Auditory Processing DisorderNCT02353091
Effects of Remote Microphone Hearing Aids on Children With Auditory Processing Disorder
A study testing Remote Microphone Hearing Aids in people with Auditory Processing Disorder, run by University College, London.
Trial summary
Auditory Processing Disorder (APD) is a disorder where the functions of the ear are normal, but the person has difficulty identifying or discriminating sounds and experiences listening difficulties in noise. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Auditory Processing Disorder
- What is being tested?
- Remote Microphone Hearing Aids
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Normal audiogram.
- Diagnosis of APD based on clinical tests administered by qualified audiologists as per the clinic's diagnosis protocol.
- No neurological or pervasive disorder or developmental delay (e.g. Attention Deficit Hyperactivity Disorder, epilepsy, Autism Spectrum Disorder, Developmental Language Disorder, Down Syndrome).
- Non-verbal cognitive ability score of 85 or greater.
- Ages between 7-12 years.
- Native English speakers.
- No prior use of RMHAs.
Who cannot join
- Any violation of the above conditions.
About this study
Official title: Effects of Remote Microphone Hearing Aids on Classroom Listening, Spatial Listening, and Attention in School-Aged Children With Auditory Processing Disorder
Auditory Processing Disorder (APD) is a disorder where the functions of the ear are normal, but the person has difficulty identifying or discriminating sounds and experiences listening difficulties in noise. Remote Microphone Hearing Aids (RMHAs) are wireless listening devices that pick up the speaker's voice and transmit it to a receiver in the listener's ear. In this way, the negative effects of ambient noise, distance from speaker and reverberation are reduced.
The research questions are whether RMHAs improve classroom listening, listening in noise performance, listening in spatialised noise and auditory attention, in children with APD. We hypothesize that RMHA use will lead to improved classroom listening and improved speech-in-noise skills after 6 months of RMHA use. Additionally, we hypothesise that listening in spatialised noise and attention skills will remain unchanged following the intervention period.
Twenty-six (26) children aged 7-12 with a diagnosis of an APD from the Great Ormond Street Hospital Audiology clinic were included in the study.
Read the detailed description
Auditory Processing Disorder (APD) is a disorder where the functions of the ear (outer, middle, inner) are normal but the person has difficulty identifying or discriminating sounds (1). For children with APD it is particularly difficult to hear when the listening conditions are not ideal. For example, when there is background noise it becomes really challenging to focus on the speaker. Two other factors that influence their hearing ability are reverberation and the distance from the speaker (2). Some symptoms reported for APD are listening difficulties in background noise, attention and memory problems, and distractibility (3,4). Children with APD have worse skills in speech perception in noise compared to typically developing children (5,6) and have also have poorer sustained auditory attention compared to children suspected of APD (7).
Remote Microphone Hearing Aids (RMHAs) are a management approach recommended for children with APD. These are wireless listening devices that pick up the speaker's voice and transmit it to a receiver in the listener's ear. The use of this system helps improve the signal-to-noise ratio for children and bypasses the negative effects of background noise and reverberation in the classroom (2,8,9). There have not been many studies, though. That looked into the effects of RMHA on children with APD. Previous research suggests that children with APD after a prolonged use of RMHAs benefit from improved speech perception which is possibly linked to an enhanced auditory system (9). Adding to that, children with APD have shown improved speech in noise perception when using the RMHA, hence emphasizing the advantages of the device in discriminating speech in background noise (9,10).
Sustained attention and the ability of children with APD to listen in spatialised noise after RMHA use has been examined by one study (10). It did not show improvement (unaided) in any of the two tests. However, this was a non-randomised trial that did not use a control group. As the central point of this study will be the use of the RMHA by children with APD for 6 months, it is expected that the findings could add valuable information on the subject.
Aim and hypotheses The aim of the study is to examine the effect of a 6-month RMHA use on self-reported listening in the classroom, speech perception in noise, speech perception in spatialised noise and on attention skills.
Hypotheses:
- Children with APD who use RMHAs will show greater improvements in classroom listening, listening in noise and sustained auditory attention (unaided) after 6 months of RMHA use in comparison to the APD control group. ii. Children with APD who use the RMHA will not show greater improvements in listening in spatialised speech noise and divided and visual attention measures after 6 months of RMHA use in comparison to the APD control group.
