Live Voice Auditory Training RCT 1.1
| ISRCTN | ISRCTN31892374 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31892374 |
| Secondary identifying numbers | 130980 |
- Submission date
- 08/01/2018
- Registration date
- 23/02/2018
- Last edited
- 14/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Plain English summary of protocol
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listener is unable to understand conversations in everyday listening environments they risk becoming socially withdrawn and isolated.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 June 2019 (as of 18/10/2018)
Who is funding the study?
British Society of Audiology (UK)
Who is the main contact?
Stephanie Greer
Stephanie.Greer@wales.nhs.uk
Contact information
Principal Investigator
Wrexham Maelor Hospital
Croesnewydd Road
Wrexham
LL13 7TD
United Kingdom
 ORCID ID |
0000-0002-4451-8296 |
|---|---|
| Phone | +44 (0)3000 850078 |
| stephanie.lowe@wales.nhs.uk |
Study information
| Study design | Single-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Evaluation of live voice auditory training in a randomised controlled trial of existing hearing aid users |
| Study acronym | Live Voice Auditory Training RCT 1.1 |
| Study objectives | 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(s) | North Wales REC (Central & East), 27/03/2014, ref: 14/WA/0089 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 04/11/2012 |
| Completion date | 30/06/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 50 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2014 |
| Date of final enrolment | 30/11/2018 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Croesnewydd Road
Wrexham
LL13 7TD
United Kingdom
Sponsor information
Hospital/treatment centre
Research and Development Department
Holywell Community Hospital
Halkyn Road
Holywell
CH8 7TZ
Wales
United Kingdom
| Phone | +44 (0)1352 718382 |
|---|---|
| Debra.Slater@wales.nhs.uk | |
"ROR" |
https://ror.org/03awsb125 |
Funders
Funder type
Other
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- BSA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/06/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Article in Audacity (British Society of Audiology magazine) |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 19/02/2022 | 30/09/2022 | Yes | No | |
| Protocol file | version 1.3 | 18/03/2014 | 14/10/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
14/10/2022: Protocol uploaded (not peer reviewed).
04/10/2022: Contact details updated, total final enrolment added.
30/09/2022: Publication reference added.
18/10/2018: The following changes have been made to the trial record:
1. The overall trial end date has been changed from 30/10/2018 to 30/06/2019
2. The recruitment end date has been changed from 30/04/2018 to 30/11/2018
3. The plain English summary has been updated with the new trial end date
4. The intention to publish date has been changed from 30/10/2019 to 30/06/2020
