Investigating the benefit of hearing aids in adults with tinnitus and mild hearing loss
| ISRCTN | ISRCTN31221437 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31221437 |
| IRAS number | 290270 |
| Secondary identifying numbers | IRAS 290270 |
- Submission date
- 16/12/2020
- Registration date
- 02/06/2021
- Last edited
- 21/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Stopped
- Condition category
- Ear, Nose and Throat
Plain English summary of protocol
Background and study aims
The aim of this study is to provide information on whether hearing aids help people with both tinnitus and mild hearing loss to manage their tinnitus more effectively. Hearing loss and tinnitus are very common conditions in the UK, both of which can have significant impact on quality of life and mental health. Current practice by health professionals in the NHS is to offer hearing aid/s to patients with both hearing loss and tinnitus, which is bothersome for them. However, there is no guidance for professionals working with patients with mild hearing loss and tinnitus. This knowledge is important for clinicians to offer the best care to this group of patients. From a public point of view this knowledge will enable them to make the best evidence-based care choices for themselves.
Who can participate?
Patients aged 18 or over with a clinical diagnosis of tinnitus with mild hearing loss in one or both ears
What does the study involve?
Participants will be randomly allocated to have a hearing aid with amplification or without amplification. Participants will not know which hearing aid they receive. Participants will be expected to wear the hearing aid/s every day for a 6-month period. They will be asked to complete four questionnaires at the beginning of the trial, at an 8-week follow up and again at 6 months. Participants will also be asked about hearing aid usage at the 8-week and 6-month follow-up stages.
What are the possible benefits and risks of participating?
By joining in this study participants may see improvements in their tinnitus awareness. The information provided by participants to this study may also help to improve treatment for people with tinnitus and mild hearing loss in the future. As the study is using a low-risk intervention which is routinely offered in the NHS the study team do not anticipate any risks to the participants. Any risk or burden associated with the use of the hearing aid without amplification and/or the possibility of the burden of wearing the hearing aid/s for at least 7 hours will be carried out with the participant’s full and informed consent.
Where is the study run from?
Betsi Cadwaladr University Health Board (UK)
When is the study starting and how long is it expected to run for?
December 2020 to May 2022
Who is funding the study?
Health and Care Research Wales (UK)
Who is the main contact?
Mrs Joanne Goss
joanne.goss@wales.nhs.uk
Contact information
Scientific
Betsi Cadwaladr University Health Board
Audiology Department
Sarn Lane
Bodelwyddan
LL18 5UJ
United Kingdom
 ORCID ID |
0000-0001-9752-9362 |
|---|---|
| Phone | +44 (0)1745 448740 ext 6070 |
| joanne.goss@wales.nhs.uk |
Study information
| Study design | Multicentre interventional double-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN31221437_PIS_v1.1.docx |
| Scientific title | A randomized controlled trial assessing the effectiveness of hearing aids (intervention setting) compared to hearing aids (placebo setting) in reducing tinnitus for adults with mild hearing loss |
| Study acronym | HEaring Aids foR tinnITus and mild hearing loss (HEAR IT) |
| Study objectives | Hearing aids are a management option for alleviating tinnitus symptoms in people who also have a mild hearing loss. |
| Ethics approval(s) | Approved 11/03/2021, North Wales Research Ethics Committee (Central and East) (Wales REC 3, Health and Care Research Support Centre, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, UK; +44 (0)29 2078 5736; Wales.REC3@wales.nhs.uk), REC ref: 21/WA/0038 |
| Health condition(s) or problem(s) studied | Tinnitus and mild hearing loss |
