Condition category
Ear, Nose and Throat
Date applied
16/04/2015
Date assigned
27/04/2015
Last edited
12/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Tinnitus is a term used to describe a ‘ringing in the ears’ that comes from inside a person’s body rather than from an outside source. There are various causes of tinnitus, and sometimes there is no identifiable cause. However, tinnitus is often triggered by hearing loss. Using a hearing aid can sometimes help people with tinnitus as it stops their ears straining to hear and helps with their hearing loss. There are also combination hearing aids which provide sound therapy, meaning they can make sounds in the environment louder to distract people from their tinnitus. Some of these combination hearing aids can produce natural sounds, such as rainfall or the ocean, to distract from tinnitus symptoms. In this study, a sound therapy hearing aid will be tested to see whether it works better at providing relief from tinnitus than a standard hearing aid in people with some degree of hearing loss.

Who can participate?
Adults with hearing loss and tinnitus.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (intervention group) receive a sound therapy hearing aid alongside their usual care. Those in group 2 (control group) receive a standard hearing aid alongside their usual care. Participants use their devices for 6 months. Participants are asked to complete various questionnaires and have interviews with the clinician during the study. Follow up interviews take place 1 week after treatment, and again 1, 3 and 6 months later.

What are the possible benefits and risks of participating?
There are no specific risks associated with participating in this study.

Where is the study run from?
1. Cleveland Clinic (USA)
2. Cambridge University Hospitals NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
April 2015 to October 2015

Who is funding the study?
Oticon A/S (Denmark)

Who is the main contact?
Dr D Baguley

Trial website

Contact information

Type

Public

Primary contact

Dr David Baguley

ORCID ID

Contact details

Hills Rd
Cambridge
CB2 2QQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IRAS ID: 167794

Study information

Scientific title

Efficacy of a combination hearing aid and sound generator: a randomised trial

Acronym

Study hypothesis

The benefits of a device with combined hearing aid/sound generator functions are above that of a hearing aid alone, for adults with troublesome tinnitus. Furthermore, the device has good clinical efficacy and is easy for patients and clinicians to use.

Ethics approval

Not provided at time of registration.

Study design

Interventional randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Tinnitus

Intervention

Participants are randomised to one of two groups.

Intervention group: participants will trial a hearing device with built-in tinnitus sound generator feature activated for six months at home, alongside standard care. Participants also receive guidance on use of the device.

Control group: participants will trial a conventional hearing device for six months at home, alongside standard care.

Intervention type

Device

Phase

Drug names

Primary outcome measures

1. Tinnitus Functional Index (TFI) to measure tinnitus severity
2. Tinnitus Acceptance Questionnaire (TAQ)

Secondary outcome measures

1. My Tinnitus document (self-report of symptoms)
2. Hearing Handicap Inventory (HHIA/HHIE) self-report measure of hearing-related disability
3. Patient interviews at each visit

Overall trial start date

01/04/2015

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Hearing impaired with flat or mild to moderate-severe sloping sensorineural hearing loss (SNHL). Hearing loss can be asymmetrical provided participant has been medically cleared for red flag conditions by a physician or otolaryngologist.
2. No limitation on type of fitting that can be worn (e.g. open fitting, closed dome, ear mold allowed, depending on HL).
3. New hearing instrument users preferred to eliminate pre-user bias.
4. GAD-7 anxiety screening: score from 0-9, indicating no anxiety or minimal to mild anxiety only.
5. PHQ-9 depression screening: score from 0-9, indicating no depression or minimal to mild depression only.
6. TFI questionnaire: tinnitus symptoms ranging in severity rating from ≥32 to ≤71 points.
7. Age 18 and over
8. Only mild hyperacusis symptoms

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80. 40 in test group, 40 in control group. For each centre, 20 will be recruited from each group.

Participant exclusion criteria

1. Clinical diagnosis of moderate to severe depression (score ≥10 in PHQ-9 screening)
2. Clinical diagnosis of moderate to severe anxiety disorder (score ≥10 in GAD-7 screening)
3. Patients with severe to profound hearing loss
4. Normal hearing tinnitus patients
5. Patients with very mild or severe to profound tinnitus symptoms
6. Patient where main symptom is hyperacusis
7. Patient cannot hear the sound generator signal at 82 dB(A)SPL

Recruitment start date

01/04/2015

Recruitment end date

01/07/2016

Locations

Countries of recruitment

United Kingdom, United States of America

Trial participating centre

Cleveland Clinic
Head & Neck Institute 9500 Euclid Avenue, A71
Cleveland, Ohio
44195
United States of America

Trial participating centre

Cambridge University Hospitals NHS Foundation Trust
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

Oticon A/S

Sponsor details

Kongebakken 9
Smoerum
2765
Denmark

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Oticon A/S (Denmark)

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

12/02/2016: The overall trial end date has been updated from 01/10/2015 to 31/12/2016, and the recruitment end date has been updated from 01/06/2015 to 01/07/2016.