ISRCTN ISRCTN69465849
DOI https://doi.org/10.1186/ISRCTN69465849
Secondary identifying numbers N/A
Submission date
24/11/2012
Registration date
14/01/2013
Last edited
23/05/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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), 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?
Patients with tinnitus aged between 18 and 80

What does the study involve?
Each participant has 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 consists of an 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 a reduction of tinnitus distress and improved hearing. There are no risks to the participants. The proposed treatment is identical to current clinical practice over the past 3 years.

Where is the study run from?
Rotherham Community Health Centre (UK)

When is the study starting and how long is it expected to run for?
January 2013 to September 2013

Who is funding the study?
The study does not require any funding as the participants undergo the same interventions currently carried out in clinic.

Who is the main contact?
Peter Byrom
peter.byrom@rothgen.nhs.uk

Contact information

Dr Nick Thyer
Scientific

School of Healthcare, Faculty of Medicine & Health
Baines Wing
University of Leeds
Leeds
LS2 9UT
United Kingdom

Phone +44 (0)113 343 1238
Email N.J.Thyer@leeds.ac.uk

Study information

Study designSingle-centre quasi-experimental before and after design
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)GP practice
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleDoes amplification alleviate the distress caused by tinnitus in patients with mild hearing loss?
Study objectivesAmplification 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.
Ethics approval(s)Leeds West, 05/03/2013, ref: 13/YH/0033
Health condition(s) or problem(s) studiedTinnitus/mild hearing loss
InterventionBefore 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.
Intervention typeOther
Primary outcome measureTinnitus Functional Index (TFI) before intervention and 6 weeks post intervention
Secondary outcome measuresNo secondary outcome measures
Overall study start date01/01/2013
Completion date01/09/2013

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants40
Key inclusion criteria1. 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
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/01/2013
Date of final enrolment01/09/2013

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Leeds
Leeds
LS2 9UT
United Kingdom

Sponsor information

University of Leeds (UK)
University/education

Faculty Research Ethics and Governance Administrator
Faculty Research Office, Room 10.110, Level 10
Worsley Building
Clarendon Way
Leeds
LS2 9NL
England
United Kingdom

Website http://www.leeds.ac.uk/
ROR logo "ROR" https://ror.org/024mrxd33

Funders

Funder type

Other

Investigator initiated and funded (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPublication plans are unknown at this stage.
IPD sharing planThe current 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?
HRA research summary 28/06/2023 No No

Editorial Notes

12/05/2017: IPD sharing statement added.