Trial Outcomes & Findings for Effects of Remote Microphone Hearing Aids on Children With Auditory Processing Disorder (NCT NCT02353091)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

26 participants

Primary outcome timeframe

Baseline to 6 months

Results posted on

2020-05-05

Participant Flow

Participant milestones

Participant milestones
Measure	APD Control Group Comprised 13 children diagnosed with APD and did not receive an intervention.	APD Intervention Group Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
Overall Study STARTED	13	13
Overall Study COMPLETED	13	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	APD Control Group n=13 Participants Comprised 13 children diagnosed with APD and rdid not receive an intervention.	APD Intervention Group n=13 Participants Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.	Total n=26 Participants Total of all reporting groups
Age, Continuous	116 Months STANDARD_DEVIATION 16.3 • n=13 Participants	115 Months STANDARD_DEVIATION 16.1 • n=13 Participants	115 Months STANDARD_DEVIATION 15.9 • n=26 Participants
Sex: Female, Male Female	4 Participants n=13 Participants	4 Participants n=13 Participants	8 Participants n=26 Participants
Sex: Female, Male Male	9 Participants n=13 Participants	9 Participants n=13 Participants	18 Participants n=26 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	13 participants n=13 Participants	13 participants n=13 Participants	26 participants n=26 Participants

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: An outlier at the 3-month time-point (at -3.25 SDs) was removed

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.

Outcome measures

Outcome measures
Measure	APD Control Group n=12 Participants Comprised of 13 children diagnosed with APD and does not receive any intervention.	APD Intervention Group n=13 Participants Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
Listening Inventory For Education Revised (LIFE-R) - Total Score Baseline	30.91 Units on a scale Standard Deviation 4.46	28.30 Units on a scale Standard Deviation 7.44
Listening Inventory For Education Revised (LIFE-R) - Total Score 3 months	33.33 Units on a scale Standard Deviation 5.59	35.61 Units on a scale Standard Deviation 3.45
Listening Inventory For Education Revised (LIFE-R) - Total Score 6 months	30.83 Units on a scale Standard Deviation 5.06	33.30 Units on a scale Standard Deviation 7.66

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	APD Control Group n=13 Participants Comprised of 13 children diagnosed with APD and does not receive any intervention.	APD Intervention Group n=13 Participants Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
Listening in Spatialised Noise - Sentences Test (LiSN-S) - Low-cue Speech Reception Threshold Condition 3 months	-0.46 z scores Standard Error 1.43	-0.63 z scores Standard Error 1.61
Listening in Spatialised Noise - Sentences Test (LiSN-S) - Low-cue Speech Reception Threshold Condition Baseline	-0.56 z scores Standard Error 0.90	-0.99 z scores Standard Error 1.12
Listening in Spatialised Noise - Sentences Test (LiSN-S) - Low-cue Speech Reception Threshold Condition 6 months	-1.38 z scores Standard Error 3.33	-1.05 z scores Standard Error 1.51

PRIMARY outcome

Timeframe: 6 months

Population: One outlier in the intervention group was found. Outlier was removed as participant had decreased focus and difficulty remaining seated during this 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.

Outcome measures

Outcome measures
Measure	APD Control Group n=13 Participants Comprised of 13 children diagnosed with APD and does not receive any intervention.	APD Intervention Group n=12 Participants Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
Listening in Spatialised Noise - Sentences Test (LiSN-S) - High-cue Speech Reception Threshold Condition 6 months	-1.23 z scores Standard Deviation 1.82	-0.68 z scores Standard Deviation 1.66
Listening in Spatialised Noise - Sentences Test (LiSN-S) - High-cue Speech Reception Threshold Condition Baseline	-0.83 z scores Standard Deviation 1.45	-1.27 z scores Standard Deviation 1.02
Listening in Spatialised Noise - Sentences Test (LiSN-S) - High-cue Speech Reception Threshold Condition 3 months	-0.70 z scores Standard Deviation 1.34	-0.60 z scores Standard Deviation 1.08

