Condition category
Ear, Nose and Throat
Date applied
08/01/2018
Date assigned
23/02/2018
Last edited
23/02/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
One of the main challenges faced by people with hearing loss is understanding speech in noisy environments. Hearing aids can be of some benefit in these situations, but in isolation they are unable to fully overcome the problem. If the hearing-impaired listener is unable to understand conversations in everyday listening environments they risk becoming socially withdrawn and isolated. Auditory training involves structured practice listening to a variety of stimuli and is gaining support as an alternative to hearing aids or a supplementary intervention. Many of the auditory training programs currently available are administered using a computer which may not be appropriate for many older hearing-impaired adults who do not have access to computers. There is therefore a need to develop a non-computerised auditory training intervention which can be delivered easily in the person's home. The aim of this study is to find out whether a new auditory training program, which involves having conversations in the presence of a competing speaker, improves speech perception in everyday challenging listening environments.

Who can participate?
Experienced adult hearing aid users

What does the study involve?
Participants complete a speech and cognition assessment and then undertake a four-week training program at home. They are randomly allocated to one of two training programs using a CD containing either silence (Group 1) or a person speaking (Group 2). Participants are required to play this CD while having a conversation with their communication partner. Each session lasts for 30 minutes and participants are asked to complete this five times per week for four weeks. Their speech in noise performance and cognitive abilities are then evaluated again.

What are the possible benefits and risks of participating?
By taking part in the study participants may see an improvement in their understanding of speech in challenging listening environments. There are no significant risks to taking part as noise levels should not exceed maximum daily noise exposure limits.

Where is the study run from?
Betsi Cadwaldr University Health Board (UK)

When is the study starting and how long is it expected to run for?
November 2012 to October 2018

Who is funding the study?
British Society of Audiology (UK)

Who is the main contact?
Stephanie Greer
Stephanie.Greer@wales.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Miss Stephanie Greer

ORCID ID

Contact details

Wrexham Maelor Hospital
Croesnewydd Road
Wrexham
LL13 7TD
United Kingdom
+44 (0)1978 725685
Stephanie.Greer@wales.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

130980

Study information

Scientific title

Evaluation of live voice auditory training in a randomised controlled trial of existing hearing aid users

Acronym

Live Voice Auditory Training RCT 1.1

Study hypothesis

The primary aim of this study is to explore whether novel auditory training intervention can improve speech intelligibility in noise for experienced hearing aid users. The primary research question is: Does repeated practice improve speech perception in everyday challenging listening environments for experienced adult hearing aid users?

Ethics approval

North Wales REC (Central & East), 27/03/2014, ref: 14/WA/0089

Study design

Single-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Hearing loss

Intervention

Participants are randomised to either experimental or control groups based on a dynamic adaptive allocation algorithm using stratification variables of age (less than 75 years: 75 years or older) and sex (Male:Female).

Allocation to one of two training programs: a CD containing either silence (Group 1) or a person speaking (Group 2). Participants are required to play this CD while having a conversation with their communication partner. Each session lasts for 30 minutes and participants are asked to complete this five times per week for four weeks.

Participants complete a baseline speech and cognition assessment and then after their four week training program their speech in noise performance and cognitive abilities are evaluated again.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Speech in noise performance, measured using the signal to noise ratio loss on QuickSIN at baseline and after training has been completed

Secondary outcome measures

1. Subjective handicap assessed by Total, Social and Emotional scores from the Hearing Handicap Inventory for the Elderly Questionnaire and Glasgow disability measured at baseline and after training has been completed
2. Signal to noise threshold on the Modified Co-ordinate Response Measure measured at baseline and after training has been completed
3. Scores for words and numbers on the Dual Task of Listening and Memory measures, measured at baseline and after training has been completed

Overall trial start date

04/11/2012

Overall trial end date

30/10/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Current hearing aid user
2. Four-frequency average hearing thresholds greater than 20dB HL
3. Need in their personal plan relating to improving speech-in-noise intelligibility
4. Regular communication partner who is willing to complete the training program with them
5. Fluent and comfortable conversing in English
6. No significant self-reported memory or neurological problems
7. Not colour blind

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Average hearing threshold within normal limits
2. No reported difficulties understanding speech in noise
3. Unable to complete a training program at home
4. Unable to attend Wrexham Audiology Service for required research appointments
5. Diagnosed or self reported memory or neurological problems
6. Unable to comfortably converse in English
7. Colour-blind

Recruitment start date

01/04/2014

Recruitment end date

30/04/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Betsi Cadwaldr University Health Board
Wrexham Maelor Hospital Croesnewydd Road
Wrexham
LL13 7TD
United Kingdom

Sponsor information

Organisation

Betsi Cadwaladr University Health Board

Sponsor details

Research and Development Department
Holywell Community Hospital
Halkyn Road
Holywell
CH8 7TZ
United Kingdom
+44 (0)1352 718382
Debra.Slater@wales.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

British Society of Audiology

Alternative name(s)

BSA

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Article in Audacity (British Society of Audiology magazine)

IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available. Patient identifiable information will be stored for 3-6 months and anonymised data will be stored for 5 years after the trial end date on a password protected departmental server.

Intention to publish date

30/10/2019

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes