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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03695575
Recruitment Status : Not yet recruiting
First Posted : October 4, 2018
Last Update Posted : January 31, 2019
Information provided by (Responsible Party):
Children's Hearing Evaluation and Amplification Resource, Ltd.

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.

Condition or disease Intervention/treatment Phase
Auditory Processing Disorder Device: Bone-conduction headset Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Testing Speech Intelligibility Outcomes With a Commercial Bone-conduction Headset in Children With Normal Hearing.
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Study sample
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.
Device: Bone-conduction headset
A bone-conduction headset paired with a microphone will be used.

Primary Outcome Measures :
  1. Mc Cormick Toy Test [ Time Frame: Outcomes will be measured in a single session. Four runs are required. The total testing time is around 12 minutes. ]

    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 :
  1. Listening Effort [ Time Frame: Outcomes will be measured in a single session. Four runs are required. The total testing time is around 12 minutes. ]
    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.

  2. Wearability Questionnaire [ Time Frame: The questionnaire will be completed at the end of the session. Testing time is five minutes. ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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 identifier (NCT number): NCT03695575

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Contact: Tamsin M Brown, MBBS, RCPCH +441223218072
Contact: Marina Salorio-Corbetto, PhD +447832979916

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United Kingdom
Childrens' Hearing Evaluation and Amplification Resource Not yet recruiting
Shepreth, Hertsfordshire, United Kingdom, SG8 6QS
Contact: Marina Salorio-Corbetto, PhD    1763263333   
Sponsors and Collaborators
Children's Hearing Evaluation and Amplification Resource, Ltd.
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Principal Investigator: Tamsin M Brown, MBBS, RCPCH NHS (National Health Service): Cambridgeshire Community Services (CCS)

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Responsible Party: Children's Hearing Evaluation and Amplification Resource, Ltd. Identifier: NCT03695575     History of Changes
Other Study ID Numbers: 20180001
First Posted: October 4, 2018    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Children's Hearing Evaluation and Amplification Resource, Ltd.:
Bone Conduction
Assistive Listening Devices
Listening Effort
Speech in Noise

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