Research Design and Methodology Participants and Recruitment We recruited 26 children aged 7-12 years. All children have been diagnosed and referred from the Auditory Processing Disorders Clinic at Great Ormond Street Hospital. The total sample size was decided using this power sample: N = 24 (total sample size) calculated using the F test for repeated measures between-within interaction ANOVA based on an estimated 0.5 effect size f(U), 80% power, at 5% significance, using 2 groups and 3 measurement points. Accounting for a 10% loss due to follow-up, the final study sample size comprised 26 children.
Inclusion criteria:
- Diagnosis of APD based on clinical tests administered by qualified audiologists as per the clinic's diagnosis protocol.
- No neurological or pervasive disorder or developmental delay (e.g. Attention Deficit Hyperactivity Disorder, epilepsy, Autism Spectrum Disorder, Developmental Language Disorder, Down Syndrome).
- Non-verbal cognitive ability score of 85 or greater.
- Ages between 7-12 years.
- Native English speakers.
- No prior use of RMHAs. Subjects were semi-randomly assigned to each of two intervention arms. The two groups were stratified for age and balanced for gender.
Children were given RMHAs to use at school and were compared to the control that did not use any intervention for the study period. Children were enrolled in the study for 6 months. All groups were tested before the start of the RMHA intervention, after 3 months, and at the end of the study (after 6 months).
Explanation of each test:
- A hearing test (Pure Tone Audiometry approx. 10mins). To determine their hearing is normal.
- Non-verbal IQ test (Weschler test of non-verbal intelligence). To be performed by the PhD Student. (approx. 15mins). To assess determine whether their intelligence level is above normal.
- Listening in spatialised noise test (LiSN-S, approx. 15mins). To be administered through the use of headphones by the PhD student. To determine their listening in spatialised speech noise abilities.
- The Test of Everyday Attention for Children (TEACh). To be conducted as play type activities by the PhD student after receiving sufficient training by the clinical psychologist. (approx. 45mins possibly cut down to 30mins). To assess their attention.
- Two questionnaires to be filled by the children's parents.
- The Children's Communication Checklist-2 (CCC-2). A 70-item questionnaire which screens for communication problems (including language disorders and autism).
- The Children's Auditory Performance Scale (CHAPS). It assesses aspects of children's listening.
- One questionnaire to be completed by the children (Listening Inventory For Education-Revised [LIFE-R] for assessing their listening difficulty.
Data analysis:
Data were analysed in SPSS statistics software, using mixed ANOVA. Group was the between-subjects factor and time was the within-subjects factor.
Ethical issues
School and teacher involvement:
The teachers of the children who received the RMHA were provided with an information sheet and consent form and were required to wear the microphone (which picks up the teacher's voice and transmits it wirelessly to the ear receivers in the child's ear) for the duration of lecture-based subjects. Remote microphone hearing aids are generally beingg provided (funded by the school budget) to some children after clinical recommendations and this is not an unusual situation within the school environment.
We liaised with the teacher of the school to ensure that the school was aware that the student has been issued with the RMHA. A general guide for the system was made available in addition to information conveyed by the PhD student.
Informed consent:
The child's parents were given detailed written information and consent forms to sign. They were given up to a week to study and decide whether they wished for their child to participate in the study. They were only allowed to take part once they have understood the purpose and procedures of the study and they signed the consent forms. In addition, children were also given information sheets adjusted to their age. Written assent from children in the presence of their parents or carers was sought.
Rights to withdraw from the study:
This was outlined on both the information sheet and consent form and explained verbally during test visits. This information stated that participants were allowed to withdraw from the study at any point should they wished to. Withdrawal from the study did not involve any penalty or loss of benefit to them - this information was clearly underlined at the information sheet and verbally communicated.
Data protection:
Parents of the participants and the participants were informed that their information was anonymised and kept confidential. Data was anonymised prior to analysis by the use of participant codes. Storage of the data was in accordance with the data protection act 1998.
Other issues:
None of these tests were invasive or unpleasant, and they were conducted in comfortable sound levels (slightly higher than the usual conversational level).
