Cochlear ImplantsNCT06322472
The Relationship Between Phonological Awareness Skills And Home Environment Literacy in Cochlear Implant Users
A study testing The Turkish Early Language Development Test (TEDIL), The Family Literacy Scale and The Early Childhood Phonological Sensitivity Scale (PASECP) in people with Cochlear Implants and Child Language, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
The aim was to examine the relationship between home literacy of parents whose has children who use cohlear implant and family demographic characteristics and phonological awareness skills of children with cochlear implant. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cochlear Implants, Child Language, Literacy
- What is being tested?
- The Turkish Early Language Development Test (TEDIL), The Family Literacy Scale and The Early Childhood Phonological Sensitivity Scale (PASECP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2021to 12 Feb 2022
- Phase
- Interventional
- 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 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- language skills were between 60 and 72 months; not enrolled in primary school; regular use of unilateral or bilateral cochlear implants;regular training in an auditory rehabilitation center
Who cannot join
- The study excluded individuals who did not meet the inclusion criteria for the control and study groups.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Phonological Awareness Skills and Home Environment Literacy in Cochlear Implant Users
The aim was to examine the relationship between home literacy of parents whose has children who use cohlear implant and family demographic characteristics and phonological awareness skills of children with cochlear implant.
Read the detailed description
This study was designed to determine the relationship between home literacy of parents whose has children who use cohlear implant and family demographic characteristics and phonological awareness skills of children with cochlear implant.To collect data from the parents, "Demographic Questionary" which is prepared by the researchers, "Early Literacy Home Environment Scale (ELHES)" (Karaahmetoğlu \& Turan, 2017), and "Family Literacy Scale" (Kılıç, Doğan \& Özden, 2017) were used in the study. To collect data from the children with cochlear implant users, "The Turkish Early Language Development Test (TEDİL) " (Topbaş \& Güven, 2013), and "The Early Childhood Phonological Sensitivity Scale (PASECP)" (Sarı \& Acar, 2013) were used in the study.
This study was carried out with follow-up patients in the Audiology, Language and Speech Disorders Clinic of xxx University - Medical Faculty, Department of Otorhinolaryngology. The study was performed with the approval of Ethics Committee, and written informed consent was obtained from all patient families (138955/ July 2021). There are 23 cochlear implant users and, 23 their family. Children ranging in age from 5 to 7 who also have 5-6 years old language skills without any neurological problems were included in the study.
SPSS 25.0 (IBM) was used program for statistical analysis. The differences of the numerical measurements used in the research according to the binary demographic categories were analyzed with the Mann Whitney U test, and the analysis of the differences according to the multiple categories was analyzed with the Kruskal Wallis H test. The significance level (α=0.05) was used.
- Being tested
- The Turkish Early Language Development Test (TEDIL), The Family Literacy Scale, The Early Childhood Phonological Sensitivity Scale (PASECP), The Early Literacy Home Environment Scale (ELHES), Demographic Questionaries
- Keywords
- cochlear implant, home environment, early literacy, phonological awareness, pediatri
- Medical subject headings
- Literacy, Articulation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Turkish Early Language Development Test (TEDIL)Other
The Turkish Early Language Development Test (TEDIL) is a test that measures the receptive and expressive language skills of children between the ages of 2 and 7 years and 11 months.
The Family Literacy ScaleOther
The Family Literacy Scale, which is a reliable and valid measurement scale, was developed by Kılıç, Doğan, and Özden (Kılıç, Doğan, and Özden 2017). The items of the scale consist of questions about parental literacy, child literacy, and early literacy. Parental Literacy Scale to identify and analyse situations such as the use of literacy skills, role modelling for children, performing simple literacy activities at home, on the street, etc. and generally helping children to learn to read and write.
The Early Childhood Phonological Sensitivity Scale (PASECP)Other
The Early Childhood Phonological Sensitivity Scale (PASECP), developed by Sarı and Aktan Acar (2013), measures the phonological awareness of children aged 60-72 months (Sari and Aktan Acar 2013).
