An 'Off-the-shelf' Assistive Listening Device: Normal-hearing Children.
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|ClinicalTrials.gov Identifier: NCT03695575|
Recruitment Status : Not yet recruiting
First Posted : October 4, 2018
Last Update Posted : January 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Auditory Processing Disorder||Device: Bone-conduction headset||Not Applicable|
|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|
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.
- 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.
- 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.
- 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.
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): NCT03695575
|Contact: Tamsin M Brown, MBBS, RCPCHemail@example.com|
|Contact: Marina Salorio-Corbetto, PhDfirstname.lastname@example.org|
|Childrens' Hearing Evaluation and Amplification Resource||Not yet recruiting|
|Shepreth, Hertsfordshire, United Kingdom, SG8 6QS|
|Contact: Marina Salorio-Corbetto, PhD 1763263333 email@example.com|
|Principal Investigator:||Tamsin M Brown, MBBS, RCPCH||NHS (National Health Service): Cambridgeshire Community Services (CCS)|