Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03904264 |
| Other study ID # |
C3196-P |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 24, 2020 |
| Est. completion date |
September 30, 2022 |
Study information
| Verified date |
November 2023 |
| Source |
VA Office of Research and Development |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Tinnitus - defined as ringing, humming, or other sounds in the ears or head - is a very
common problem for Veterans. Hearing aids that deliver low-level amplification are being used
by audiologists to help people with tinnitus who also have normal hearing. However, there is
a lack of research evidence showing that this practice is effective. Despite this fact, the
practice clearly is spreading. Reports from audiologists in the field as well as research
presentations refer to hearing aids being used in this way. Use of hearing aids has been
shown to reduce distress from tinnitus for people with hearing loss. Additionally, the use of
external sound to help reduce the impact of tinnitus has been shown to be effective. There is
clearly a gap in the research regarding the use of hearing aids as a therapeutic method to
manage tinnitus when hearing is considered normal. This study will obtain pilot data
evaluating people with normal hearing and bothersome tinnitus to find out whether low-level
amplification through hearing aids may provide benefit.
Description:
Tinnitus - defined as ringing, humming, or other sounds in the ears or head - is the most
prevalent service-connected disability among Veterans. Tinnitus affects 10-15% of the adult
population. For about 20% of these, tinnitus impacts their lives with respect to sleep
disturbance, impaired concentration, and/or emotional reactions. These 20% are the most in
need of clinical services. It has been shown that providing amplification via hearing aids
for people with hearing loss can also be beneficial in reducing functional effects of
tinnitus, presumably because amplifying environmental sounds reduces the contrast between the
tinnitus and background sound, allowing the tinnitus to be more easily ignored. There have
been increasing reports from the field of audiologists providing hearing aids set to deliver
low-gain amplification on patients with bothersome tinnitus who are not otherwise hearing aid
candidates, with beneficial outcomes. However, this nontraditional fitting practice has not
been formally evaluated, so there is no research evidence to support the practice. It is
essential for VA to show evidence supporting such practices to justify the use (and expense)
of these devices with patients who otherwise do not qualify to receive hearing aids.
The proposed project is a pilot study that would lay the groundwork for a future full
randomized controlled trial (RCT) evaluating the use of low-gain amplification for bothersome
tinnitus in patients with normal hearing. A pilot sample of 20 Veterans with normal hearing
thresholds and bothersome tinnitus will be fit with mild amplification through
receiver-in-the-canal hearing aids. Hearing aids will be programmed to provide a low-level of
amplification, using NAL-NL2 guidelines for target gain. Outcome measures will be evaluated
pre-fit and post-fit at two follow-up time points (2 weeks and 3 months post-fit). Outcomes
will include the Tinnitus Functional Index (TFI), Hearing Handicap Inventory for Adults
(HHIA) and the Quick Speech in Noise (QuickSIN) test. Outcomes pre and post hearing aid fit
will be compared to evaluate whether the hearing aids provided benefit to participants in
terms of their tinnitus and hearing outcomes. Additionally, participants will be interviewed
at their last visit to find out their self-reported benefit from the hearing aids, as well as
any barriers they encountered to wearing the hearing aids.
Additionally, a group of VA clinical audiologists will be interviewed by telephone. These
clinicians will be identified via an email survey sent to the VA audiologist email group,
asking whether they are providing low-gain amplification for bothersome tinnitus to patients
with normal hearing. The survey will also ask audiologists to volunteer if they are willing
to participate in a brief telephone interview. The aim will be to identify at least ten
audiologists who are fitting hearing aids in this way, and up to five who are not. These
audiologists will be interviewed over the telephone to find out why they have incorporated
this into their clinical practice (or why they have not), and inquire about specific fitting
procedures and criteria for identifying candidates that they have used. These responses will
inform the protocol of the future RCT.
At the conclusion of this project, enough information will be collected to propose a
controlled study of low-gain amplification for bothersome tinnitus in people with normal
hearing. The protocol for that project will be informed by both the successful aspects of the
pilot protocol as well as the input from VA clinicians who are doing this in the field. A
preliminary evaluation of benefit provided by these hearing aids will provide justification
for a large controlled study. Finally, the pilot data will provide the basis for a power
calculation to determine sample size, as well as an estimate of drop-out rate to sufficiently
adjust for attrition. A full RCT demonstrating efficacy of low-gain amplification for
bothersome tinnitus in people with normal hearing would provide needed evidence supporting a
clinical practice that has already gained some traction both within and outside VA. Robust
research evidence is needed to support the continuation and future expansion of this
practice.