The Early Literacy Home Environment Scale (ELHES)Other
The Early Literacy Home Environment Scale (ELHES) developed by Karaahmetoğlu and Turan is a reliable and valid questionnaire for assessing the early literacy home environment of families with children aged 0-6 years (Karaahmetoğlu and Turan 2020)
Demographic QuestionariesOther
The demographic survey was prepared by the researchers. The demographic survey includes questions about educational status and family's socio-economic status.
| Study group | Role | What they receive |
|---|---|---|
| 23 children with cochlear implants | Experimental | The children with cochlear implants was applied The Early Childhood Phonological Sensitivity Scale and The Turkish Early Language Development Test. Receives: Other: The Turkish Early Language Development Test (TEDIL); Other: The Early Childhood Phonological Sensitivity Scale (PASECP) |
| 23 parents | Other | Demographic Questionaries, Family Literacy Scale and ELHES were applied to the families of the participants Receives: Other: The Family Literacy Scale; Other: The Early Literacy Home Environment Scale (ELHES); Other: Demographic Questionaries |
What is being measured
The primary outcome is the main question the study is designed to answer.
The data the Early Childhood Phonological Sensitivity Scale (PASECP) from children with cochlear implants
The Early Childhood Phonological Sensitivity Scale (PASECP) which was developed by Sarı and Aktan Acar (2013) measure phonological awareness of children aged 60-72 months. The test contains eight sub-dimensions, and total of 78 items. 1 point is taken for each correct answer. The sub-dimensions of the scale are recognizing rhyme, beginning sound detection, the generating new words related to the desired phoneme, grouping words starting with the same sound within a group of words, blending phonemes, segmenting word into its syllables, omitting a word in a compound and of alphabet knowledge. The scale was used to measure the phonological awareness skills of children with cochlear implants in the study.
Measured: 3 months
The data Family Literacy Scale from parents
The Family Literacy Scale which a reliable and valid measurement scale was developed by Kılıç, Doğan, and Özden in 2017. The question items of the scale consist about parental literacy, child literacy, and early literacy. Parental Literacy Scale to identify and analyze situations such as using literacy skills, role modeling for children, performing simple literacy activities at home, on the street, etc., and generally helping children learn how to read and write. The questions were 32 items and rated on a five-point Likert scale. (Always=5 point, Often=4 points, Sometimes=3 points, Rarely=2 points, and Never=1 point). The higher scores on the scale indicate to increased parent literacy level. This scale used to determine the literacy status of families in this study.
Measured: 1 months
The data Early Literacy Home Environment Scale (ELVES) from parents
The Early Literacy Home Environment Scale (ELHES) is a scale reliable and valid questionnaire for assessing the early literacy home environments of families with children 0-6 years of age. The scale is four-point Likert. The total score is obtained by summing all the items (the lowest score is 8, and the highest score is 32). The scale of home early literacy environment range from 8 to 32; 8-15 is "insufficient", 16-23 "medium", 24-32 "sufficient". It was used to evaluate the early literacy opportunities provided by families for children with using cochlear implants in the home environment.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start10 Jan 2021
- Primary completion24 May 2021
- Study completion12 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Cochlear ImplantsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Descriptive research
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Büşra AKSU, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322472
- Sponsor's protocol ID
- 138956
- Status last verified
- Mar 2024
- First submitted
- 19 Feb 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ching TY, Cupples L. Phonological Awareness at 5 years of age in Children who use Hearing Aids or Cochlear Implants. Perspect Hear Hear Disord Child. 2015 Sep;25(2):48-59. doi: 10.1044/hhdc25.2.48.
PubMed 26929789Ahmed, Eman, Ahmed Elmesalamy, Fekry Mohamed, Hassan El-Ater, Mohamed Fekry, and El-Ater Hassan. 2022. "The Role of the Home Literacy Environment and Parent Education in Effecting the Developmental Differences of Phonological Awareness During Early Child Hood." American Journal of Applied Psychology 11 (1): 36.
Bell, Nicola, Anthony J. Angwin, Wayne J. Wilson, and Wendy L. Arnott. 2022. "Literacy Development in Children with Cochlear Implants: A Narrative Review." Australian Journal of Learning Difficulties 27 (1): 115-34.
Ebert S, Lehrl S, Weinert S. Differential Effects of the Home Language and Literacy Environment on Child Language and Theory of Mind and Their Relation to Socioeconomic Background. Front Psychol. 2020 Oct 29;11:555654. doi: 10.3389/fpsyg.2020.555654. eCollection 2020.
PubMed 33192809DesJardin JL, Ambrose SE, Eisenberg LS. Literacy skills in children with cochlear implants: the importance of early oral language and joint storybook reading. J Deaf Stud Deaf Educ. 2009 Winter;14(1):22-43. doi: 10.1093/deafed/enn011. Epub 2008 Apr 15.
PubMed 18417463Eyalati N, Jafari Z, Ashayeri H, Salehi M, Kamali M. Effects of parental education level and economic status on the needs of families of hearing-impaired children in the aural rehabilitation program. Iran J Otorhinolaryngol. 2013 Winter;25(70):41-8.
