TelerehabilitationNCT05543031
Effect Of Music Integrated Phonological Awareness Program On Preschool Cochlear Implant Users
A study testing Music-Integrated Phonological Awareness training program, Spectral-Temporally Modulated Ripple Test (SMRT) and The Phonological Awareness Scale of Early Childhood Period (PASECP) in people with Telerehabilitation, run by Uskudar University at 2 sites in Turkey (Türkiye).
Trial summary
The aim was to observe the effect of the music integrated phonological awareness program on preschool cochlear implant users and to compare the phonological awareness skills of the study group with the control group before and after the online training. Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Telerehabilitation
- What is being tested?
- Music-Integrated Phonological Awareness training program, Spectral-Temporally Modulated Ripple Test (SMRT) and The Phonological Awareness Scale of Early Childhood Period (PASECP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 18 Mar 2021to 16 Jul 2021
- 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 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- For children with hearing loss
- Bilateral severe sensorineural hearing loss
- Having unilateral or bilateral cochlear implants,
- Having a chronological age in the range of 5-7 years,
- Not having started primary school.
- Using the cochlear implant and regularly
Show all 11Show fewer
- To receive regular training in the auditory rehabilitation center
- For children with normal hearing:
- To have normal hearing,
- To have receptive and expressive language skills compatible with the chronological age in the language test to be performed.
- Not starting primary school
Who cannot join
- In case of not having any without being accepted for control and study,
- Having additional disability
- Using drugs affecting the auditory system
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istanbul University-Cerrahpasa
Istanbul, 34098
Uskudar University
Istanbul
About this study
The aim was to observe the effect of the music integrated phonological awareness program on preschool cochlear implant users and to compare the phonological awareness skills of the study group with the control group before and after the online training.
Read the detailed description
This study was designed to determine the benefit of music integrated phonological awareness programs for children using cochlear implants. In addition, the phonological skills and language skills of children using cochlear implants and children with normal hearing were compared in the pre and post-training results. Test of Early Language Development (TELD-3), The Phonological Awareness Scale of Early Childhood Period (PASECP), Mismatch Negativity (MMN) was used in this 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 9 female and 14 male cochlear implant users in the study group; 9 female and 14 male children with normal hearing in the control group. 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. Cochlear implant mappings of all children were checked before the training.
SPSS 25.0 (IBM) was used for statistical analysis. Pre and post-training comparisons of The Phonological Awareness Scale of Early Childhood Period, SMRT, and Mismatch Negativity tests were analyzed with the Wilcoxon test. The correlation of numerical measurements with each other was examined with Spearman Correlation. The differences in the numerical measurements used in the research according to the binary demographic categories were analyzed with the Mann-Whitney U test. The differences according to the multiple categories were analyzed using the Kruskal Wallis H test. The significance level (α=0,05) was used.
- Conditions
- Telerehabilitation
- Being tested
- Music-Integrated Phonological Awareness training program, Spectral-Temporally Modulated Ripple Test (SMRT), The Phonological Awareness Scale of Early Childhood Period (PASECP), Mismatch Negativity Test, Early Language Development (TELD-3)
- Keywords
- Phonological awareness training, music, cochlear implant, telerehabilitation, mismatch negativity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music-Integrated Phonological Awareness training programOther
We would like to observe the effect of the music integrated phonological awareness program on preschool cochlear implant users and to compare the phonological awareness skills of the study group with the control group before and after the online training. The program is prepared as 10 lessons. Participants were guided through online training for 5 weeks, with 20-minute sessions conducted weekly. The training was carried out via Zoom, a free virtual interview program. Each family had a computer.
Spectral-Temporally Modulated Ripple Test (SMRT)Diagnostic test
Spectral-Temporally Modulated Ripple Test (SMRT) was used to assess the spectral discrimination ability of the study group.Speech stimuli were presented at a calibrated presentation level of 60 dB SPL in a quiet room. The child was positioned at 0° azimuth and 1-meter from the loudspeaker.
The Phonological Awareness Scale of Early Childhood Period (PASECP)Diagnostic test
The Phonological Awareness Scale of Early Childhood Period (PASECP) was used to measure the sound awareness and sound discrimination skills of study group pre-post training. The test has 8 sub-dimensions.
Mismatch Negativity TestDiagnostic test
Mismatch Negativity (MMN) was used to evaluate the central auditory system.The test was used for electrophysiological recordings of the study group.The standard stimulus presented as /ba/ (%80), and the rare stimulus presented as /da/ (%20) frequency. The onset (rise) and offset (fall) times of the stimuli are 10 ms, and the plateau time is 50 ms. The interval between stimuli for both responses was 1.1 ms. A 0.1-30 Hz filter was applied. The speech stimuli intensity was 70 dB SPL. Speech stimuli were presented at a 1-meter distance from the participant, with speakers placed at an angle of 0°.
Early Language Development (TELD-3)Diagnostic test
Test of Early Language Development (TELD-3) measured children's receptive and expressive language skills both group for inclusion criteria.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | There are 9 (35,8%) female and 14 (64,2%) male preschool cochlear implant users in the study group.
Children ranging in age from 5 to 7 who also have 5-6 years old language skills. Receives: Other: Music-Integrated Phonological Awareness training program; Diagnostic Test: Spectral-Temporally Modulated Ripple Test (SMRT); Diagnostic Test: The Phonological Awareness Scale of Early Childhood Period (PASECP); Diagnostic Test: Mismatch Negativity Test; Diagnostic Test: Early Language Development (TELD-3) |
| Control group | Experimental | There are 9 (35.8%) female and 14 (64,2%) male preschool children with normal hearing in the control group.
Children ranging in age from 5 to 6 who also have age-appropriate language skills. Receives: Diagnostic Test: The Phonological Awareness Scale of Early Childhood Period (PASECP); Diagnostic Test: Early Language Development (TELD-3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the phonological awareness skills at 3 Months
The Early Childhood Phonological Awareness Scale (PASECP) was used to measure sound awareness and sound discrimination skills of preschool children whose language age is between 60-72 months. The test has 8 sub-dimensions. There are 8 test items in the first sub-dimension and 10 test items in the other sub-dimensions, with a total of 78 test items. If the answers given by the children to the scale items are correct (1), if incorrect (0), they are coded into the answer key. The test is administered to children individually. The application time for each child takes approximately 15 minutes. High scores of the child indicate that his/her phonological awareness is good.
Measured: baseline and 3 months
Change from Electrophysiological at 3 Months
Mismatch Negativity (MMN) was used to evaluate the central auditory system. Neuron-Spectrum-5 (4/EPM) (Neurosoft, Ivanoco, Russia) was used for the electrophysiological recordings of the study group. Speech stimuli were used as stimuli. Amplitude and latency changes were observed in the Mismatch Negativity test before and after the training. The increase in amplitudes and shortening of latencies after training indicate that the central auditory system has developed.
Measured: baseline and 3 months
Change from baseline in the spectral discrimination ability at 3 Months
Spectral-Temporally Modulated Ripple Test (SMRT) was used to assess the spectral discrimination ability of the study group. The test was performed using SMRT software. Waveform broadband noise with spectral-temporal modulation was used. In each trial, three ripple sounds were presented. Two stimuli were reference signals with an intensity of 20 ripple/octave (rpo) and another stimulus was a target signal with a lower rpo intensity. The initial intensity of the target signal was 0.5 rpo and was replaced by a step size of 0.2 rpo. Adaptive running terminated after ten reverses.Spectral-Temporally Modulated Ripple Test was calculated over the last six reversals. Three runs were completed for each child, and the final threshold was determined by averaging the three runs. Having a low rpo value was an indication of good spectral resolution of the children.
Measured: baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start18 Mar 2021
- Primary completion2 Jun 2021
- Study completion16 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for TelerehabilitationStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study was designed to determine the benefit of music integrated phonological awareness programs for children using cochlear implants. In addition, the phonological skills and language skills of children using cochlear implants and children with normal hearing were compared in the pre and post-training results.
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Büşra Yılanlı, Uskudar University
- Investigators
- Büşra Yılanlı, Msc, Principal investigator, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543031
- Sponsor's protocol ID
- 138955
- Status last verified
- Sep 2022
- First submitted
- 26 Aug 2022
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD available upon reasonable request to the other authors
Publications
Carroll JM, Snowling MJ, Hulme C, Stevenson J. The development of phonological awareness in preschool children. Dev Psychol. 2003 Sep;39(5):913-23. doi: 10.1037/0012-1649.39.5.913.
PubMed 12952403Ching 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 26929789Ching TY, Dillon H, Katsch R, Byrne D. Maximizing effective audibility in hearing aid fitting. Ear Hear. 2001 Jun;22(3):212-24. doi: 10.1097/00003446-200106000-00005.
PubMed 11409857Soleymani Z, Mahmoodabadi N, Nouri MM. Language skills and phonological awareness in children with cochlear implants and normal hearing. Int J Pediatr Otorhinolaryngol. 2016 Apr;83:16-21. doi: 10.1016/j.ijporl.2016.01.013. Epub 2016 Jan 25.
PubMed 26968046Christiner M, Reiterer SM. Early Influence of Musical Abilities and Working Memory on Speech Imitation Abilities: Study with Pre-School Children. Brain Sci. 2018 Sep 1;8(9):169. doi: 10.3390/brainsci8090169.
PubMed 30200479Anvari SH, Trainor LJ, Woodside J, Levy BA. Relations among musical skills, phonological processing, and early reading ability in preschool children. J Exp Child Psychol. 2002 Oct;83(2):111-30. doi: 10.1016/s0022-0965(02)00124-8.
PubMed 12408958Choi JE, Won JH, Kim CH, Cho YS, Hong SH, Moon IJ. Relationship between spectrotemporal modulation detection and music perception in normal-hearing, hearing-impaired, and cochlear implant listeners. Sci Rep. 2018 Jan 15;8(1):800. doi: 10.1038/s41598-017-17350-w.
PubMed 29335454Engstrom E, Kallioinen P, Nakeva von Mentzer C, Lindgren M, Sahlen B, Lyxell B, Ors M, Uhlen I. Auditory event-related potentials and mismatch negativity in children with hearing loss using hearing aids or cochlear implants - A three-year follow-up study. Int J Pediatr Otorhinolaryngol. 2021 Jan;140:110519. doi: 10.1016/j.ijporl.2020.110519. Epub 2020 Nov 24.
PubMed 33268013DiNino M, Arenberg JG. Age-Related Performance on Vowel Identification and the Spectral-temporally Modulated Ripple Test in Children With Normal Hearing and With Cochlear Implants. Trends Hear. 2018 Jan-Dec;22:2331216518770959. doi: 10.1177/2331216518770959.
PubMed 29708065Fernandes NM, Gil D, Azevedo MF. Mismatch Negativity in Children with Cochlear Implant. Int Arch Otorhinolaryngol. 2019 Jul;23(3):e292-e298. doi: 10.1055/s-0039-1688967. Epub 2019 May 28.
PubMed 31360248Ferreira DA, Bueno CD, de Costa SS, Sleifer P. Mismatch Negativity in Children: Reference Values. Int Arch Otorhinolaryngol. 2019 Apr;23(2):142-146. doi: 10.1055/s-0038-1667313. Epub 2018 Oct 24.
PubMed 30956696Gifford RH, Noble JH, Camarata SM, Sunderhaus LW, Dwyer RT, Dawant BM, Dietrich MS, Labadie RF. The Relationship Between Spectral Modulation Detection and Speech Recognition: Adult Versus Pediatric Cochlear Implant Recipients. Trends Hear. 2018 Jan-Dec;22:2331216518771176. doi: 10.1177/2331216518771176.
PubMed 29716437Jeddi Z, Lotfi Y, Moossavi A, Bakhshi E, Hashemi SB. Correlation between Auditory Spectral Resolution and Speech Perception in Children with Cochlear Implants. Iran J Med Sci. 2019 Sep;44(5):382-389. doi: 10.30476/IJMS.2019.44967.