References
- Dawes P, Bishop DVM. Auditory Processing Disorder in Relation to Developmental Disorders of Language, Communication and Attention: A Review and Critique. Int J Lang Commun Disord [Internet]. 2009 [cited 2014 Apr 1];44(4):440-65. Available from: http://www.ncbi.nlm.nih.gov/pubmed/19925352
- Keith WJ, Purdy SC. Assistive and Therapeutic Effects of Amplification for Auditory Processing Disorder. Semin Hear [Internet]. 2014;35(1):27-38. Available from: https://www.thieme-connect.com/products/ejournals/html/10.1055/s-0033-1363522
- American Speech-Language-Hearing Association. (Central) Auditory Processing Disorders. Technical Report [Internet]. American Speech-Language-Hearing Association. 2005 [cited 2019 Aug 6]. Available from: http://www.asha.org/policy/TR2005-00043/
- American Academy of Audiology. American Academy of Audiology Clinical Practice Guidelines. Diagnosis, Treatment and Management of Children and Adults with Central Auditory Processing Disorder [Internet]. American Academy of Audiology. 2010 [cited 2019 Aug 6]. p. 1-51. Available from: http://www.audiology.org/publications-resources/document-library/central-auditory-processing-disorder
- Lagacé J, Jutras B, Giguère C, Gagné J-P. Speech Perception in Noise: Exploring the Effect of Linguistic Context in Children With and Without Auditory Processing Disorder. Int J Audiol [Internet]. 2011;50(6):385-95. Available from: https://www.ncbi.nlm.nih.gov/pubmed/21599614
- Rocha-Muniz CN, Zachi EC, Teixeira RAA, Ventura DF, Befi-Lopes DM, Schochat E. Association Between Language Development and Auditory Processing Disorders. Braz J Otorhinolaryngol [Internet]. 2014;80(3):231-6. Available from: http://www.ncbi.nlm.nih.gov/pubmed/25153108
- Allen P, Allan C. Auditory Processing Disorders: Relationship to Cognitive Processes and Underlying Auditory Neural Integrity. Int J Pediatr Otorhinolaryngol [Internet]. 2014;78(2):198-208. Available from: http://dx.doi.org/10.1016/j.ijporl.2013.10.048
- British Society of Audiology. Practice Guidance. An Overview of Current Management of Auditory Processing Disorder (APD) [Internet]. British Society of Audiology. 2011 [cited 2019 Aug 6]. p. 1-60. Available from: http://www.thebsa.org.uk/docs/docsfromold/BSA_APD_Management_1Aug11_FINAL_amended17Oct11.pdf
- Johnston KN, John AB, Kreisman N V, Hall III JW, Crandell CC. Multiple Benefits of Personal FM System use by Children with Auditory Processing Disorder (APD). Int J Audiol [Internet]. 2009 Jan;48(6):371-83. Available from: http://www.ncbi.nlm.nih.gov/pubmed/19925345
- Smart JL, Purdy SC, Kelly AS. Impact of Personal Frequency Modulation Systems on Behavioral and Cortical Auditory Evoked Potential Measures of Auditory Processing and Classroom Listening in School-Aged Children with Auditory Processing Disorder. J Am Acad Audiol [Internet]. 2018;19:1-19. Available from: http://www.ingentaconnect.com/content/10.3766/jaaa.16074
- Conditions
- Auditory Processing Disorder
- Being tested
- Remote Microphone Hearing Aids
- Medical subject headings
- Auditory Perceptual Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Microphone Hearing AidsDevice
The ear receivers connect wirelessly with the microphone being worn by the teacher within a range of 25m.
| Study group | Role | What they receive |
|---|---|---|
| APD Control Group | No intervention | Comprised 13 children diagnosed with APD and acts as a control without using any form of intervention. |
| APD Intervention Group | Experimental | Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing AId intervention at the start of the study, after baseline testing, and used for 6 months. Receives: Device: Remote Microphone Hearing Aids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Listening Inventory For Education Revised (LIFE-R) - Total Score
Children questionnaire measured in raw scores. This is the total score of 9 questions on a likert scale from 0 to 5. Thus, this is the summed score. Therefore, minimum value 0, maximum value 45. Higher scores mean better outcome.
Measured: Baseline to 6 months
Listening in Spatialised Noise - Sentences Test (LiSN-S) - Low-cue Speech Reception Threshold Condition
Speech in noise test measured in z scores. Minimum value -2, maximum value +2. Higher scores mean better outcome. Z scores are automatically calculated in the computer test software based on normative sample data on decibel (dB) measures.
Measured: Baseline to 6 months
Listening in Spatialised Noise - Sentences Test (LiSN-S) - High-cue Speech Reception Threshold Condition
Speech in noise test measured in z scores. Minimum value -2, maximum value +2. Higher scores mean better outcome. Z scores are automatically calculated in the computer test software based on normative sample data on decibel (dB) measures.
