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Effects of Remote Microphone Hearing Aids on Children With Auditory Processing Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02353091
Recruitment Status : Completed
First Posted : February 2, 2015
Results First Posted : April 27, 2020
Last Update Posted : May 5, 2020
Sponsor:
Collaborator:
GN Resound
Information provided by (Responsible Party):
University College, London

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Auditory Processing Disorder
Intervention Device: Remote Microphone Hearing Aids
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title APD Control Group APD Intervention Group
Hide Arm/Group Description Comprised 13 children diagnosed with APD and did not receive an intervention. Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
Period Title: Overall Study
Started 13 13
Completed 13 13
Not Completed 0 0
Arm/Group Title APD Control Group APD Intervention Group Total
Hide Arm/Group Description Comprised 13 children diagnosed with APD and rdid not receive an intervention. Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months. Total of all reporting groups
Overall Number of Baseline Participants 13 13 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 13 participants 13 participants 26 participants
116  (16.3) 115  (16.1) 115  (15.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
Female
4
  30.8%
4
  30.8%
8
  30.8%
Male
9
  69.2%
9
  69.2%
18
  69.2%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 13 participants 13 participants 26 participants
13 13 26
1.Primary Outcome
Title Listening Inventory For Education Revised (LIFE-R) - Total Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
An outlier at the 3-month time-point (at -3.25 SDs) was removed
Arm/Group Title APD Control Group APD Intervention Group
Hide Arm/Group Description:
Comprised of 13 children diagnosed with APD and does not receive any intervention.
Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
Overall Number of Participants Analyzed 12 13
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 30.91  (4.46) 28.30  (7.44)
3 months 33.33  (5.59) 35.61  (3.45)
6 months 30.83  (5.06) 33.30  (7.66)
2.Primary Outcome
Title Listening in Spatialised Noise - Sentences Test (LiSN-S) - Low-cue Speech Reception Threshold Condition
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title APD Control Group APD Intervention Group
Hide Arm/Group Description:
Comprised of 13 children diagnosed with APD and does not receive any intervention.
Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
Overall Number of Participants Analyzed 13 13
Mean (Standard Error)
Unit of Measure: z scores
Baseline -0.56  (0.90) -0.99  (1.12)
3 months -0.46  (1.43) -0.63  (1.61)
6 months -1.38  (3.33) -1.05  (1.51)
3.Primary Outcome
Title Listening in Spatialised Noise - Sentences Test (LiSN-S) - High-cue Speech Reception Threshold Condition
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
One outlier in the intervention group was found. Outlier was removed as participant had decreased focus and difficulty remaining seated during this condition.
Arm/Group Title APD Control Group APD Intervention Group
Hide Arm/Group Description:
Comprised of 13 children diagnosed with APD and did not receive any intervention.
Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
Overall Number of Participants Analyzed 13 12
Mean (Standard Deviation)
Unit of Measure: z scores
Baseline -0.83  (1.45) -1.27  (1.02)
3 months -0.70  (1.34) -0.60  (1.08)
6 months -1.23  (1.82) -0.68  (1.66)
4.Primary Outcome
Title Listening in Spatialised Noise - Sentences Test (LiSN-S) - Talker Advantage Condition
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title APD Control Group APD Intervention Group
Hide Arm/Group Description:
Comprised of 13 children diagnosed with APD and does not receive any intervention.
Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: z scores
Baseline -1.01  (1.14) -0.84  (0.80)
3 months -0.32  (1.00) -0.59  (0.82)
6 months -0.44  (1.11) -0.68  (0.93)
5.Primary Outcome
Title Listening in Spatialised Noise - Sentences Test (LiSN-S) - Spatial Advantage Condition
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title APD Control Group APD Intervention Group
Hide Arm/Group Description:
Comprised of 13 children diagnosed with APD and does not receive any intervention.
Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: z scores
Baseline -1.50  (1.54) -0.97  (1.07)
3 months -1.31  (1.41) -0.99  (1.57)
6 months -0.98  (1.76) -0.53  (1.35)
6.Primary Outcome
Title Listening in Spatialised Noise - Sentences Test (LiSN-S) - Total Advantage Condition
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
One outlier in the intervention group was found. Outlier was removed as participant had decreased focus and difficulty remaining seated during this condition.
Arm/Group Title APD Control Group APD Intervention Group