PubMed 31582862Jing L, Vermeire K, Mangino A, Reuterskiold C. Rhyme Awareness in Children With Normal Hearing and Children With Cochlear Implants: An Exploratory Study. Front Psychol. 2019 Sep 12;10:2072. doi: 10.3389/fpsyg.2019.02072. eCollection 2019.
PubMed 31572265Kraus N, Hornickel J, Strait DL, Slater J, Thompson E. Engagement in community music classes sparks neuroplasticity and language development in children from disadvantaged backgrounds. Front Psychol. 2014 Dec 16;5:1403. doi: 10.3389/fpsyg.2014.01403. eCollection 2014.
PubMed 25566109
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Music Integrated Phonological Awareness Program On Preschool Cochlear Implant Users
- ClinicalTrials.gov ID
- NCT05543031
- Acronym / sponsor ID
- 138955
- Conditions
- Telerehabilitation
- Keywords
- Phonological awareness training, music, cochlear implant, telerehabilitation, mismatch negativity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 2 Jun 2021 (actual)
- Study completion
- 16 Jul 2021 (actual)
- First posted
- 16 Sep 2022 (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 observe the effect of the music integrated phonological awareness program on preschool cochlear implant users and to compare the phonological awareness skills of the study group with the control group before and after the online training.
Detailed description
This study was designed to determine the benefit of music integrated phonological awareness programs for children using cochlear implants. In addition, the phonological skills and language skills of children using cochlear implants and children with normal hearing were compared in the pre and post-training results. Test of Early Language Development (TELD-3), The Phonological Awareness Scale of Early Childhood Period (PASECP), Mismatch Negativity (MMN) was used in this 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 9 female and 14 male cochlear implant users in the study group; 9 female and 14 male children with normal hearing in the control group. 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. Cochlear implant mappings of all children were checked before the training.
SPSS 25.0 (IBM) was used for statistical analysis. Pre and post-training comparisons of The Phonological Awareness Scale of Early Childhood Period, SMRT, and Mismatch Negativity tests were analyzed with the Wilcoxon test. The correlation of numerical measurements with each other was examined with Spearman Correlation. The differences in the numerical measurements used in the research according to the binary demographic categories were analyzed with the Mann-Whitney U test. The differences according to the multiple categories were analyzed using the Kruskal Wallis H test. The significance level (α=0,05) was used.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study was designed to determine the benefit of music integrated phonological awareness programs for children using cochlear implants. In addition, the phonological skills and language skills of children using cochlear implants and children with normal hearing were compared in the pre and post-training results.
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Music-Integrated Phonological Awareness training program, Diagnostic Test: Spectral-Temporally Modulated Ripple Test (SMRT), Diagnostic Test: The Phonological Awareness Scale of Early Childhood Period (PASECP), Diagnostic Test: Mismatch Negativity Test, Diagnostic Test: Early Language Development (TELD-3)There are 9 (35,8%) female and 14 (64,2%) male preschool cochlear implant users in the study group. Children ranging in age from 5 to 7 who also have 5-6 years old language skills. |
| Control group | Experimental | Diagnostic Test: The Phonological Awareness Scale of Early Childhood Period (PASECP), Diagnostic Test: Early Language Development (TELD-3)There are 9 (35.8%) female and 14 (64,2%) male preschool children with normal hearing in the control group. Children ranging in age from 5 to 6 who also have age-appropriate language skills. |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- For children with hearing loss
- Bilateral severe sensorineural hearing loss
- Having unilateral or bilateral cochlear implants,
- Having a chronological age in the range of 5-7 years,
- Not having started primary school.
