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listener is unable to understand conversations in everyday listening environments they risk becoming socially withdrawn and isolated.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 measure
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 (if study stopped)
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
Basic results (scientific)
Publication list