Condition category
Ear, Nose and Throat
Date applied
24/11/2012
Date assigned
14/01/2013
Last edited
24/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 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 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?
The study is run from Rotherham Community Health Centre (UK).

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

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 controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below 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 measures

Tinnitus Functional Index (TFI) before intervention and 6 weeks post intervention.
TFI 100% = tinnitus as severe as it can be
TFI 1% = no tinnitus

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/01/2013

Overall trial end date

01/09/2013

Reason abandoned

Eligibility

Participant 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

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

School of Healthcare, Faculty of Medicine & Health
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

http://www.leeds.ac.uk/

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes