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

C

Children's Hearing Evaluation and Amplification Resource, Ltd.

Status

Unknown

Conditions

Auditory Processing Disorder

Treatments

Device: Bone-conduction headset

Study type

Interventional

Funder types

Other

Identifiers

NCT03695575
20180001

Details and patient eligibility

About

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.

Enrollment

24 estimated patients

Sex

All

Ages

6 to 11 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

24 participants in 1 patient group

Study sample
Other group
Description:
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.
Treatment:
Device: Bone-conduction headset

Trial contacts and locations

1

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Central trial contact

Tamsin M Brown, MBBS, RCPCH; Marina Salorio-Corbetto, PhD

Data sourced from clinicaltrials.gov

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