Hearing Aids for Tinnitus with Hearing Loss (HUSH)
| ISRCTN | ISRCTN14218416 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14218416 |
| Secondary identifying numbers | 38593 |
- Submission date
- 30/07/2018
- Registration date
- 08/08/2018
- Last edited
- 07/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Plain English Summary
Background and study aims
In the UK, about one in ten people experience tinnitus, which is hearing a sound (like a buzzing, ringing or whooshing) without any external source. The sound may be in one or both ears, or in the head. The most common help people get for tinnitus is being given advice about tinnitus and taught strategies to live better with tinnitus. Some patients also have counselling, if needed. This is called standard care because it is the treatment that everyone gets in clinics in the UK because it is known to help. If someone has hearing loss as well as tinnitus, some audiologists might give a hearing aid in addition to standard care to see if it helps the tinnitus. They think the hearing aid could make the sounds people do want to hear louder, making the tinnitus sound quieter over time. However, it is not known whether hearing aids help in this way. A large trial is needed to find out if giving hearing aids in addition to standard care would help improve tinnitus. Before running this large trial the aim of this study is to check that there are enough patients and audiologists interested in taking part.
Who can participate?
Patients aged 18 or over with tinnitus and hearing loss
What does the study involve?
During their first appointment for tinnitus with an audiologist, participants answer questions about their tinnitus and are randomly allocated to either receive standard care, or to receive standard care and also be fitted with a hearing aid. After 12 weeks participants are sent a questionnaire in the mail to see how their tinnitus is. Some participants are also asked to take part in an optional interview to share their experiences of having tinnitus and being in the trial.
What are the possible benefits and risks of participating?
It is not known whether using a hearing aid in addition to other tinnitus management strategies provides any benefit for the treatment of tinnitus above and beyond the benefits of management strategies alone. This study will help to determine whether or not it will be possible to run a larger study to try to answer this question. The information collected in this study will help improve the understanding of what current practice is and the interviews will provide more detailed information on any potential benefits/barriers to this research and to the treatment options available to people with tinnitus. Participants will also be helping to improve the ways in which hearing research studies are run, both now and in the future.
Where is the study run from?
1. Nottingham University Hospitals NHS Trust (UK)
2. Chesterfield Royal Hospital NHS Foundation Trust (UK)
3. Sheffield Teaching Hospitals NHS Foundation Trust (UK)
4. Sherwood Forest Hospitals NHS Foundation Trust (UK)
5. Cardiff & Vale University Health Board (UK)
When is the study starting and how long is it expected to run for?
October 2018 to January 2020
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Garry Meakin
Contact information
Scientific
Nottingham Clinical Trials Unit
School of Medicine
University of Nottingham
Room 2000a, NHSP, C Floor South Block, QMC
Nottingham
NG7 2UH
United Kingdom
 ORCID ID |
0000-0001-8593-3421 |
|---|
Study information
| Study design | Randomised; Interventional; Design type: Treatment, Device |
|---|---|
| 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 the contact details to request a patient information sheet |
| Scientific title | Feasibility of conducting a multi-centre randomised controlled trial to assess effectiveness and cost-effectiveness of digital hearing aids in patients with tinnitus and hearing loss |
| Study acronym | HUSH |
| Study hypothesis | The HUSH trial is a feasibility trial designed to investigate the feasibility and acceptability of conducting a randomised controlled trial (RCT) comparing i) education and advice (Treatment as Usual; TAU) with ii) TAU with digital hearing aids, for management of people with tinnitus and hearing loss. |
| Ethics approval(s) | West Midlands – The Black Country, 06/07/2018, ref: 18/WM/0153 |
| Condition | Tinnitus with hearing loss |
| Intervention | Participants will be randomised in a 1:1 ratio to receive either digital hearing aids plus treatment as usual (intervention group) or treatment as usual alone (control group). Digital hearing aids are fitted in an audiology clinic according to standard clinical procedures. Treatment as usual may consist of any combination of the following: information and education about tinnitus and hearing, the impact of tinnitus and hearing loss on participant’s quality of life and different levels of counselling depending on patient’s need. For the purposes of the trial, TAU must not include the prescription of any combination device or at-ear sound generator, and for the control arm must not include the provision of hearing aids. Trial participation involves 1 to 2 visits with an audiologist, at-home completion of a questionnaire pack at 12 weeks post baseline and the option to participate in a one-off interview which will take place no more than 18 weeks post baseline. PRE-BASELINE Participants receive study invitation letter and participant information sheet in the post along with their tinnitus appointment letter. BASELINE VISIT During the standard care audiology appointment, the audiologist will provide information about the study, consent will be taken and eligibility assessed. Participants have the option to consent to taking part in the study, or only to participating in the patient-interviews. Participants are randomised to receive standard care (take place during the same visit) or standard care plus fitting of a hearing aid. Participants will complete some additional questionnaires during the baseline appointment. All research activities, including the consent process, will take between 30 minutes and 1 hour in addition to standard care. If participants are received to be fitted with a hearing aid, this may be fitted at the same appointment or at a second appointment taking place approximately 2 weeks after the baseline visit. The timepoint of hearing aid fitting will be dependent on local policy. Hearing aid fitting appointments take approximately 30 minutes. TREATMENT PHASE Participants will have a 12-week treatment phase during which they will implement the advice provided to them as a part of standard care and use the hearing aid, if they were randomised to receive one. OUTCOME COLLECTION 12 weeks post-baseline, the participant will receive a questionnaire pack in the mail. The questionnaire pack will be sent from the trial coordinating unit with a pre-paid return envelope. The questionnaire will take approximately 45 minutes to complete. PATIENT AND PARTICIPANT INTERVIEWS If they have consented to being contacted for a participant interview, after return of their 12 week questionnaire they will be contacted by a qualitative researcher to schedule an interview. This may take place over the phone or face to face. The interview will last approximately 1 hour. For patients who did not consent to taking part in the randomised study but did consent to be contacted by a qualitative researcher for an interview, this contact will be made by the qualitative researcher after the clinic visit. The interview may take place over the phone or face to face and will last approximately 1 hour. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Feasibility outcomes for the trial have been defined to determine the feasibility and acceptability of running a future large main trial: 1. Recruitment: Outcomes to assess whether it would be possible to recruit to a definitive trial. This includes proportion of patients eligible for the trial, barriers to screening and recruitment, number and proportion of patients recruited and randomised, characteristics of recruited patients, hearing aid compliance, completeness of the collected data, components of TAU used across sites, re-referral rates. Interviews with recruiting audiologists towards the end of the recruitment period (12 months) 2. Acceptability: Outcomes to assess whether patients and clinicians would find the interventions and trial acceptable. This will include feedback from patients and clinicians regarding experience with the trial (e.g. conduct, design, barriers) and opinions of the intervention, hearing aid use compliance. Actual usage at 12 weeks compared to advised usage at baseline |
| Secondary outcome measures | 1. Assessment: Outcomes to help identify the most appropriate primary outcome for a definitive trial, including patient opinion of relevance of patient reported outcome measures, distribution of patient reported outcome measures at baseline and 12 weeks 2. Safety: Collection of data to capture exacerbation of symptoms at 12 weeks 3. Patient reported outcome measures will inform choice of primary outcome for the main trial: 3.1. Severity of tinnitus, measured using Tinnitus Functional Index (TFI) at baseline and 12 weeks 3.2. Effects of hearing impairment and social adjustment, measured using Hearing Handicap Inventory for the Elderly (HHIE) at baseline and 12 weeks 3.3. General health status, measured using Health Utilities Index Mark 3 (HUI3) at baseline and 12 weeks 3.4. Depression and anxiety, measured using Hospital Anxiety and Depression Scale (HADS) at baseline and 12 weeks 3.5. Symptoms that the participant consider most important, measured using Measures Yourself Medical Outcome Profile (MYMOP) at baseline and 12 weeks 3.6. Health-related quality of life, measured using EQ5D5L at baseline and 12 weeks 3.7. Participant reported improvement in tinnitus and hearing, measured using Global Rating of Change Score at 12 weeks 4. The feasibility of collecting data for a health economic evaluation will be captured through a healthcare resource use questionnaire at 12 weeks |
| Overall study start date | 01/10/2018 |
| Overall study end date | 01/01/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 100; UK Sample Size: 100 |
| Total final enrolment | 83 |
| Participant inclusion criteria | 1. Age 18 or over with a clinical diagnosis of tinnitus with hearing loss, as defined by assessing audiologist 2. Providing written informed consent |
| Participant exclusion criteria | 1. Tinnitus of a medically treatable origin 2. Previous use of a hearing aid in the last 12 months 3. Use of any combination device or behind the ear sound generator 4. Inability to communicate in English 5. Started or stopped medication for anxiety/depression within the last 3 months |
| Recruitment start date | 01/10/2018 |
| Recruitment end date | 30/09/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centres
NG1 5DU
United Kingdom
United Kingdom
S10 2JF
United Kingdom
NG17 4JL
United Kingdom
CF14 4XW
United Kingdom
Sponsor information
Hospital/treatment centre
Queens Medical Centre
Nottingham
NG7 2UH
England
United Kingdom
"ROR" |
https://ror.org/05y3qh794 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/04/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The protocol will be submitted to a peer reviewed journal (e.g. BMC Pilot and Feasibility Studies) prior to completing patient recruitment. Locally, study updates and key findings will be disseminated to a general audience through Nottingham University and Hospital communications teams. Wider networks for disseminating findings to a multi-disciplinary professional audience include the EU TINNET research network (http://tinnet.tinnitusresearch.net/) and a new Innovative Training Network (European School for Interdisciplinary Tinnitus Research). Additional plans: Academic: 1. Manuscripts will be submitted to high impact peer-reviewed journals and will be Open Access. The trial team has an excellent record (>50 tinnitus publications since 2010). The trial will be reported according to Consolidated Standards of Reporting Trials (CONSORT) guidelines 2. Presentations during relevant international (e.g. International Tinnitus Seminars,Tinnitus Research Initiative) and national (e.g. British Tinnitus Association, British Society of Audiology) conferences Clinicians: 1. Research summaries and commentaries to clinical audiences. Presentations during relevant national and international conferences (European Federation of Audiological Societies, British Academy of Audiology, British Society of Audiology, British Tinnitus Association) 2. Key points relevant to UK practice will target professional magazines (e.g. ENT & Audiology News) Members of the public: 1. All trial participants will be provided with copies of study outputs 2. All academic articles will be supplemented with a plain English summary on our website (www.hearing.nihr.ac.uk) 3. Research summaries and commentaries in plain English will be published in the BTA Quiet magazine and/or Action on Hearing Loss online newsletter 4. Study updates in the NIHR BRC’s newsletter circulated to >1600 members interested in hearing |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 27/03/2020 | 02/04/2020 | Yes | No |
| Results article | 03/11/2022 | 07/11/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
07/11/2022: Publication reference added.
02/04/2020: Publication reference added.
20/11/2019: The following changes were made to the trial record:
1. The total final enrolment was added.
2. The intention to publish date was changed from 01/01/2021 to 30/04/2020.
28/03/2019: The condition has been changed from "Specialty: Ear, Nose and Throat, Primary sub-specialty: Otology/Audiology/Audiovestibular Medicine; UKCRC code/ Disease: Ear/ Other disorders of ear" to "Tinnitus with hearing loss" following a request from the NIHR.
