Hearing Impaired ChildrenNCT04092231
Outcomes of Cochlear Implantation in Pediatrics
An observational study of Hearing Impaired Children, run by Amira Mohmed Ahmed Bakr.
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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Hearing Impaired Children
- What is being tested?
- Early speech perception test
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2020to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
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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About this study
Official title: Subjective and Functional Outcome Measures to Evaluate Performance of Pediatric Cochlear Implant
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.
Read the detailed 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.
- Conditions
- Hearing Impaired Children
- Being tested
- Early speech perception test
- Keywords
- Hearing loss
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early speech perception testBehavioural
Also called Meaningful Auditory Integration Scale
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Early speech perception test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start1 May 2020 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hearing Impaired ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amira Mohmed Ahmed Bakr
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Sponsor-investigator, Amira Mohmed Ahmed Bakr, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092231
- Sponsor's protocol ID
- 1815
- Status last verified
- Feb 2020
- First submitted
- 14 Sep 2019
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29248951Nilakantan 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.
PubMed 30211097Thomas 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.
PubMed 18223450
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subjective and Functional Outcome Measures to Evaluate Performance of Pediatric Cochlear Implant
- ClinicalTrials.gov ID
- NCT04092231
- Acronym / sponsor ID
- 1815
- Conditions
- Hearing Impaired Children
- Keywords
- Hearing loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Amira Mohmed Ahmed BakrUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 17 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: Early speech perception testThirty 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. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early speech perception testAlso: Meaningful Auditory Integration ScaleThe 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 | Behavioural | 1 |
Primary outcome
change in percent correct in speech perception as measured with single words presented in a closed set
Time frame: 1 year
):-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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Background: PubMed 29248951Cavicchiolo 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.
- Background: PubMed 30211097Nilakantan 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.
- Background: PubMed 18223450Thomas 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Impaired Children, run by Amira Mohmed Ahmed Bakr.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in percent correct in speech perception as measured with single words presented in a closed set (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04092231, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.