Measured: 6 months
Listening in Spatialised Noise - Sentences Test (LiSN-S) - Talker Advantage Condition
Speech in noise test measured in z scores. Minimum value -2, maximum value +2. Higher scores mean better outcome. Z scores are automatically calculated in the computer test software based on normative sample data on decibel (dB) measures.
Measured: Baseline to 6 months
Listening in Spatialised Noise - Sentences Test (LiSN-S) - Spatial Advantage Condition
Speech in noise test measured in z scores. Minimum value -2, maximum value +2. Higher scores mean better outcome. Z scores are automatically calculated in the computer test software based on normative sample data on decibel (dB) measures.
Measured: Baseline to 6 months
Listening in Spatialised Noise - Sentences Test (LiSN-S) - Total Advantage Condition
Speech in noise test measured in z scores. Minimum value -2, maximum value +2. Higher scores mean better outcome. Z scores are automatically calculated in the computer test software based on normative sample data on decibel (dB) measures.
Measured: Baseline to 6 months
Secondary outcomes (4)
Test of Everyday Attention for Children TEACh - Sustained Auditory Attention Subscale
A validated attention test to test children's auditory attention. Measured on scaled scores. Minimum value 1, maximum value 19. Higher scores mean better outcome.
Measured: Baseline to 6 months
Test of Everyday Attention for Children TEACh - Divided Auditory-Visual Attention Subscale
A validated attention test to test children's auditory-visual attention. Measured on scaled scores. Minimum value 1, maximum value 19. Higher scores mean better outcome.
Measured: Baseline to 6 months
Test of Everyday Attention for Children TEACh - Selective Visual Attention Subscale
A validated attention test to test children's visual attention. Measured on scaled scores. Minimum value 1, maximum value 19. Higher scores mean better outcome.
Measured: Baseline to 6 months
Test of Everyday Attention for Children TEACh - Divided Auditory Attention Subscale
A validated attention test to test children's auditory attention. Measured on scaled scores. Minimum value 1, maximum value 19. Higher scores mean better outcome.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startMay 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Auditory Processing DisorderStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- GN Resound
- Responsible party
- Sponsor
- Investigators
- Doris-Eva Bamiou, MD MSc PhD, Principal investigator, UCL Ear Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02353091
- Sponsor's protocol ID
- 14/0333
- Status last verified
- Mar 2020
- First submitted
- 27 Jan 2015
- Last updated
- 5 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Dawes P, Bishop D. Auditory processing disorder in relation to developmental disorders of language, communication and attention: a review and critique. Int J Lang Commun Disord. 2009 Jul-Aug;44(4):440-65. doi: 10.1080/13682820902929073.
PubMed 19925352Lagace J, Jutras B, Giguere C, Gagne JP. Speech perception in noise: exploring the effect of linguistic context in children with and without auditory processing disorder. Int J Audiol. 2011 Jun;50(6):385-95. doi: 10.3109/14992027.2011.553204.
PubMed 21599614Rocha-Muniz CN, Zachi EC, Teixeira RA, Ventura DF, Befi-Lopes DM, Schochat E. Association between language development and auditory processing disorders. Braz J Otorhinolaryngol. 2014 May-Jun;80(3):231-6. doi: 10.1016/j.bjorl.2014.01.002.
PubMed 25153108Allen P, Allan C. Auditory processing disorders: relationship to cognitive processes and underlying auditory neural integrity. Int J Pediatr Otorhinolaryngol. 2014 Feb;78(2):198-208. doi: 10.1016/j.ijporl.2013.10.048. Epub 2013 Nov 20.
PubMed 24370466Johnston KN, John AB, Kreisman NV, Hall JW 3rd, Crandell CC. Multiple benefits of personal FM system use by children with auditory processing disorder (APD). Int J Audiol. 2009;48(6):371-83. doi: 10.1080/14992020802687516.
PubMed 19925345Smart JL, Purdy SC, Kelly AS. Impact of Personal Frequency Modulation Systems on Behavioral and Cortical Auditory Evoked Potential Measures of Auditory Processing and Classroom Listening in School-Aged Children with Auditory Processing Disorder. J Am Acad Audiol. 2018 Jul/Aug;29(7):568-586. doi: 10.3766/jaaa.16074.