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	APD Control Group n=13 Participants Comprised of 13 children diagnosed with APD and does not receive any intervention.	APD Intervention Group n=13 Participants Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
Listening in Spatialised Noise - Sentences Test (LiSN-S) - Talker Advantage Condition Baseline	-1.01 z scores Standard Deviation 1.14	-0.84 z scores Standard Deviation 0.80
Listening in Spatialised Noise - Sentences Test (LiSN-S) - Talker Advantage Condition 3 months	-0.32 z scores Standard Deviation 1.00	-0.59 z scores Standard Deviation 0.82
Listening in Spatialised Noise - Sentences Test (LiSN-S) - Talker Advantage Condition 6 months	-0.44 z scores Standard Deviation 1.11	-0.68 z scores Standard Deviation 0.93

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	APD Control Group n=13 Participants Comprised of 13 children diagnosed with APD and does not receive any intervention.	APD Intervention Group n=13 Participants Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
Listening in Spatialised Noise - Sentences Test (LiSN-S) - Spatial Advantage Condition Baseline	-1.50 z scores Standard Deviation 1.54	-0.97 z scores Standard Deviation 1.07
Listening in Spatialised Noise - Sentences Test (LiSN-S) - Spatial Advantage Condition 3 months	-1.31 z scores Standard Deviation 1.41	-0.99 z scores Standard Deviation 1.57
Listening in Spatialised Noise - Sentences Test (LiSN-S) - Spatial Advantage Condition 6 months	-0.98 z scores Standard Deviation 1.76	-0.53 z scores Standard Deviation 1.35

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: One outlier in the intervention group was found. Outlier was removed as participant had decreased focus and difficulty remaining seated during this 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.

Outcome measures

Outcome measures
Measure	APD Control Group n=13 Participants Comprised of 13 children diagnosed with APD and does not receive any intervention.	APD Intervention Group n=12 Participants Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
Listening in Spatialised Noise - Sentences Test (LiSN-S) - Total Advantage Condition 6 months	-0.63 z scores Standard Deviation 1.07	-0.30 z scores Standard Deviation 1.28
Listening in Spatialised Noise - Sentences Test (LiSN-S) - Total Advantage Condition Baseline	-0.56 z scores Standard Deviation 1.34	-0.94 z scores Standard Deviation 1.12
Listening in Spatialised Noise - Sentences Test (LiSN-S) - Total Advantage Condition 3 months	-0.52 z scores Standard Deviation 1.28	-0.47 z scores Standard Deviation 1.06

SECONDARY outcome

Timeframe: Baseline to 6 months

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.

Outcome measures

Outcome measures
Measure	APD Control Group n=13 Participants Comprised of 13 children diagnosed with APD and does not receive any intervention.	APD Intervention Group n=13 Participants Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
Test of Everyday Attention for Children TEACh - Sustained Auditory Attention Subscale Baseline	9.76 scaled scores Standard Deviation 4.00	6.30 scaled scores Standard Deviation 2.62
Test of Everyday Attention for Children TEACh - Sustained Auditory Attention Subscale 3 months	7.76 scaled scores Standard Deviation 3.67	6.61 scaled scores Standard Deviation 3.84
Test of Everyday Attention for Children TEACh - Sustained Auditory Attention Subscale 6 months	8.23 scaled scores Standard Deviation 4.22	5.76 scaled scores Standard Deviation 1.87

SECONDARY outcome

Timeframe: Baseline to 6 months

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.

Outcome measures

Outcome measures
Measure	APD Control Group n=13 Participants Comprised of 13 children diagnosed with APD and does not receive any intervention.	APD Intervention Group n=13 Participants Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
Test of Everyday Attention for Children TEACh - Divided Auditory-Visual Attention Subscale Baseline	6.61 scaled scores Standard Deviation 3.17	2.38 scaled scores Standard Deviation 2.39
Test of Everyday Attention for Children TEACh - Divided Auditory-Visual Attention Subscale 3 months	5.23 scaled scores Standard Deviation 2.83	5.15 scaled scores Standard Deviation 3.67
Test of Everyday Attention for Children TEACh - Divided Auditory-Visual Attention Subscale 6 months	5.92 scaled scores Standard Deviation 3.25	5.76 scaled scores Standard Deviation 2.16

SECONDARY outcome

Timeframe: Baseline to 6 months

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.

