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21 March 2013
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| [ Print-friendly version ] |
| Hearing aids, mild hearing loss and tinnitus |
| ISRCTN | ISRCTN69465849 |
| DOI | 10.1186/ISRCTN69465849 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Hearing aids, mild hearing loss and tinnitus |
| Scientific title | Does amplification alleviate the distress caused by tinnitus in patients with mild hearing loss? |
| Acronym | N/A |
| Serial number at source | N/A |
| Study hypothesis | Amplification provided by digital hearing instruments using open fit technology combined with counselling, giving advice and information alleviates the Tinnitus distress measured by the Tinnitus Mini Questionnaire in patients with a mild hearing loss. |
| Lay summary |
Background and study aims
Hearing aid technology has changed dramatically over the last decade, with the use of miniaturised computer chips and improved plastics engineering. Both the structural design and the sound processing have seen major changes. It is suggested that the rules previously used to guide the selection of hearing aids for hearing losses, and the minimum hearing loss are not relevant when considering the modern hearing instrument.In particular, for those patients with a mild hearing loss, and also suffering from Tinnitus (the perception of noise in one ear, both ears or the head. The noise comes from inside the body rather than an outside source), new open fit digital hearing aids are thought to be helpful with mild hearing losses where traditional hearing aids would not have been fitted. The aim of this study is to inform the clinical practice of audiologists who see patients with distressing Tinnitus associated with a mild hearing loss; in particular whether these patients should be offered amplification with digital hearing instruments using open fit technology. A secondary aim would be to stimulate further research on a larger scale possibly using multiple centres. A larger scale, longer term and more robust study with higher numbers of patients involved would serve to support the findings of this smaller study. Who can participate? Eligible participants both male and female aged between 18 and 80 years, referred to Audiology for Tinnitus management by GP, Audiologist , or ENT, a Tinnitus Functional Index Score higher than 24, any Hearing Threshold >20dB in either ear, psychosocially, mentally, and physically able to fully comply with the protocol including adhering to follow up schedules and requirements and filling out forms. What does the study involve? Each participant will have their tinnitus severity measured before treatment and six weeks after treatment to measure any changes. The measurement tool to be used is the Tinnitus Functional Index which is sensitive to change over time. Treatment will consist of open-fit hearing aid fitting verified by Real Ear Measurement. What are the possible benefits and risks of participating? The possible benefits of participating are an reduction of tinnitus distress and a improved hearing. There are no risks to the participants. The proposed intervention (treatment) is identical to current clinical practice over the past 3 years. Where is the study run from? The study is run from The Audiology Department, Rotherham Community Health Centre, Greasbrough Road, Rotherham S60 1RY. When is the study starting and how long is it expected to run for? The study is due to start in Janury 2013 and finish in September 2013 Who is funding the study? The study does not require any funding as the participants will be undergoing the same interventions currently carried out in clinic. Who is the main contact? Peter Byrom peter.byrom@rothgen.nhs.uk |
| Ethics approval | Yorkshire and Humber REC - approval pending |
| Study design | Single centre quasi-experimental before and after design |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Tinnitus / Mild Hearing Loss |
| Participants - inclusion criteria |
Eligible patients must fulfill the following criteria:
1. Referred to Audiology for Tinnitus management by general practitioner (GP), Audiologist or ENT 2. A Tinnitus Functional Index higher than 24 3. Any Hearing Threshold >20dB in either ear 4. Aged between 18 and 80 years, either sex 5. Voluntary informed consent given 6. Psychosocially, mentally, and physically able to fully comply with the protocol including adhering to follow up schedules and requirements and filling out forms |
| Participants - exclusion criteria | Does not meet inclusion criteria |
| Anticipated start date | 01/01/2013 |
| Anticipated end date | 01/09/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 40 |
| Interventions |
Before and after - no control
Prior to treatment, the Tinnitus Functional Index (TFI) is completed by each participant. They are then fitted with "open-fit" hearing aids using real ear measurements as a verification to National Acoustic Laboratories - Non Linear 2 (NAL-NL2) algorithm. After 6 weeks the TFI is completed again to measure relief from Tinnitus provided by the hearing aids. |
| Primary outcome measure(s) |
Tinnitus Functional Index (TFI) before intervention and 6 weeks post intervention.
TFI 100% = tinnitus as severe as it can be TFI 1% = No tinnitus severity |
| Secondary outcome measure(s) | No secondary outcome measures |
| Sources of funding | Investigator initiated and funded (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr Nick Thyer |
| Address |
School of Healthcare, Faculty of Medicine & Health
Baines Wing University of Leeds |
| City/town | Leeds |
| Zip/Postcode | LS2 9UT |
| Country | United Kingdom |
| Tel | +44 (0)113 343 1238 |
| N.J.Thyer@leeds.ac.uk | |
| Sponsor | University of Leeds (UK) |
| Address |
Faculty Research Ethics and Governance Administrator
Faculty Research Office, Room 10.110, Level 10 Worsley Building Clarendon Way |
| City/town | Leeds |
| Zip/Postcode | LS2 9NL |
| Country | United Kingdom |
| Sponsor website: | http://www.leeds.ac.uk/ |
| Date applied | 24/11/2012 |
| Last edited | 14/01/2013 |
| Date ISRCTN assigned | 14/01/2013 |
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| © 2013 ISRCTN unless otherwise stated. | |
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