Efficacy of a combination hearing aid and sound generator
| ISRCTN | ISRCTN15178771 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15178771 |
| IRAS number | 167794 |
| Secondary identifying numbers | IRAS ID: 167794 |
- Submission date
- 16/04/2015
- Registration date
- 27/04/2015
- Last edited
- 12/02/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Plain English summary of protocol
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
Contact information
Public
Hills Rd
Cambridge
CB2 2QQ
United Kingdom
Study information
| Study design | Interventional randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Efficacy of a combination hearing aid and sound generator: a randomised trial |
| Study objectives | 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(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 01/04/2015 |
| Completion date | 31/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80. 40 in test group, 40 in control group. For each centre, 20 will be recruited from each group. |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2015 |
| Date of final enrolment | 01/07/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
- United States of America
Study participating centres
9500 Euclid Avenue, A71
Cleveland, Ohio
44195
United States of America
Cambridge
CB2 0QQ
United Kingdom
Sponsor information
Industry
Kongebakken 9
Smoerum
2765
Denmark
"ROR" |
https://ror.org/05mwsq745 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
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.