PubMed 24303418Hassunah-Arafat, Safieh Muhamad, Dorit Aram, and Ofra Korat. 2021. "Early Literacy in Arabic: The Role of SES, Home Literacy Environment, Mothers' Early Literacy Beliefs and Estimation of Their Children's Literacy Skills." Reading and Writing 34 (10): 2603-25.
Incognito, Oriana, and Giuliana Pinto. 2021. "Longitudinal Effects of Family and School Context on the Development on Emergent Literacy Skills in Preschoolers." Current Psychology.
Ingvalson EM, Grieco-Calub TM, Perry LK, VanDam M. Rethinking Emergent Literacy in Children With Hearing Loss. Front Psychol. 2020 Jan 31;11:39. doi: 10.3389/fpsyg.2020.00039. eCollection 2020.
PubMed 32082217Kim, Sojung, Haesung Im, and Kyong Ah Kwon. 2015. "The Role of Home Literacy Environment in Toddlerhood in Development of Vocabulary and Decoding Skills." Child and Youth Care Forum 44 (6): 835-52.
Liu, Cuina, George K. Georgiou, and George Manolitsis. 2018. "Modeling the Relationships of Parents' Expectations, Family's SES, and Home Literacy Environment with Emergent Literacy Skills and Word Reading in Chinese." Early Childhood Research Quarterly 43: 1-10.
Luo, Rufan, Amy Pace, Dani Levine, Aquiles Iglesias, Jill de Villiers, Roberta Michnick Golinkoff, Mary Sweig Wilson, and Kathy Hirsh-Pasek. 2021. "Home Literacy Environment and Existing Knowledge Mediate the Link between Socioeconomic Status and Language Learning Skills in Dual Language Learners." Early Childhood Research Quarterly 55: 1-14.
Ngorosho, Damaris, and Ulla Lahtinen. 2010. "The Role of the Home Environment in Phonological Awareness and Reading and Writing Ability in Tanzanian Primary Schoolchildren." Education Inquiry 1 (3): 211-34.
Pluijm, M Van Der, A Van Gelderen, and J Kessels. 2019. "Activities and Strategies for Parents With Less Education to Promote the Oral Language Development of Their Children: A Review of Empirical Interventions." School Community Journal 29 (1): 317-62.
Riser, Quentin H., Heather L. Rouse, Ji Young Choi, and Seulki Ku. 2020. "The Contribution of Home Literacy Context to Preschool Academic Competencies for American Indian and Alaska Native Children." Child and Youth Care Forum 49 (2): 303-23. https://doi.org/10.1007/s10566-019-09529-1.
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Phonological Awareness Skills and Home Environment Literacy in Cochlear Implant Users
- ClinicalTrials.gov ID
- NCT06322472
- Acronym / sponsor ID
- 138956
- Keywords
- cochlear implant, home environment, early literacy, phonological awareness, pediatri
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 24 May 2021 (actual)
- Study completion
- 12 Feb 2022 (actual)
- First posted
- 21 Mar 2024 (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 aim was to examine the relationship between home literacy of parents whose has children who use cohlear implant and family demographic characteristics and phonological awareness skills of children with cochlear implant.
Detailed description
This study was designed to determine the relationship between home literacy of parents whose has children who use cohlear implant and family demographic characteristics and phonological awareness skills of children with cochlear implant.To collect data from the parents, "Demographic Questionary" which is prepared by the researchers, "Early Literacy Home Environment Scale (ELHES)" (Karaahmetoğlu \& Turan, 2017), and "Family Literacy Scale" (Kılıç, Doğan \& Özden, 2017) were used in the study. To collect data from the children with cochlear implant users, "The Turkish Early Language Development Test (TEDİL) " (Topbaş \& Güven, 2013), and "The Early Childhood Phonological Sensitivity Scale (PASECP)" (Sarı \& Acar, 2013) were used in the study.
This study was carried out with follow-up patients in the Audiology, Language and Speech Disorders Clinic of xxx University - Medical Faculty, Department of Otorhinolaryngology. The study was performed with the approval of Ethics Committee, and written informed consent was obtained from all patient families (138955/ July 2021). There are 23 cochlear implant users and, 23 their family. Children ranging in age from 5 to 7 who also have 5-6 years old language skills without any neurological problems were included in the study.