PubMed 29988006Stavrinos G, Iliadou VV, Pavlou M, Bamiou DE. Remote Microphone Hearing Aid Use Improves Classroom Listening, Without Adverse Effects on Spatial Listening and Attention Skills, in Children With Auditory Processing Disorder: A Randomised Controlled Trial. Front Neurosci. 2020 Aug 21;14:904. doi: 10.3389/fnins.2020.00904. eCollection 2020.
PubMed 32973443
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Remote Microphone Hearing Aids on Classroom Listening, Spatial Listening, and Attention in School-Aged Children With Auditory Processing Disorder
- ClinicalTrials.gov ID
- NCT02353091
- Acronym / sponsor ID
- 14/0333
- Conditions
- Auditory Processing Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- GN Resound
- Study start
- May 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 2 Feb 2015 (estimated)
- Results
- Posted 27 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Auditory Processing Disorder (APD) is a disorder where the functions of the ear are normal, but the person has difficulty identifying or discriminating sounds and experiences listening difficulties in noise. Remote Microphone Hearing Aids (RMHAs) are wireless listening devices that pick up the speaker's voice and transmit it to a receiver in the listener's ear. In this way, the negative effects of ambient noise, distance from speaker and reverberation are reduced.
The research questions are whether RMHAs improve classroom listening, listening in noise performance, listening in spatialised noise and auditory attention, in children with APD. We hypothesize that RMHA use will lead to improved classroom listening and improved speech-in-noise skills after 6 months of RMHA use. Additionally, we hypothesise that listening in spatialised noise and attention skills will remain unchanged following the intervention period.
Twenty-six (26) children aged 7-12 with a diagnosis of an APD from the Great Ormond Street Hospital Audiology clinic were included in the study.
Detailed description
Auditory Processing Disorder (APD) is a disorder where the functions of the ear (outer, middle, inner) are normal but the person has difficulty identifying or discriminating sounds (1). For children with APD it is particularly difficult to hear when the listening conditions are not ideal. For example, when there is background noise it becomes really challenging to focus on the speaker. Two other factors that influence their hearing ability are reverberation and the distance from the speaker (2). Some symptoms reported for APD are listening difficulties in background noise, attention and memory problems, and distractibility (3,4). Children with APD have worse skills in speech perception in noise compared to typically developing children (5,6) and have also have poorer sustained auditory attention compared to children suspected of APD (7).
Remote Microphone Hearing Aids (RMHAs) are a management approach recommended for children with APD. These are wireless listening devices that pick up the speaker's voice and transmit it to a receiver in the listener's ear. The use of this system helps improve the signal-to-noise ratio for children and bypasses the negative effects of background noise and reverberation in the classroom (2,8,9). There have not been many studies, though. That looked into the effects of RMHA on children with APD. Previous research suggests that children with APD after a prolonged use of RMHAs benefit from improved speech perception which is possibly linked to an enhanced auditory system (9). Adding to that, children with APD have shown improved speech in noise perception when using the RMHA, hence emphasizing the advantages of the device in discriminating speech in background noise (9,10).
Sustained attention and the ability of children with APD to listen in spatialised noise after RMHA use has been examined by one study (10). It did not show improvement (unaided) in any of the two tests. However, this was a non-randomised trial that did not use a control group. As the central point of this study will be the use of the RMHA by children with APD for 6 months, it is expected that the findings could add valuable information on the subject.
Aim and hypotheses The aim of the study is to examine the effect of a 6-month RMHA use on self-reported listening in the classroom, speech perception in noise, speech perception in spatialised noise and on attention skills.
Hypotheses:
- Children with APD who use RMHAs will show greater improvements in classroom listening, listening in noise and sustained auditory attention (unaided) after 6 months of RMHA use in comparison to the APD control group. ii. Children with APD who use the RMHA will not show greater improvements in listening in spatialised speech noise and divided and visual attention measures after 6 months of RMHA use in comparison to the APD control group.
Research Design and Methodology Participants and Recruitment We recruited 26 children aged 7-12 years. All children have been diagnosed and referred from the Auditory Processing Disorders Clinic at Great Ormond Street Hospital. The total sample size was decided using this power sample: N = 24 (total sample size) calculated using the F test for repeated measures between-within interaction ANOVA based on an estimated 0.5 effect size f(U), 80% power, at 5% significance, using 2 groups and 3 measurement points. Accounting for a 10% loss due to follow-up, the final study sample size comprised 26 children.
Inclusion criteria:
- Diagnosis of APD based on clinical tests administered by qualified audiologists as per the clinic's diagnosis protocol.