Outcome measures

Outcome measures
Measure	APD Control Group n=13 Participants Comprised of 13 children diagnosed with APD and does not receive any intervention.	APD Intervention Group n=13 Participants Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
Test of Everyday Attention for Children TEACh - Selective Visual Attention Subscale Baseline	9.69 scaled scores Standard Deviation 2.01	6.00 scaled scores Standard Deviation 2.85
Test of Everyday Attention for Children TEACh - Selective Visual Attention Subscale 3 months	10.30 scaled scores Standard Deviation 3.61	8.30 scaled scores Standard Deviation 2.71
Test of Everyday Attention for Children TEACh - Selective Visual Attention Subscale 6 months	10.92 scaled scores Standard Deviation 1.93	9.61 scaled scores Standard Deviation 2.32

SECONDARY outcome

Timeframe: Baseline to 6 months

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.

Outcome measures

Outcome measures
Measure	APD Control Group n=13 Participants Comprised of 13 children diagnosed with APD and does not receive any intervention.	APD Intervention Group n=13 Participants Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
Test of Everyday Attention for Children TEACh - Divided Auditory Attention Subscale 6 months	8.69 scaled scores Standard Deviation 4.17	6.07 scaled scores Standard Deviation 3.17
Test of Everyday Attention for Children TEACh - Divided Auditory Attention Subscale Baseline	9.15 scaled scores Standard Deviation 3.13	6.53 scaled scores Standard Deviation 3.12
Test of Everyday Attention for Children TEACh - Divided Auditory Attention Subscale 3 months	8.61 scaled scores Standard Deviation 4.21	6.76 scaled scores Standard Deviation 2.55

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 6 months

Parental questionnaire measured in raw unstandardised scores. Minimum value is -5, maximum value is +1. Higher score means better outcome.

Outcome measures

Outcome measures
Measure	APD Control Group n=13 Participants Comprised of 13 children diagnosed with APD and does not receive any intervention.	APD Intervention Group n=13 Participants Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
Children's Auditory Performance Scale - Noise Subscale Baseline	-2.85 units on a scale Standard Deviation 1.01	-3.29 units on a scale Standard Deviation 0.89
Children's Auditory Performance Scale - Noise Subscale 3 months	-2.36 units on a scale Standard Deviation 1.31	-2.82 units on a scale Standard Deviation 0.83
Children's Auditory Performance Scale - Noise Subscale 6 months	-2.19 units on a scale Standard Deviation 1.07	-2.95 units on a scale Standard Deviation 0.97

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 6 months

Parental questionnaire measured in raw unstandardised scores. Minimum value is -5, maximum value is +1. Higher score means better outcome.

Outcome measures

Outcome measures
Measure	APD Control Group n=13 Participants Comprised of 13 children diagnosed with APD and does not receive any intervention.	APD Intervention Group n=13 Participants Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
Children's Auditory Performance Scale - Multiple Inputs Subscale Baseline	-1.31 Units on a scale Standard Deviation 0.99	-1.62 Units on a scale Standard Deviation 1.21
Children's Auditory Performance Scale - Multiple Inputs Subscale 3 months	-1.33 Units on a scale Standard Deviation 1.09	-1.21 Units on a scale Standard Deviation 1.00
Children's Auditory Performance Scale - Multiple Inputs Subscale 6 months	-1.05 Units on a scale Standard Deviation 1.14	-1.33 Units on a scale Standard Deviation 1.41

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 6 months

Parental questionnaire measured in raw unstandardised scores. Minimum value is -5, maximum value is +1. Higher score means better outcome.