Hide Arm/Group Description:
Comprised of 13 children diagnosed with APD and does not receive any intervention.
Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
Overall Number of Participants Analyzed 13 12
Mean (Standard Deviation)
Unit of Measure: z scores
Baseline -0.56  (1.34) -0.94  (1.12)
3 months -0.52  (1.28) -0.47  (1.06)
6 months -0.63  (1.07) -0.30  (1.28)
7.Secondary Outcome
Title Test of Everyday Attention for Children TEACh - Sustained Auditory Attention Subscale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title APD Control Group APD Intervention Group
Hide Arm/Group Description:
Comprised 13 children diagnosed with APD and did not receive any intervention.
Comprised 13 children diagnosed with APD and received a Remotre Microphone Hearing Aid intervention after baseline testing and for 6 months.
Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: scaled scores
Baseline 9.76  (4.00) 6.30  (2.62)
3 months 7.76  (3.67) 6.61  (3.84)
6 months 8.23  (4.22) 5.76  (1.87)
8.Secondary Outcome
Title Test of Everyday Attention for Children TEACh - Divided Auditory-Visual Attention Subscale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title APD Control Group APD Intervention Group
Hide Arm/Group Description:
Comprised of 13 children diagnosed with APD and does not receive any intervention.
Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: scaled scores
Baseline 6.61  (3.17) 2.38  (2.39)
3 months 5.23  (2.83) 5.15  (3.67)
6 months 5.92  (3.25) 5.76  (2.16)
9.Secondary Outcome
Title Test of Everyday Attention for Children TEACh - Selective Visual Attention Subscale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title APD Control Group APD Intervention Group
Hide Arm/Group Description:
Comprised of 13 children diagnosed with APD and does not receive any intervention.
Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: scaled scores
Baseline 9.69  (2.01) 6.00  (2.85)
3 months 10.30  (3.61) 8.30  (2.71)
6 months 10.92  (1.93) 9.61  (2.32)
10.Secondary Outcome
Title Test of Everyday Attention for Children TEACh - Divided Auditory Attention Subscale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title APD Control Group APD Intervention Group
Hide Arm/Group Description:
Comprised of 13 children diagnosed with APD and does not receive any intervention.
Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: scaled scores
Baseline 9.15  (3.13) 6.53  (3.12)
3 months 8.61  (4.21) 6.76  (2.55)
6 months 8.69  (4.17) 6.07  (3.17)
11.Other Pre-specified Outcome
Title Children's Auditory Performance Scale - Noise Subscale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title APD Control Group APD Intervention Group
Hide Arm/Group Description:
Comprised 13 children diagnosed with APD that did not receive any intervention.
Comprised 13 children diagnosed with APD that received the Remote Microphone Hearing Aid intervention after baseline testing and used for 6 months.
Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline -2.85  (1.01) -3.29  (0.89)
3 months -2.36  (1.31) -2.82  (0.83)
6 months -2.19  (1.07) -2.95  (0.97)
12.Other Pre-specified Outcome
Title Children's Auditory Performance Scale - Multiple Inputs Subscale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title APD Control Group APD Intervention Group
Hide Arm/Group Description:
Comprised of 13 children diagnosed with APD and does not receive any intervention.
Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline -1.31  (0.99) -1.62  (1.21)
3 months -1.33  (1.09) -1.21  (1.00)
6 months -1.05  (1.14) -1.33  (1.41)
13.Other Pre-specified Outcome
Title Children's Auditory Performance Scale - Auditory Memory Sequencing Subscale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title APD Control Group APD Intervention Group
Hide Arm/Group Description:
Comprised of 13 children diagnosed with APD and does not receive any intervention.
Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline -1.77  (1.15) -2.63  (1.53)
3 months -2.24  (1.30) -2.06  (1.33)
6 months -2.14  (1.35) -2.51  (1.41)
14.Other Pre-specified Outcome
Title Children's Auditory Performance Scale - Auditory Attention Span Subscale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title APD Control Group APD Intervention Group
Hide Arm/Group Description:
Comprised of 13 children diagnosed with APD and does not receive any intervention.
Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline -1.34  (0.86) -1.84  (1.16)
3 months -1.62  (1.06) -1.57  (0.93)
6 months -1.46  (1.04) -1.77  (1.17)
15.Other Pre-specified Outcome
Title The Children's Communication Checklist - 2 - Standard Language Composite Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
One parent from intervention group did not complete any of the questionnaires, hence intervention group number analysed was 12.
Arm/Group Title APD Group 1 APD Group 2
Hide Arm/Group Description:

APD Group 1 is comprised of 13 children diagnosed with APD and receives the device from the beginning of the study.

Personal FM system

APD Group 2 is comprised of 13 children diagnosed with APD and receives the device 6 months later than APD Group 1.

Personal FM system

Overall Number of Participants Analyzed 13 12
Mean (Standard Deviation)
Unit of Measure: scaled scores
Baseline 5.82  (2.65) 5.44  (2.56)
3 months 6.03  (2.71) 5.39  (2.88)
6 months 6.50  (2.84) 5.58  (2.35)
16.Other Pre-specified Outcome
Title The Children's Communication Checklist - 2 - Non-Standard Language Composite Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
One parent from intervention group did not complete any of the questionnaires, hence intervention group number analysed was 12.
Arm/Group Title APD Control Group APD Intervention Group
Hide Arm/Group Description:
Comprised of 13 children diagnosed with APD and does not receive any intervention.
Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
Overall Number of Participants Analyzed 13 12
Mean (Standard Deviation)
Unit of Measure: scaled scores
Baseline 6.25  (2.82) 6.19  (2.66)
3 months 6.38  (2.87) 6.08  (2.60)
6 months 6.61  (3.06) 5.70  (2.83)
17.Other Pre-specified Outcome
Title Screening Instrument For Targeting Educational Risk Performance Scale - Attention Subscale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Only 5 questionnaires given to teachers were returned, all from the intervention group. The data for these 5 questionnaires are presented in the APD Group 2, as all 5 cases are from that group only. Group 1 has no data.
Arm/Group Title APD Group 1 APD Group 2
Hide Arm/Group Description:

APD Group 1 is comprised 13 children diagnosed with APD and acts as a control without using any form of intervention.

No intervention: No intervention is assigned

APD Group 2 is comprised 13 children diagnosed with APD and receives the intervention at the start of the study.

Remote Microphone Hearing Aids: The ear receivers connect wirelessly with the microphone being worn by the teacher within a range of 25m.

Overall Number of Participants Analyzed 0 5
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 2.33  (0.59)
6 months 2.79  (1.00)
Time Frame Adverse event data were collection for a period of 6 months.
Adverse Event Reporting Description The concern that spatial listening of children would be affected by the intervention was monitored through the use of the Listening in Spatialised Noise - Sentences test.
 
Arm/Group Title APD Control Group APD Intervention Group
Hide Arm/Group Description Comprised 13 children diagnosed with APD and did not receive any intervention. Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
All-Cause Mortality
APD Control Group APD Intervention Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%) 
Hide Serious Adverse Events
APD Control Group APD Intervention Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
APD Control Group APD Intervention Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%) 
Placebo, Hawthorne or observer bias effects may have influenced the results.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mr Georgios Stavrinos
Organization: UCL Ear Institute
Phone: 07856067517
EMail: georgios.stavrinos.13@ucl.ac.uk
Publications:
Layout table for additonal information
Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02353091    
Other Study ID Numbers: 14/0333
First Submitted: January 27, 2015
First Posted: February 2, 2015
Results First Submitted: October 15, 2018
Results First Posted: April 27, 2020
Last Update Posted: May 5, 2020