Plain English 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), 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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Nick Thyer
ORCID ID
Contact details
School of Healthcare
Faculty of Medicine & Health
Baines Wing
University of Leeds
Leeds
LS2 9UT
United Kingdom
+44 (0)113 343 1238
N.J.Thyer@leeds.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Does amplification alleviate the distress caused by tinnitus in patients with mild hearing loss?
Acronym
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.
Ethics approval
Leeds West, 05/03/2013, ref: 13/YH/0033
Study design
Single-centre quasi-experimental before and after design
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Tinnitus/mild hearing loss
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Tinnitus Functional Index (TFI) before intervention and 6 weeks post intervention
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/01/2013
Overall trial end date
01/09/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/01/2013
Recruitment end date
01/09/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Leeds
Leeds
LS2 9UT
United Kingdom
Sponsor information
Organisation
University of Leeds (UK)
Sponsor details
Faculty Research Ethics and Governance Administrator
Faculty Research Office
Room 10.110
Level 10
Worsley Building
Clarendon Way
Leeds
LS2 9NL
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publication plans are unknown at this stage.
IPD sharing statement
The current data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list