SPSS 25.0 (IBM) was used program for statistical analysis. The differences of the numerical measurements used in the research according to the binary demographic categories were analyzed with the Mann Whitney U test, and the analysis of the differences according to the multiple categories was analyzed with the Kruskal Wallis H test. The significance level (α=0.05) was used.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Descriptive research
| Arm | Type | Receives |
|---|---|---|
| 23 children with cochlear implants | Experimental | Other: The Turkish Early Language Development Test (TEDIL), Other: The Early Childhood Phonological Sensitivity Scale (PASECP)The children with cochlear implants was applied The Early Childhood Phonological Sensitivity Scale and The Turkish Early Language Development Test. |
| 23 parents | Other | Other: The Family Literacy Scale, Other: The Early Literacy Home Environment Scale (ELHES), Other: Demographic QuestionariesDemographic Questionaries, Family Literacy Scale and ELHES were applied to the families of the participants |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- language skills were between 60 and 72 months; not enrolled in primary school; regular use of unilateral or bilateral cochlear implants;regular training in an auditory rehabilitation center
Key exclusion criteria (1 listed)
- The study excluded individuals who did not meet the inclusion criteria for the control and study groups.
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 |
|---|---|---|
| The Turkish Early Language Development Test (TEDIL)The Turkish Early Language Development Test (TEDIL) is a test that measures the receptive and expressive language skills of children between the ages of 2 and 7 years and 11 months. | Other | 23 children with cochlear implants |
| The Family Literacy ScaleThe Family Literacy Scale, which is a reliable and valid measurement scale, was developed by Kılıç, Doğan, and Özden (Kılıç, Doğan, and Özden 2017). The items of the scale consist of questions about parental literacy, child literacy, and early literacy. Parental Literacy Scale to identify and analyse situations such as the use of literacy skills, role modelling for children, performing simple literacy activities at home, on the street, etc. and generally helping children to learn to read and write. | Other | 23 parents |
| The Early Childhood Phonological Sensitivity Scale (PASECP)The Early Childhood Phonological Sensitivity Scale (PASECP), developed by Sarı and Aktan Acar (2013), measures the phonological awareness of children aged 60-72 months (Sari and Aktan Acar 2013). | Other | 23 children with cochlear implants |
| The Early Literacy Home Environment Scale (ELHES)The Early Literacy Home Environment Scale (ELHES) developed by Karaahmetoğlu and Turan is a reliable and valid questionnaire for assessing the early literacy home environment of families with children aged 0-6 years (Karaahmetoğlu and Turan 2020) | Other | 23 parents |
| Demographic QuestionariesThe demographic survey was prepared by the researchers. The demographic survey includes questions about educational status and family's socio-economic status. | Other | 23 parents |
Primary outcome
The data the Early Childhood Phonological Sensitivity Scale (PASECP) from children with cochlear implants
Time frame: 3 months
The Early Childhood Phonological Sensitivity Scale (PASECP) which was developed by Sarı and Aktan Acar (2013) measure phonological awareness of children aged 60-72 months. The test contains eight sub-dimensions, and total of 78 items. 1 point is taken for each correct answer. The sub-dimensions of the scale are recognizing rhyme, beginning sound detection, the generating new words related to the desired phoneme, grouping words starting with the same sound within a group of words, blending phonemes, segmenting word into its syllables, omitting a word in a compound and of alphabet knowledge. The scale was used to measure the phonological awareness skills of children with cochlear implants in the study.
The data Family Literacy Scale from parents
Time frame: 1 months
The Family Literacy Scale which a reliable and valid measurement scale was developed by Kılıç, Doğan, and Özden in 2017. The question items of the scale consist about parental literacy, child literacy, and early literacy. Parental Literacy Scale to identify and analyze situations such as using literacy skills, role modeling for children, performing simple literacy activities at home, on the street, etc., and generally helping children learn how to read and write. The questions were 32 items and rated on a five-point Likert scale. (Always=5 point, Often=4 points, Sometimes=3 points, Rarely=2 points, and Never=1 point). The higher scores on the scale indicate to increased parent literacy level. This scale used to determine the literacy status of families in this study.
The data Early Literacy Home Environment Scale (ELVES) from parents
Time frame: 2 weeks
The Early Literacy Home Environment Scale (ELHES) is a scale reliable and valid questionnaire for assessing the early literacy home environments of families with children 0-6 years of age. The scale is four-point Likert. The total score is obtained by summing all the items (the lowest score is 8, and the highest score is 32). The scale of home early literacy environment range from 8 to 32; 8-15 is "insufficient", 16-23 "medium", 24-32 "sufficient". It was used to evaluate the early literacy opportunities provided by families for children with using cochlear implants in the home environment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Background: PubMed 26929789Ching TY, Cupples L. Phonological Awareness at 5 years of age in Children who use Hearing Aids or Cochlear Implants. Perspect Hear Hear Disord Child. 2015 Sep;25(2):48-59. doi: 10.1044/hhdc25.2.48.