Key exclusion criteria (3 listed)
- In case of not having any without being accepted for control and study,
- Having additional disability
- Using drugs affecting the auditory system
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 |
|---|---|---|
| Music-Integrated Phonological Awareness training programWe would like to observe the effect of the music integrated phonological awareness program on preschool cochlear implant users and to compare the phonological awareness skills of the study group with the control group before and after the online training. The program is prepared as 10 lessons. Participants were guided through online training for 5 weeks, with 20-minute sessions conducted weekly. The training was carried out via Zoom, a free virtual interview program. Each family had a computer. | Other | Study group |
| Spectral-Temporally Modulated Ripple Test (SMRT)Spectral-Temporally Modulated Ripple Test (SMRT) was used to assess the spectral discrimination ability of the study group.Speech stimuli were presented at a calibrated presentation level of 60 dB SPL in a quiet room. The child was positioned at 0° azimuth and 1-meter from the loudspeaker. | Diagnostic test | Study group |
| The Phonological Awareness Scale of Early Childhood Period (PASECP)The Phonological Awareness Scale of Early Childhood Period (PASECP) was used to measure the sound awareness and sound discrimination skills of study group pre-post training. The test has 8 sub-dimensions. | Diagnostic test | Control group, Study group |
| Mismatch Negativity TestMismatch Negativity (MMN) was used to evaluate the central auditory system.The test was used for electrophysiological recordings of the study group.The standard stimulus presented as /ba/ (%80), and the rare stimulus presented as /da/ (%20) frequency. The onset (rise) and offset (fall) times of the stimuli are 10 ms, and the plateau time is 50 ms. The interval between stimuli for both responses was 1.1 ms. A 0.1-30 Hz filter was applied. The speech stimuli intensity was 70 dB SPL. Speech stimuli were presented at a 1-meter distance from the participant, with speakers placed at an angle of 0°. | Diagnostic test | Study group |
| Early Language Development (TELD-3)Test of Early Language Development (TELD-3) measured children's receptive and expressive language skills both group for inclusion criteria. | Diagnostic test | Control group, Study group |
Primary outcome
Change from Baseline in the phonological awareness skills at 3 Months
Time frame: baseline and 3 months
The Early Childhood Phonological Awareness Scale (PASECP) was used to measure sound awareness and sound discrimination skills of preschool children whose language age is between 60-72 months. The test has 8 sub-dimensions. There are 8 test items in the first sub-dimension and 10 test items in the other sub-dimensions, with a total of 78 test items. If the answers given by the children to the scale items are correct (1), if incorrect (0), they are coded into the answer key. The test is administered to children individually. The application time for each child takes approximately 15 minutes. High scores of the child indicate that his/her phonological awareness is good.
Change from Electrophysiological at 3 Months
Time frame: baseline and 3 months
Mismatch Negativity (MMN) was used to evaluate the central auditory system. Neuron-Spectrum-5 (4/EPM) (Neurosoft, Ivanoco, Russia) was used for the electrophysiological recordings of the study group. Speech stimuli were used as stimuli. Amplitude and latency changes were observed in the Mismatch Negativity test before and after the training. The increase in amplitudes and shortening of latencies after training indicate that the central auditory system has developed.
Change from baseline in the spectral discrimination ability at 3 Months
Time frame: baseline and 3 months
Spectral-Temporally Modulated Ripple Test (SMRT) was used to assess the spectral discrimination ability of the study group. The test was performed using SMRT software. Waveform broadband noise with spectral-temporal modulation was used. In each trial, three ripple sounds were presented. Two stimuli were reference signals with an intensity of 20 ripple/octave (rpo) and another stimulus was a target signal with a lower rpo intensity. The initial intensity of the target signal was 0.5 rpo and was replaced by a step size of 0.2 rpo. Adaptive running terminated after ten reverses.Spectral-Temporally Modulated Ripple Test was calculated over the last six reversals. Three runs were completed for each child, and the final threshold was determined by averaging the three runs. Having a low rpo value was an indication of good spectral resolution of the children.
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 16 Sep 2022.
- Background: PubMed 12952403Carroll JM, Snowling MJ, Hulme C, Stevenson J. The development of phonological awareness in preschool children. Dev Psychol. 2003 Sep;39(5):913-23. doi: 10.1037/0012-1649.39.5.913.
- 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.
- Background: PubMed 11409857Ching TY, Dillon H, Katsch R, Byrne D. Maximizing effective audibility in hearing aid fitting. Ear Hear. 2001 Jun;22(3):212-24. doi: 10.1097/00003446-200106000-00005.
