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

NCT ID: NCT03695575

Last Updated: 2019-01-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-31
• Study Completion Date: 2019-12-31

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.

Conditions

Auditory Processing Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Bone-conduction headset

Intervention Type: DEVICE

A bone-conduction headset paired with a microphone will be used.

Interventions

Bone-conduction headset

A bone-conduction headset paired with a microphone will be used.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Hearing Evaluation and Amplification Resource, Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tamsin M Brown, MBBS, RCPCH

Role: PRINCIPAL_INVESTIGATOR

NHS (National Health Service): Cambridgeshire Community Services (CCS)

Locations

Childrens' Hearing Evaluation and Amplification Resource

Shepreth, Hertsfordshire, United Kingdom

Countries

United Kingdom

Central Contacts

Tamsin M Brown, MBBS, RCPCH

Role: CONTACT

tamsin.brown1@nhs.net

+441223218072

Marina Salorio-Corbetto, PhD

Role: CONTACT

marina@chears.co.uk

+447832979916

Facility Contacts

Marina Salorio-Corbetto, PhD

Role: primary

marina@chears.co.uk

1763263333

Other Identifiers

20180001

Identifier Type: -

Identifier Source: org_study_id