varied results. Thoutenhoofd E 2005 concluded that while most children with cochlear implants become able to attend school regularly, other remain with significantly limited verbal communication skills

Earlier implantation for children with a congenital profound hearing loss appeared to provide improved potential for developing speech perception. which improved steadily with implant experience.

The speech perception can be defined as the process of imposing a meaningful perceptual experience from meaningless speech input, wich may be thought of involving a number of components as: detection, discrimination, identification, attention, memory and closure .

In the field of aural rehabilitation, speech perception assessment has an important and a critical role to select the signal processing strategy, to adjust the signal processor and to determine if appropriate benefit has been achived .

Young children,being considered apart of the language limited,difficult-to test population, efforts were directed towards construction of special hearing test to suit their reduced verbal language(Mc Lauchlin,1980).

The early speech test(EST) is one of these tests,which use low -verbal materials.

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.

Most studies on the impact of cochlear implants have focused on clinical assessments of efficacy (hearing and speech skills, and auditory thresholds). It is not clear how much clinical measures of efficacy (speech, hearing, and language measures) truly show the effectiveness of cochlear implants in general contexts (such as performance at home, at school, and in social settings). Vidas S et al 1992 reported that there is evidence that clinical assessment results do not correlate with performance in unstructured settings, these measures are only part for assessments of cochlear implant efficacy.

There are questionnaires that investigate the expectations of parents (Thoutenhoofd E 2005, Vaccari C, Marschark M. 1997, Spilker B, Revicki D.1996) their satisfaction level with implant, the stresses in this process8, and cochlear implant user and family quality of life .

• The Meaningful Use of Speech Scale (MUSS) questionnaire was used to analyze and measure speech skills (Nascimento et al 1997)and allows the examiner to evaluate a child skills in meaningful real world situation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 30, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

Inclusion Criteria: Between 2 and 5 years of age at time of implantation

• 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.

• All children must have completed an appropriate trial period with optimally fit amplification prior to inclusion in the study.

Exclusion Criteria:Subjects with mental retardation (MR), below average mentality or any subject with behavioral problems, traumatic brain injury, additional significant disabilities (e.g., blindness, autism) or with auditory neuropathy were excluded from the study

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Related Conditions & MeSH terms

• Deafness
• Hearing Impaired Children
• Hearing Loss

Intervention

Behavioral:
• Early speech perception test
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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Amira Mohmed Ahmed Bakr	Assiut University

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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