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

NCT02353091 | Completed Results

• 1 other identifier: 14/0333
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Auditory Processing Disorder

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  Baseline to 6 months

Secondary Outcomes (4)

• Test of Everyday Attention for Children TEACh - Sustained Auditory Attention Subscale

  Baseline to 6 months

• Test of Everyday Attention for Children TEACh - Divided Auditory-Visual Attention Subscale

  Baseline to 6 months

• Test of Everyday Attention for Children TEACh - Selective Visual Attention Subscale

  Baseline to 6 months

• Test of Everyday Attention for Children TEACh - Divided Auditory Attention Subscale

  Baseline to 6 months

Other Outcomes (7)

• Children's Auditory Performance Scale - Noise Subscale

  Baseline to 6 months

• Children's Auditory Performance Scale - Multiple Inputs Subscale

  Baseline to 6 months

• Children's Auditory Performance Scale - Auditory Memory Sequencing Subscale

  Baseline to 6 months

Study Arms (2)

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.

Device: Remote Microphone Hearing Aids

Interventions

Remote Microphone Hearing Aids DEVICE

The ear receivers connect wirelessly with the microphone being worn by the teacher within a range of 25m.

APD Intervention Group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Any violation of the above conditions.

Sponsors & Collaborators

• University College, London: lead
• GN Resound: collaborator

Related Publications (7)

• 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.

  PMID: 19925352 BACKGROUND

• 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.

  PMID: 21599614 BACKGROUND

• 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.

  PMID: 25153108 BACKGROUND

• 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.

  PMID: 24370466 BACKGROUND

• 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.

  PMID: 19925345 BACKGROUND

• 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.

  PMID: 29988006 BACKGROUND

• 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.

  PMID: 32973443 DERIVED

MeSH Terms

Conditions

Auditory Perceptual Disorders

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

Placebo, Hawthorne or observer bias effects may have influenced the results.

Results Point of Contact

• Title: Mr Georgios Stavrinos
• Organization: UCL Ear Institute

georgios.stavrinos.13@ucl.ac.uk

07856067517

Study Officials

• Doris-Eva Bamiou, MD MSc PhD

  UCL Ear Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: February 2, 2015
• Study Start: May 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: May 5, 2020
• Results First Posted: April 27, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share