- No neurological or pervasive disorder or developmental delay (e.g. Attention Deficit Hyperactivity Disorder, epilepsy, Autism Spectrum Disorder, Developmental Language Disorder, Down Syndrome).
- Non-verbal cognitive ability score of 85 or greater.
- Ages between 7-12 years.
- Native English speakers.
- No prior use of RMHAs. Subjects were semi-randomly assigned to each of two intervention arms. The two groups were stratified for age and balanced for gender.
Children were given RMHAs to use at school and were compared to the control that did not use any intervention for the study period. Children were enrolled in the study for 6 months. All groups were tested before the start of the RMHA intervention, after 3 months, and at the end of the study (after 6 months).
Explanation of each test:
- A hearing test (Pure Tone Audiometry approx. 10mins). To determine their hearing is normal.
- Non-verbal IQ test (Weschler test of non-verbal intelligence). To be performed by the PhD Student. (approx. 15mins). To assess determine whether their intelligence level is above normal.
- Listening in spatialised noise test (LiSN-S, approx. 15mins). To be administered through the use of headphones by the PhD student. To determine their listening in spatialised speech noise abilities.
- The Test of Everyday Attention for Children (TEACh). To be conducted as play type activities by the PhD student after receiving sufficient training by the clinical psychologist. (approx. 45mins possibly cut down to 30mins). To assess their attention.
- Two questionnaires to be filled by the children's parents.
- The Children's Communication Checklist-2 (CCC-2). A 70-item questionnaire which screens for communication problems (including language disorders and autism).
- The Children's Auditory Performance Scale (CHAPS). It assesses aspects of children's listening.
- One questionnaire to be completed by the children (Listening Inventory For Education-Revised [LIFE-R] for assessing their listening difficulty.
Data analysis:
Data were analysed in SPSS statistics software, using mixed ANOVA. Group was the between-subjects factor and time was the within-subjects factor.
Ethical issues
School and teacher involvement:
The teachers of the children who received the RMHA were provided with an information sheet and consent form and were required to wear the microphone (which picks up the teacher's voice and transmits it wirelessly to the ear receivers in the child's ear) for the duration of lecture-based subjects. Remote microphone hearing aids are generally beingg provided (funded by the school budget) to some children after clinical recommendations and this is not an unusual situation within the school environment.
We liaised with the teacher of the school to ensure that the school was aware that the student has been issued with the RMHA. A general guide for the system was made available in addition to information conveyed by the PhD student.
Informed consent:
The child's parents were given detailed written information and consent forms to sign. They were given up to a week to study and decide whether they wished for their child to participate in the study. They were only allowed to take part once they have understood the purpose and procedures of the study and they signed the consent forms. In addition, children were also given information sheets adjusted to their age. Written assent from children in the presence of their parents or carers was sought.
Rights to withdraw from the study:
This was outlined on both the information sheet and consent form and explained verbally during test visits. This information stated that participants were allowed to withdraw from the study at any point should they wished to. Withdrawal from the study did not involve any penalty or loss of benefit to them - this information was clearly underlined at the information sheet and verbally communicated.
Data protection:
Parents of the participants and the participants were informed that their information was anonymised and kept confidential. Data was anonymised prior to analysis by the use of participant codes. Storage of the data was in accordance with the data protection act 1998.
Other issues:
None of these tests were invasive or unpleasant, and they were conducted in comfortable sound levels (slightly higher than the usual conversational level).
