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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

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.


Condition or disease Intervention/treatment Phase
Auditory Processing Disorder Device: Remote Microphone Hearing Aids Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Remote Microphone Hearing Aids on Classroom Listening, Spatial Listening, and Attention in School-Aged Children With Auditory Processing Disorder
Actual Study Start Date : May 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hearing Aids

Arm Intervention/treatment
No Intervention: APD Control Group
Comprised 13 children diagnosed with APD and acts as a control without using any form of intervention.
Experimental: APD Intervention Group
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.
Device: Remote Microphone Hearing Aids
The ear receivers connect wirelessly with the microphone being worn by the teacher within a range of 25m.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Secondary Outcome Measures :
  1. Test of Everyday Attention for Children TEACh - Sustained Auditory Attention Subscale [ Time Frame: 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.

  2. Test of Everyday Attention for Children TEACh - Divided Auditory-Visual Attention Subscale [ Time Frame: 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.

  3. Test of Everyday Attention for Children TEACh - Selective Visual Attention Subscale [ Time Frame: 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.

  4. Test of Everyday Attention for Children TEACh - Divided Auditory Attention Subscale [ Time Frame: 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.


Other Outcome Measures:
  1. Children's Auditory Performance Scale - Noise Subscale [ Time Frame: Baseline to 6 months ]
    Parental questionnaire measured in raw unstandardised scores. Minimum value is -5, maximum value is +1. Higher score means better outcome.

  2. Children's Auditory Performance Scale - Multiple Inputs Subscale [ Time Frame: Baseline to 6 months ]
    Parental questionnaire measured in raw unstandardised scores. Minimum value is -5, maximum value is +1. Higher score means better outcome.

  3. Children's Auditory Performance Scale - Auditory Memory Sequencing Subscale [ Time Frame: Baseline to 6 months ]
    Parental questionnaire measured in raw unstandardised scores. Minimum value is -5, maximum value is +1. Higher score means better outcome.

  4. Children's Auditory Performance Scale - Auditory Attention Span Subscale [ Time Frame: Baseline to 6 months ]
    Parental questionnaire measured in raw unstandardised scores. Minimum value is -5, maximum value is +1. Higher score means better outcome.

  5. The Children's Communication Checklist - 2 - Standard Language Composite Score [ Time Frame: 6 months ]
    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.

  6. The Children's Communication Checklist - 2 - Non-Standard Language Composite Score [ Time Frame: Baseline to 6 months ]
    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.

  7. Screening Instrument For Targeting Educational Risk Performance Scale - Attention Subscale [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Normal audiogram.
  2. Diagnosis of APD based on clinical tests administered by qualified audiologists as per the clinic's diagnosis protocol.
  3. No neurological or pervasive disorder or developmental delay (e.g. Attention Deficit Hyperactivity Disorder, epilepsy, Autism Spectrum Disorder, Developmental Language Disorder, Down Syndrome).
  4. Non-verbal cognitive ability score of 85 or greater.
  5. Ages between 7-12 years.
  6. Native English speakers.
  7. No prior use of RMHAs.

Exclusion criteria:

Any violation of the above conditions.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353091


Sponsors and Collaborators
University College, London
GN Resound
Investigators
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Principal Investigator: Doris-Eva Bamiou, MD MSc PhD UCL Ear Institute
  Study Documents (Full-Text)

Documents provided by University College, London:
Informed Consent Form  [PDF] September 29, 2015

Publications:
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02353091    
Other Study ID Numbers: 14/0333
First Posted: February 2, 2015    Key Record Dates
Results First Posted: April 27, 2020
Last Update Posted: May 5, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Auditory Perceptual Disorders
Auditory Diseases, Central
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Cognition Disorders
Neurocognitive Disorders
Mental Disorders