Clinical trial NCT03695575: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Auditory Processing Disorder
Keywords: Bone Conduction
Assistive Listening Devices
Listening Effort
Speech in Noise
Lead sponsor: Children's Hearing Evaluation and Amplification Resource, Ltd.
Sponsor class: OTHER
First posted: 2018-10-04
Enrollment: 24
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mc Cormick Toy Test
timeFrame: Outcomes will be measured in a single session. Four runs are required. The total testing time is around 12 minutes.
Secondary outcomes:
measure: Listening Effort
timeFrame: Outcomes will be measured in a single session. Four runs are required. The total testing time is around 12 minutes.
measure: Wearability Questionnaire
timeFrame: The questionnaire will be completed at the end of the session. Testing time is five minutes.
Other outcomes:
Locations:
city: Shepreth
country: United Kingdom
facility: Childrens' Hearing Evaluation and Amplification Resource
state: Hertsfordshire
Study officials:
affiliation: NHS (National Health Service): Cambridgeshire Community Services (CCS)
name: Tamsin M Brown, MBBS, RCPCH
role: PRINCIPAL_INVESTIGATOR
References: