- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03695575
An 'Off-the-shelf' Assistive Listening Device: Normal-hearing Children.
Testing Speech Intelligibility Outcomes With a Commercial Bone-conduction Headset in Children With Normal Hearing.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tamsin M Brown, MBBS, RCPCH
- Phone Number: +441223218072
- Email: tamsin.brown1@nhs.net
Study Contact Backup
- Name: Marina Salorio-Corbetto, PhD
- Phone Number: +447832979916
- Email: marina@chears.co.uk
Study Locations
-
-
Hertsfordshire
-
Shepreth, Hertsfordshire, United Kingdom, SG8 6QS
- Childrens' Hearing Evaluation and Amplification Resource
-
Contact:
- Marina Salorio-Corbetto, PhD
- Phone Number: 1763263333
- Email: marina@chears.co.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
|
A bone-conduction headset paired with a microphone will be used.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Outcomes will be measured in a single session. Four runs are required. The total testing time is around 12 minutes.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Outcomes will be measured in a single session. Four runs are required. The total testing time is around 12 minutes.
|
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.
|
The questionnaire will be completed at the end of the session. Testing time is five minutes.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Tamsin M Brown, MBBS, RCPCH, NHS (National Health Service): Cambridgeshire Community Services (CCS)
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Otorhinolaryngologic Diseases
- Ear Diseases
- Cognition Disorders
- Perceptual Disorders
- Retrocochlear Diseases
- Auditory Diseases, Central
- Auditory Perceptual Disorders
Other Study ID Numbers
- 20180001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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