Effects of Remote Microphone Hearing Aids on Children With Auditory Processing Disorder
Primary Purpose
Auditory Processing Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Remote Microphone Hearing Aids
Sponsored by
About this trial
This is an interventional supportive care trial for Auditory Processing Disorder
Eligibility Criteria
Inclusion criteria:
- 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.
Exclusion criteria:
Any violation of the above conditions.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
APD Control Group
APD Intervention Group
Arm Description
Comprised 13 children diagnosed with APD and acts as a control without using any form of intervention.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT02353091
First Posted
January 27, 2015
Last Updated
April 27, 2020
Sponsor
University College, London
Collaborators
GN Resound
1. Study Identification
Unique Protocol Identification Number
NCT02353091
Brief Title
Effects of Remote Microphone Hearing Aids on Children With Auditory Processing Disorder
Official Title
Effects of Remote Microphone Hearing Aids on Classroom Listening, Spatial Listening, and Attention in School-Aged Children With Auditory Processing Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
Collaborators
GN Resound
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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:
i. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Auditory Processing Disorder
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
APD Control Group
Arm Type
No Intervention
Arm Description
Comprised 13 children diagnosed with APD and acts as a control without using any form of intervention.
Arm Title
APD Intervention Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Remote Microphone Hearing Aids
Intervention Description
The ear receivers connect wirelessly with the microphone being worn by the teacher within a range of 25m.
Primary Outcome Measure Information:
Title
Listening Inventory For Education Revised (LIFE-R) - Total Score
Description
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.
Time Frame
Baseline to 6 months
Title
Listening in Spatialised Noise - Sentences Test (LiSN-S) - Low-cue Speech Reception Threshold Condition
Description
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.
Time Frame
Baseline to 6 months
Title
Listening in Spatialised Noise - Sentences Test (LiSN-S) - High-cue Speech Reception Threshold Condition
Description
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.
Time Frame
6 months
Title
Listening in Spatialised Noise - Sentences Test (LiSN-S) - Talker Advantage Condition
Description
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.
Time Frame
Baseline to 6 months
Title
Listening in Spatialised Noise - Sentences Test (LiSN-S) - Spatial Advantage Condition
Description
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.
Time Frame
Baseline to 6 months
Title
Listening in Spatialised Noise - Sentences Test (LiSN-S) - Total Advantage Condition
Description
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.
Time Frame
Baseline to 6 months
Secondary Outcome Measure Information:
Title
Test of Everyday Attention for Children TEACh - Sustained Auditory Attention Subscale
Description
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.
Time Frame
Baseline to 6 months
Title
Test of Everyday Attention for Children TEACh - Divided Auditory-Visual Attention Subscale
Description
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.
Time Frame
Baseline to 6 months
Title
Test of Everyday Attention for Children TEACh - Selective Visual Attention Subscale
Description
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.
Time Frame
Baseline to 6 months
Title
Test of Everyday Attention for Children TEACh - Divided Auditory Attention Subscale
Description
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.
Time Frame
Baseline to 6 months
Other Pre-specified Outcome Measures:
Title
Children's Auditory Performance Scale - Noise Subscale
Description
Parental questionnaire measured in raw unstandardised scores. Minimum value is -5, maximum value is +1. Higher score means better outcome.
Time Frame
Baseline to 6 months
Title
Children's Auditory Performance Scale - Multiple Inputs Subscale
Description
Parental questionnaire measured in raw unstandardised scores. Minimum value is -5, maximum value is +1. Higher score means better outcome.
Time Frame
Baseline to 6 months
Title
Children's Auditory Performance Scale - Auditory Memory Sequencing Subscale
Description
Parental questionnaire measured in raw unstandardised scores. Minimum value is -5, maximum value is +1. Higher score means better outcome.
Time Frame
Baseline to 6 months
Title
Children's Auditory Performance Scale - Auditory Attention Span Subscale
Description
Parental questionnaire measured in raw unstandardised scores. Minimum value is -5, maximum value is +1. Higher score means better outcome.
Time Frame
Baseline to 6 months
Title
The Children's Communication Checklist - 2 - Standard Language Composite Score
Description
Parental questionnaire. Average composite of scaled scores are used to calculate the outcome, so units are scaled scores. Maximum value is 1, maximum value is 19. Higher score means better outcome.
Time Frame
6 months
Title
The Children's Communication Checklist - 2 - Non-Standard Language Composite Score
Description
Parental questionnaire. Average composite of scaled scores are used to calculate the outcome, so units are scaled scores. Maximum value is 1, maximum value is 19. Higher score means better outcome.
Time Frame
Baseline to 6 months
Title
Screening Instrument For Targeting Educational Risk Performance Scale - Attention Subscale
Description
Raw unstandardised score measured in Likert Scale (5 scales). Minimum score is 1, maximum score is 5. Higher score means better outcome. The three Attention Subscales are averaged to create one combined score.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
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.
Exclusion criteria:
Any violation of the above conditions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doris-Eva Bamiou, MD MSc PhD
Organizational Affiliation
UCL Ear Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19925352
Citation
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.
Results Reference
background
PubMed Identifier
21599614
Citation
Lagace 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.
Results Reference
background
PubMed Identifier
25153108
Citation
Rocha-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.
Results Reference
background
PubMed Identifier
24370466
Citation
Allen 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.
Results Reference
background
PubMed Identifier
19925345
Citation
Johnston 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.
Results Reference
background
PubMed Identifier
29988006
Citation
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. 2018 Jul/Aug;29(7):568-586. doi: 10.3766/jaaa.16074.
Results Reference
background
PubMed Identifier
32973443
Citation
Stavrinos 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.
Results Reference
derived
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Effects of Remote Microphone Hearing Aids on Children With Auditory Processing Disorder
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