- Background: PubMed 26968046Soleymani Z, Mahmoodabadi N, Nouri MM. Language skills and phonological awareness in children with cochlear implants and normal hearing. Int J Pediatr Otorhinolaryngol. 2016 Apr;83:16-21. doi: 10.1016/j.ijporl.2016.01.013. Epub 2016 Jan 25.
- Results publication: PubMed 30200479Christiner M, Reiterer SM. Early Influence of Musical Abilities and Working Memory on Speech Imitation Abilities: Study with Pre-School Children. Brain Sci. 2018 Sep 1;8(9):169. doi: 10.3390/brainsci8090169.
- Results publication: PubMed 12408958Anvari SH, Trainor LJ, Woodside J, Levy BA. Relations among musical skills, phonological processing, and early reading ability in preschool children. J Exp Child Psychol. 2002 Oct;83(2):111-30. doi: 10.1016/s0022-0965(02)00124-8.
- Results publication: PubMed 29335454Choi JE, Won JH, Kim CH, Cho YS, Hong SH, Moon IJ. Relationship between spectrotemporal modulation detection and music perception in normal-hearing, hearing-impaired, and cochlear implant listeners. Sci Rep. 2018 Jan 15;8(1):800. doi: 10.1038/s41598-017-17350-w.
- Results publication: PubMed 33268013Engstrom E, Kallioinen P, Nakeva von Mentzer C, Lindgren M, Sahlen B, Lyxell B, Ors M, Uhlen I. Auditory event-related potentials and mismatch negativity in children with hearing loss using hearing aids or cochlear implants - A three-year follow-up study. Int J Pediatr Otorhinolaryngol. 2021 Jan;140:110519. doi: 10.1016/j.ijporl.2020.110519. Epub 2020 Nov 24.
- Results publication: PubMed 29708065DiNino M, Arenberg JG. Age-Related Performance on Vowel Identification and the Spectral-temporally Modulated Ripple Test in Children With Normal Hearing and With Cochlear Implants. Trends Hear. 2018 Jan-Dec;22:2331216518770959. doi: 10.1177/2331216518770959.
- Results publication: PubMed 31360248Fernandes NM, Gil D, Azevedo MF. Mismatch Negativity in Children with Cochlear Implant. Int Arch Otorhinolaryngol. 2019 Jul;23(3):e292-e298. doi: 10.1055/s-0039-1688967. Epub 2019 May 28.
- Results publication: PubMed 30956696Ferreira DA, Bueno CD, de Costa SS, Sleifer P. Mismatch Negativity in Children: Reference Values. Int Arch Otorhinolaryngol. 2019 Apr;23(2):142-146. doi: 10.1055/s-0038-1667313. Epub 2018 Oct 24.
- Results publication: PubMed 29716437Gifford RH, Noble JH, Camarata SM, Sunderhaus LW, Dwyer RT, Dawant BM, Dietrich MS, Labadie RF. The Relationship Between Spectral Modulation Detection and Speech Recognition: Adult Versus Pediatric Cochlear Implant Recipients. Trends Hear. 2018 Jan-Dec;22:2331216518771176. doi: 10.1177/2331216518771176.
- Davis, M. M. (2019). Rhythms and Reading : Applying Literacy to the Music Classroom.Link provided by the sponsor.
- DuBois, G. E. (2021). Using Group Music Activities with Families to Support School-Readiness Skills in Preschool Children with Hearing Loss. ProQuest Dissertations and Theses, 6(1), 160.Link provided by the sponsor.
- Phelps, S. (2003). Phonological Awareness Training in a Preschool Classroom of Typically Developing Children. Electronic Theses and Dissertations.Link provided by the sponsor.
- Individual participant dataSharing planned: No. The IPD available upon reasonable request to the other authors
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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.
Büşra Yılanlı, Msc principal investigator
Uskudar University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music-Integrated Phonological Awareness training program, Spectral-Temporally Modulated Ripple Test (SMRT) and The Phonological Awareness Scale of Early Childhood Period (PASECP) in people with Telerehabilitation, run by Uskudar University at 2 sites 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 11 inclusion and 3 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 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change from Baseline in the phonological awareness skills at 3 Months (time frame: baseline and 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 NCT05543031, which also lists 28 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 16 Sep 2022.