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An 'Off-the-shelf' Assistive Listening Device: Normal-hearing Children.

Primary Purpose

Auditory Processing Disorder

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Bone-conduction headset
Sponsored by
Children's Hearing Evaluation and Amplification Resource, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Auditory Processing Disorder focused on measuring Bone Conduction, Assistive Listening Devices, Listening Effort, Speech in Noise

Eligibility Criteria

6 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Children aged 6 to 11 years old.
  2. No developmental concerns
  3. No concerns about hearing loss.
  4. No concerns about language development.
  5. English dominant language.

Exclusion Criteria:

  1. History, risk, or parent/carer/teacher concern of hearing loss.
  2. Developmental concerns
  3. Suspected language disability.
  4. Non-English dominant language.

Sites / Locations

  • Childrens' Hearing Evaluation and Amplification Resource

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Study sample

Arm Description

A repeated-measures model will be used. This means that participants in a single arm will be tested in all conditions. Speech recognition and listening effort outcomes will be measured in two conditions: with and without a bone-conduction headset.

Outcomes

Primary Outcome Measures

Mc Cormick Toy Test
The main outcome measure will be an age-appropriate speech test. This test is called "McCormick Toy Test" and it consists in measuring the level needed for the child to identify 71% the words in a closed-set list. A minimum of three reversals is needed to determine the outcome. The outcome is the level of speech in dB (A). Lower levels indicate better performance. The test will be performed in quiet and in noise, with and without the headset. The statistical analysis will depend on the characteristics of the data. Because the data are discrete, performing Analysis of Variance (ANOVA) will not be possible. Comparisons of thresholds obtained in different conditions will be done using non-parametric tests.

Secondary Outcome Measures

Listening Effort
A dual task listening effort measure where the children are asked to pay attention to a screen and follow a simple instruction (press a button if they see a given shape and colour) while they also have to repeat words presented to them via loudspeakers. This paradigm has been used with children before. The listening effort outcomes are measured in terms of reaction time. A shorter reaction time indicates less effort. Differences in reaction time across conditions (without headset vs with headset) will be assessed performing ANOVA tests.
Wearability Questionnaire
A short non-standardized questionnaire about acceptability of the device. The outcomes of the questionnaire will be qualitative data in order to detect patterns in the responses (i.e. dislike of the device, willingness to wear it publicly, etc.) and any patterns detected will be reported.

Full Information

First Posted
September 25, 2018
Last Updated
January 30, 2019
Sponsor
Children's Hearing Evaluation and Amplification Resource, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03695575
Brief Title
An 'Off-the-shelf' Assistive Listening Device: Normal-hearing Children.
Official Title
Testing Speech Intelligibility Outcomes With a Commercial Bone-conduction Headset in Children With Normal Hearing.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 2019 (Anticipated)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hearing Evaluation and Amplification Resource, Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The cochlea, the sensory organ of hearing, is a structure of the temporal bone on the skull. In everyday life sounds are heard via air conduction. This means that vibrations in the air are conducted through our ear canals, via the eardrum and the middle-ear bones, to the cochlea. However, vibrations can be conducted to the cochlea via the bones of the head. Bone-conduction headsets have become popular for recreational use (for example cyclists and runners wear them to listen to music while exercising). When in a noisy environment, if a speech signal is delivered to a microphone connected via Bluetooth to the bone conduction headset, the person wearing the headset receives the speech signal as if the talker were closer to them. The ratio between the speech level and the noise level (SNR, signal-to-noise ratio) is increased, so that it is easier to understand the spoken message. A previous study carried out by the investigators has shown that this may help children with hearing loss due to otitis media with effusion ('glue ear'). The aim of the current study is to explore the potential of the headset to help children with auditory processing disorder (APD). Typically, children with APD have normal audiograms, but, in spite of this, they struggle to understand speech in a background noise. The headset can deliver the speech message to them. Currently, FM systems are used for children with APD in the classroom. These systems are effective, but their cost is high and provision may be limited. The feasibility of the use of the headset in a group of children with normal audiometric thresholds will be assessed. The study hypothesis is that using a bone-conduction headband improves speech recognition in noise and decreases listening effort even when air-conduction hearing thresholds are normal. Measures of speech recognition and listening effort will be done in quiet and in noise with and without the bone-conduction headset in order to measure the effect of using the headset on speech recognition when hearing thresholds are normal.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Auditory Processing Disorder
Keywords
Bone Conduction, Assistive Listening Devices, Listening Effort, Speech in Noise

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study sample
Arm Type
Other
Arm Description
A repeated-measures model will be used. This means that participants in a single arm will be tested in all conditions. Speech recognition and listening effort outcomes will be measured in two conditions: with and without a bone-conduction headset.
Intervention Type
Device
Intervention Name(s)
Bone-conduction headset
Intervention Description
A bone-conduction headset paired with a microphone will be used.
Primary Outcome Measure Information:
Title
Mc Cormick Toy Test
Description
The main outcome measure will be an age-appropriate speech test. This test is called "McCormick Toy Test" and it consists in measuring the level needed for the child to identify 71% the words in a closed-set list. A minimum of three reversals is needed to determine the outcome. The outcome is the level of speech in dB (A). Lower levels indicate better performance. The test will be performed in quiet and in noise, with and without the headset. The statistical analysis will depend on the characteristics of the data. Because the data are discrete, performing Analysis of Variance (ANOVA) will not be possible. Comparisons of thresholds obtained in different conditions will be done using non-parametric tests.
Time Frame
Outcomes will be measured in a single session. Four runs are required. The total testing time is around 12 minutes.
Secondary Outcome Measure Information:
Title
Listening Effort
Description
A dual task listening effort measure where the children are asked to pay attention to a screen and follow a simple instruction (press a button if they see a given shape and colour) while they also have to repeat words presented to them via loudspeakers. This paradigm has been used with children before. The listening effort outcomes are measured in terms of reaction time. A shorter reaction time indicates less effort. Differences in reaction time across conditions (without headset vs with headset) will be assessed performing ANOVA tests.
Time Frame
Outcomes will be measured in a single session. Four runs are required. The total testing time is around 12 minutes.
Title
Wearability Questionnaire
Description
A short non-standardized questionnaire about acceptability of the device. The outcomes of the questionnaire will be qualitative data in order to detect patterns in the responses (i.e. dislike of the device, willingness to wear it publicly, etc.) and any patterns detected will be reported.
Time Frame
The questionnaire will be completed at the end of the session. Testing time is five minutes.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children aged 6 to 11 years old. No developmental concerns No concerns about hearing loss. No concerns about language development. English dominant language. Exclusion Criteria: History, risk, or parent/carer/teacher concern of hearing loss. Developmental concerns Suspected language disability. Non-English dominant language.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tamsin M Brown, MBBS, RCPCH
Phone
+441223218072
Email
tamsin.brown1@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Marina Salorio-Corbetto, PhD
Phone
+447832979916
Email
marina@chears.co.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamsin M Brown, MBBS, RCPCH
Organizational Affiliation
NHS (National Health Service): Cambridgeshire Community Services (CCS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Childrens' Hearing Evaluation and Amplification Resource
City
Shepreth
State/Province
Hertsfordshire
ZIP/Postal Code
SG8 6QS
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marina Salorio-Corbetto, PhD
Phone
1763263333
Email
marina@chears.co.uk

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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An 'Off-the-shelf' Assistive Listening Device: Normal-hearing Children.

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