| Intervention | Randomisation treatment allocation will be on a 1:1 basis using a sequentially randomised dynamic adaptive algorithm via a secure database. One group of participants will receive a hearing aid set with amplification (intervention hearing aid/s) and the other group will receive a hearing aid fitted in the same way but without amplification (placebo hearing aid/s). Participants will be expected to wear the hearing aid/s every day for a 6-month period. They will be asked to complete questionnaires, at the beginning of the trial, at an 8-week follow up and again at 6 months. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | The effects of tinnitus measured using the tinnitus functional index (TFI) at baseline, 8 weeks and 6 months post hearing aid fitting |
| Secondary outcome measures | 1. Mental and emotional health disorders screened using the PHQ-9 at baseline, 8 weeks and 6 months post hearing aid fitting 2. Generalised anxiety disorder and severity of anxiety screened using the GAD-7 at baseline, 8 weeks and 6 months post hearing aid fitting 3. General quality of life measured using the ED-5L-3D at baseline, 8 weeks and 6 months post hearing aid fitting 4. Hearing aid usage data collected at 8 weeks and 6 months post hearing aid fitting |
| Overall study start date | 01/12/2020 |
| Completion date | 31/05/2022 |
| Reason abandoned (if study stopped) | Funder closed the trial early |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 128 |
| Total final enrolment | 16 |
| Key inclusion criteria | 1. Age 18 years or over with a clinical diagnosis of tinnitus with mild sensorineural hearing loss* unilaterally or bilaterally, hearing level (4FA) measured no more than 6 months prior to tinnitus assessment appointment 2. Willing to trial hearing aid/s only as a tinnitus management option 3. Capable of providing written informed consent 4. Ability to communicate in English 5. Ability to understand and complete the English versions of the questionnaires *For the purposes of this trial, mild hearing loss is defined as hearing threshold between 26 and 40dBHL when averaged at the four frequencies of 0.5, 1, 2 and 4kHz as per the World Health Organisation definition (2019) and other studies (Donahue et al, 2010; Ferguson et al, 2017; Mathers et al, 2000). This measure is referred to in this protocol as “4FA” |
| Key exclusion criteria | 1. Tinnitus of a medically treatable origin 2. Hearing loss of a medically treatable origin 3. Unilateral tinnitus reported in the ear with normal hearing 4. Hearing loss (4FA) of 41dB or greater unilaterally 5. Those requiring other tinnitus management options 6. Previous use of a hearing aid, combination device or behind the ear sound generator 7. GAD-7 score of 8 or more and/or PHQ-9 score of 10 or more, suggesting more complex mental health needs |
| Date of first enrolment | 19/04/2021 |
| Date of final enrolment | 31/03/2022 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centres
Audiology Department
Sarn Lane
Bodelwyddan
LL18 5UJ
United Kingdom
Audiology Department
Hearing & Balance Unit
Cardiff Road
Newport
NP20 2UB
United Kingdom
Audiology Clinic
Clinic 9, Outpatients Department
Heath Park Way
Cardiff
CF14 4XW
United Kingdom
Sponsor information
Hospital/treatment centre
Research and Development Department
Holywell Community Hospital
Halkyn Road
Bodelwyddan
LL18 5UJ
Wales
United Kingdom
| Phone | +44 (0)3000 856750 |
|---|---|
| lynne.grundy@wales.nhs.uk |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Health & Care Research Wales, Ymchwil Iechyd a Gofal Cymru, Health Care Research Wales, HCRW
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. Participant level data will be shared with the North Wales Organisation for randomised trials in Health for statistical analysis. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v1.1 | 02/06/2021 | No | Yes | |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN31221437_PIS_v1.1.docx
- Uploaded 02/06/2021
Editorial Notes
21/11/2022: The following changes have been made to the study record:
1. The overall trial end date was changed from 30/11/2022 to 31/05/2022 and the plain English summary was updated accordingly.
2. The study has been stopped.
11/04/2022: The final enrolment number has been added.
08/04/2022: The recruitment end date has been changed from 29/04/2022 to 31/03/2022.
14/12/2021: The recruitment end date was changed from 31/12/2021 to 29/04/2022.
02/06/2021: The participant information sheet has been uploaded.
20/01/2021: Trial's existence confirmed by Health and Care Research Wales.
