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
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
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