References
- Dawes P, Bishop DVM. Auditory Processing Disorder in Relation to Developmental Disorders of Language, Communication and Attention: A Review and Critique. Int J Lang Commun Disord [Internet]. 2009 [cited 2014 Apr 1];44(4):440-65. Available from: http://www.ncbi.nlm.nih.gov/pubmed/19925352
- Keith WJ, Purdy SC. Assistive and Therapeutic Effects of Amplification for Auditory Processing Disorder. Semin Hear [Internet]. 2014;35(1):27-38. Available from: https://www.thieme-connect.com/products/ejournals/html/10.1055/s-0033-1363522
- American Speech-Language-Hearing Association. (Central) Auditory Processing Disorders. Technical Report [Internet]. American Speech-Language-Hearing Association. 2005 [cited 2019 Aug 6]. Available from: http://www.asha.org/policy/TR2005-00043/
- American Academy of Audiology. American Academy of Audiology Clinical Practice Guidelines. Diagnosis, Treatment and Management of Children and Adults with Central Auditory Processing Disorder [Internet]. American Academy of Audiology. 2010 [cited 2019 Aug 6]. p. 1-51. Available from: http://www.audiology.org/publications-resources/document-library/central-auditory-processing-disorder
- Lagacé J, Jutras B, Giguère C, Gagné J-P. Speech Perception in Noise: Exploring the Effect of Linguistic Context in Children With and Without Auditory Processing Disorder. Int J Audiol [Internet]. 2011;50(6):385-95. Available from: https://www.ncbi.nlm.nih.gov/pubmed/21599614
- Rocha-Muniz CN, Zachi EC, Teixeira RAA, Ventura DF, Befi-Lopes DM, Schochat E. Association Between Language Development and Auditory Processing Disorders. Braz J Otorhinolaryngol [Internet]. 2014;80(3):231-6. Available from: http://www.ncbi.nlm.nih.gov/pubmed/25153108
- Allen P, Allan C. Auditory Processing Disorders: Relationship to Cognitive Processes and Underlying Auditory Neural Integrity. Int J Pediatr Otorhinolaryngol [Internet]. 2014;78(2):198-208. Available from: http://dx.doi.org/10.1016/j.ijporl.2013.10.048
- British Society of Audiology. Practice Guidance. An Overview of Current Management of Auditory Processing Disorder (APD) [Internet]. British Society of Audiology. 2011 [cited 2019 Aug 6]. p. 1-60. Available from: http://www.thebsa.org.uk/docs/docsfromold/BSA_APD_Management_1Aug11_FINAL_amended17Oct11.pdf
- Johnston KN, John AB, Kreisman N V, Hall III JW, Crandell CC. Multiple Benefits of Personal FM System use by Children with Auditory Processing Disorder (APD). Int J Audiol [Internet]. 2009 Jan;48(6):371-83. Available from: http://www.ncbi.nlm.nih.gov/pubmed/19925345
- Smart JL, Purdy SC, Kelly AS. Impact of Personal Frequency Modulation Systems on Behavioral and Cortical Auditory Evoked Potential Measures of Auditory Processing and Classroom Listening in School-Aged Children with Auditory Processing Disorder. J Am Acad Audiol [Internet]. 2018;19:1-19. Available from: http://www.ingentaconnect.com/content/10.3766/jaaa.16074
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APD Control Group | No intervention | –Comprised 13 children diagnosed with APD and acts as a control without using any form of intervention. |
| APD Intervention Group | Experimental | Device: Remote Microphone Hearing AidsComprised 13 children diagnosed with APD and received the Remote Microphone Hearing AId intervention at the start of the study, after baseline testing, and used for 6 months. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Normal audiogram.
- Diagnosis of APD based on clinical tests administered by qualified audiologists as per the clinic's diagnosis protocol.
- No neurological or pervasive disorder or developmental delay (e.g. Attention Deficit Hyperactivity Disorder, epilepsy, Autism Spectrum Disorder, Developmental Language Disorder, Down Syndrome).
- Non-verbal cognitive ability score of 85 or greater.
- Ages between 7-12 years.
Key exclusion criteria (1 listed)
- Any violation of the above conditions.
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 |
|---|---|---|
| Remote Microphone Hearing AidsThe ear receivers connect wirelessly with the microphone being worn by the teacher within a range of 25m. | Device | APD Intervention Group |
Primary outcome
Listening Inventory For Education Revised (LIFE-R) - Total Score
Time frame: Baseline to 6 months
Children questionnaire measured in raw scores. This is the total score of 9 questions on a likert scale from 0 to 5. Thus, this is the summed score. Therefore, minimum value 0, maximum value 45. Higher scores mean better outcome.
Listening in Spatialised Noise - Sentences Test (LiSN-S) - Low-cue Speech Reception Threshold Condition
Time frame: Baseline to 6 months
Speech in noise test measured in z scores. Minimum value -2, maximum value +2. Higher scores mean better outcome. Z scores are automatically calculated in the computer test software based on normative sample data on decibel (dB) measures.
Listening in Spatialised Noise - Sentences Test (LiSN-S) - High-cue Speech Reception Threshold Condition
Time frame: 6 months
Speech in noise test measured in z scores. Minimum value -2, maximum value +2. Higher scores mean better outcome. Z scores are automatically calculated in the computer test software based on normative sample data on decibel (dB) measures.
