Auditory Processing DisorderNCT03695575
An 'Off-the-shelf' Assistive Listening Device: Normal-hearing Children.
A study testing Bone-conduction headset in people with Auditory Processing Disorder, run by Children's Hearing Evaluation and Amplification Resource, Ltd. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Auditory Processing Disorder
- What is being tested?
- Bone-conduction headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2019to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6 to 11 years old.
- No developmental concerns
- No concerns about hearing loss.
- No concerns about language development.
- English dominant language.
Who cannot join
- History, risk, or parent/carer/teacher concern of hearing loss.
- Developmental concerns
- Suspected language disability.
- Non-English dominant language.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Childrens' Hearing Evaluation and Amplification Resource
Shepreth, Hertsfordshire, SG8 6QS
Marina Salorio-Corbetto, PhD, 1763263333, marina@chears.co.uk
About this study
Official title: Testing Speech Intelligibility Outcomes With a Commercial Bone-conduction Headset in Children With Normal Hearing.
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.
- Conditions
- Auditory Processing Disorder
- Being tested
- Bone-conduction headset
- Keywords
- Bone Conduction, Assistive Listening Devices, Listening Effort, Speech in Noise
- Medical subject headings
- Auditory Perceptual Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone-conduction headsetDevice
A bone-conduction headset paired with a microphone will be used.
| Study group | Role | What they receive |
|---|---|---|
| Study sample | Other | 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. Receives: Device: Bone-conduction headset |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Outcomes will be measured in a single session. Four runs are required. The total testing time is around 12 minutes.
Secondary outcomes (2)
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.
Measured: Outcomes will be measured in a single session. Four runs are required. The total testing time is around 12 minutes.
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.
Measured: The questionnaire will be completed at the end of the session. Testing time is five minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study startMar 2019 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auditory Processing DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hearing Evaluation and Amplification Resource, Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tamsin M Brown, MBBS, RCPCH, Principal investigator, NHS (National Health Service): Cambridgeshire Community Services (CCS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695575
- Sponsor's protocol ID
- 20180001
- Status last verified
- Jan 2019
- First submitted
- 25 Sep 2018
- Last updated
- 31 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Speech Intelligibility Outcomes With a Commercial Bone-conduction Headset in Children With Normal Hearing.
- ClinicalTrials.gov ID
- NCT03695575
- Acronym / sponsor ID
- 20180001
- Conditions
- Auditory Processing Disorder
- Keywords
- Bone Conduction, Assistive Listening Devices, Listening Effort, Speech in Noise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Children's Hearing Evaluation and Amplification Resource, Ltd.University, hospital or other
- Study start
- Mar 2019 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 4 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study sample | Other | Device: Bone-conduction headsetA 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. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 6 to 11 years old.
- No developmental concerns
- No concerns about hearing loss.
- No concerns about language development.
- English dominant language.
Key exclusion criteria (4 listed)
- History, risk, or parent/carer/teacher concern of hearing loss.
- Developmental concerns
- Suspected language disability.
- Non-English dominant language.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone-conduction headsetA bone-conduction headset paired with a microphone will be used. | Device | Study sample |
Primary outcome
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.
2 secondary outcomes
Listening Effort
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamsin M Brown, MBBS, RCPCH principal investigator
NHS (National Health Service): Cambridgeshire Community Services (CCS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone-conduction headset in people with Auditory Processing Disorder, run by Children's Hearing Evaluation and Amplification Resource, Ltd. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tamsin M Brown, MBBS, RCPCH (+441223218072, tamsin.brown1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019.