Outcome measures

Outcome measures
Measure	APD Control Group n=13 Participants Comprised of 13 children diagnosed with APD and does not receive any intervention.	APD Intervention Group n=13 Participants Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
Children's Auditory Performance Scale - Auditory Memory Sequencing Subscale Baseline	-1.77 Units on a scale Standard Deviation 1.15	-2.63 Units on a scale Standard Deviation 1.53
Children's Auditory Performance Scale - Auditory Memory Sequencing Subscale 3 months	-2.24 Units on a scale Standard Deviation 1.30	-2.06 Units on a scale Standard Deviation 1.33
Children's Auditory Performance Scale - Auditory Memory Sequencing Subscale 6 months	-2.14 Units on a scale Standard Deviation 1.35	-2.51 Units on a scale Standard Deviation 1.41

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 6 months

Parental questionnaire measured in raw unstandardised scores. Minimum value is -5, maximum value is +1. Higher score means better outcome.

Outcome measures

Outcome measures
Measure	APD Control Group n=13 Participants Comprised of 13 children diagnosed with APD and does not receive any intervention.	APD Intervention Group n=13 Participants Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
Children's Auditory Performance Scale - Auditory Attention Span Subscale Baseline	-1.34 Units on a scale Standard Deviation 0.86	-1.84 Units on a scale Standard Deviation 1.16
Children's Auditory Performance Scale - Auditory Attention Span Subscale 3 months	-1.62 Units on a scale Standard Deviation 1.06	-1.57 Units on a scale Standard Deviation 0.93
Children's Auditory Performance Scale - Auditory Attention Span Subscale 6 months	-1.46 Units on a scale Standard Deviation 1.04	-1.77 Units on a scale Standard Deviation 1.17

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: One parent from intervention group did not complete any of the questionnaires, hence intervention group number analysed was 12.

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.

Outcome measures

Outcome measures
Measure	APD Control Group n=13 Participants Comprised of 13 children diagnosed with APD and does not receive any intervention.	APD Intervention Group n=12 Participants Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
The Children's Communication Checklist - 2 - Standard Language Composite Score Baseline	5.82 scaled scores Standard Deviation 2.65	5.44 scaled scores Standard Deviation 2.56
The Children's Communication Checklist - 2 - Standard Language Composite Score 3 months	6.03 scaled scores Standard Deviation 2.71	5.39 scaled scores Standard Deviation 2.88
The Children's Communication Checklist - 2 - Standard Language Composite Score 6 months	6.50 scaled scores Standard Deviation 2.84	5.58 scaled scores Standard Deviation 2.35

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 6 months

Population: One parent from intervention group did not complete any of the questionnaires, hence intervention group number analysed was 12.

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.

Outcome measures

Outcome measures
Measure	APD Control Group n=13 Participants Comprised of 13 children diagnosed with APD and does not receive any intervention.	APD Intervention Group n=12 Participants Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
The Children's Communication Checklist - 2 - Non-Standard Language Composite Score Baseline	6.25 scaled scores Standard Deviation 2.82	6.19 scaled scores Standard Deviation 2.66
The Children's Communication Checklist - 2 - Non-Standard Language Composite Score 3 months	6.38 scaled scores Standard Deviation 2.87	6.08 scaled scores Standard Deviation 2.60
The Children's Communication Checklist - 2 - Non-Standard Language Composite Score 6 months	6.61 scaled scores Standard Deviation 3.06	5.70 scaled scores Standard Deviation 2.83

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	APD Control Group Comprised of 13 children diagnosed with APD and does not receive any intervention.	APD Intervention Group n=5 Participants Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
Screening Instrument For Targeting Educational Risk Performance Scale - Attention Subscale Baseline	—	2.33 units on a scale Standard Deviation 0.59
Screening Instrument For Targeting Educational Risk Performance Scale - Attention Subscale 6 months	—	2.79 units on a scale Standard Deviation 1.00

Adverse Events

APD Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

APD Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mr Georgios Stavrinos

UCL Ear Institute

Phone: 07856067517

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place