Listening in Spatialised Noise - Sentences Test (LiSN-S) - Talker Advantage Condition
Time frame: Baseline to 6 months
Speech in noise test measured in z scores. Minimum value -2, maximum value +2. Higher scores mean better outcome. Z scores are automatically calculated in the computer test software based on normative sample data on decibel (dB) measures.
Listening in Spatialised Noise - Sentences Test (LiSN-S) - Spatial Advantage Condition
Time frame: Baseline to 6 months
Speech in noise test measured in z scores. Minimum value -2, maximum value +2. Higher scores mean better outcome. Z scores are automatically calculated in the computer test software based on normative sample data on decibel (dB) measures.
Listening in Spatialised Noise - Sentences Test (LiSN-S) - Total Advantage Condition
Time frame: Baseline to 6 months
Speech in noise test measured in z scores. Minimum value -2, maximum value +2. Higher scores mean better outcome. Z scores are automatically calculated in the computer test software based on normative sample data on decibel (dB) measures.
4 secondary outcomes
Test of Everyday Attention for Children TEACh - Sustained Auditory Attention Subscale
Time frame: Baseline to 6 months
Test of Everyday Attention for Children TEACh - Divided Auditory-Visual Attention Subscale
Time frame: Baseline to 6 months
Test of Everyday Attention for Children TEACh - Selective Visual Attention Subscale
Time frame: Baseline to 6 months
Test of Everyday Attention for Children TEACh - Divided Auditory Attention Subscale
Time frame: Baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19925352Dawes P, Bishop D. Auditory processing disorder in relation to developmental disorders of language, communication and attention: a review and critique. Int J Lang Commun Disord. 2009 Jul-Aug;44(4):440-65. doi: 10.1080/13682820902929073.
- Background: PubMed 21599614Lagace J, Jutras B, Giguere C, Gagne JP. Speech perception in noise: exploring the effect of linguistic context in children with and without auditory processing disorder. Int J Audiol. 2011 Jun;50(6):385-95. doi: 10.3109/14992027.2011.553204.
- Background: PubMed 25153108Rocha-Muniz CN, Zachi EC, Teixeira RA, Ventura DF, Befi-Lopes DM, Schochat E. Association between language development and auditory processing disorders. Braz J Otorhinolaryngol. 2014 May-Jun;80(3):231-6. doi: 10.1016/j.bjorl.2014.01.002.
- Background: PubMed 24370466Allen P, Allan C. Auditory processing disorders: relationship to cognitive processes and underlying auditory neural integrity. Int J Pediatr Otorhinolaryngol. 2014 Feb;78(2):198-208. doi: 10.1016/j.ijporl.2013.10.048. Epub 2013 Nov 20.
- Background: PubMed 19925345Johnston KN, John AB, Kreisman NV, Hall JW 3rd, Crandell CC. Multiple benefits of personal FM system use by children with auditory processing disorder (APD). Int J Audiol. 2009;48(6):371-83. doi: 10.1080/14992020802687516.
- Background: PubMed 29988006Smart JL, Purdy SC, Kelly AS. Impact of Personal Frequency Modulation Systems on Behavioral and Cortical Auditory Evoked Potential Measures of Auditory Processing and Classroom Listening in School-Aged Children with Auditory Processing Disorder. J Am Acad Audiol. 2018 Jul/Aug;29(7):568-586. doi: 10.3766/jaaa.16074.
- Derived from this study: PubMed 32973443Stavrinos G, Iliadou VV, Pavlou M, Bamiou DE. Remote Microphone Hearing Aid Use Improves Classroom Listening, Without Adverse Effects on Spatial Listening and Attention Skills, in Children With Auditory Processing Disorder: A Randomised Controlled Trial. Front Neurosci. 2020 Aug 21;14:904. doi: 10.3389/fnins.2020.00904. eCollection 2020.
- 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.
Doris-Eva Bamiou, MD MSc PhD principal investigator
UCL Ear Institute
Questions about this trial
What is this clinical trial studying?
A study testing Remote Microphone Hearing Aids in people with Auditory Processing Disorder, run by University College, London.
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 7 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 5 May 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?
Yes. Results are posted in the registry (first posted 27 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Listening Inventory For Education Revised (LIFE-R) - Total Score (time frame: Baseline to 6 months). The study lists 6 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 NCT02353091, which also lists 7 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 5 May 2020.