- BackgroundAhmed, Eman, Ahmed Elmesalamy, Fekry Mohamed, Hassan El-Ater, Mohamed Fekry, and El-Ater Hassan. 2022. "The Role of the Home Literacy Environment and Parent Education in Effecting the Developmental Differences of Phonological Awareness During Early Child Hood." American Journal of Applied Psychology 11 (1): 36.
- BackgroundBell, Nicola, Anthony J. Angwin, Wayne J. Wilson, and Wendy L. Arnott. 2022. "Literacy Development in Children with Cochlear Implants: A Narrative Review." Australian Journal of Learning Difficulties 27 (1): 115-34.
- Background: PubMed 33192809Ebert S, Lehrl S, Weinert S. Differential Effects of the Home Language and Literacy Environment on Child Language and Theory of Mind and Their Relation to Socioeconomic Background. Front Psychol. 2020 Oct 29;11:555654. doi: 10.3389/fpsyg.2020.555654. eCollection 2020.
- Background: PubMed 18417463DesJardin JL, Ambrose SE, Eisenberg LS. Literacy skills in children with cochlear implants: the importance of early oral language and joint storybook reading. J Deaf Stud Deaf Educ. 2009 Winter;14(1):22-43. doi: 10.1093/deafed/enn011. Epub 2008 Apr 15.
- Background: PubMed 24303418Eyalati N, Jafari Z, Ashayeri H, Salehi M, Kamali M. Effects of parental education level and economic status on the needs of families of hearing-impaired children in the aural rehabilitation program. Iran J Otorhinolaryngol. 2013 Winter;25(70):41-8.
- BackgroundHassunah-Arafat, Safieh Muhamad, Dorit Aram, and Ofra Korat. 2021. "Early Literacy in Arabic: The Role of SES, Home Literacy Environment, Mothers' Early Literacy Beliefs and Estimation of Their Children's Literacy Skills." Reading and Writing 34 (10): 2603-25.
- BackgroundIncognito, Oriana, and Giuliana Pinto. 2021. "Longitudinal Effects of Family and School Context on the Development on Emergent Literacy Skills in Preschoolers." Current Psychology.
- Background: PubMed 32082217Ingvalson EM, Grieco-Calub TM, Perry LK, VanDam M. Rethinking Emergent Literacy in Children With Hearing Loss. Front Psychol. 2020 Jan 31;11:39. doi: 10.3389/fpsyg.2020.00039. eCollection 2020.
- BackgroundKim, Sojung, Haesung Im, and Kyong Ah Kwon. 2015. "The Role of Home Literacy Environment in Toddlerhood in Development of Vocabulary and Decoding Skills." Child and Youth Care Forum 44 (6): 835-52.
- BackgroundLiu, Cuina, George K. Georgiou, and George Manolitsis. 2018. "Modeling the Relationships of Parents' Expectations, Family's SES, and Home Literacy Environment with Emergent Literacy Skills and Word Reading in Chinese." Early Childhood Research Quarterly 43: 1-10.
- BackgroundLuo, Rufan, Amy Pace, Dani Levine, Aquiles Iglesias, Jill de Villiers, Roberta Michnick Golinkoff, Mary Sweig Wilson, and Kathy Hirsh-Pasek. 2021. "Home Literacy Environment and Existing Knowledge Mediate the Link between Socioeconomic Status and Language Learning Skills in Dual Language Learners." Early Childhood Research Quarterly 55: 1-14.
- Individual participant dataSharing planned: No
Related trials for Cochlear Implants
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
Cochlear Hearing Loss
RecruitingObservational study
Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.
Cochlear Implantation, Sensorineural Hearing Loss
Recruiting
Cochlear Implants and Listening Effort: the Interaction of Cognitive and Sensory Constraints
Cochlear Implant Users
Recruiting
Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
Deafness
Not yet recruitingObservational study
Mi2000 TICI Follow-up
Hearing Loss, Binaural, Cochlear Implantation
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Turkish Early Language Development Test (TEDIL), The Family Literacy Scale and The Early Childhood Phonological Sensitivity Scale (PASECP) in people with Cochlear Implants and Child Language, run by Uskudar University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: finished, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The data the Early Childhood Phonological Sensitivity Scale (PASECP) from children with cochlear implants (time frame: 3 months). The study lists 3 primary outcomes in all. 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 NCT06322472, which also lists 22 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 21 Mar 2024.