The main objective of the present study is to investigate the optimal stimulation pattern for tinnitus suppression in a structured way. Our study will focus on two parameters: stimulus level and anatomical stimulation site inside the cochlea.
ID
Source
Brief title
Condition
- Inner ear and VIIIth cranial nerve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The study variable is the intensity of the experienced tinnitus. Because
tinnitus is a subjective phenomenon, its intensity is identified by means of
Visual Analogue Scales (VAS).
Secondary outcome
The stimulus intensity is also identified by means of VAS.
Background summary
Tinnitus is a symptom defined as a perceived sound in the absence of an
external source. Its prevalence is reported to be about 10%-15% of the general
population and currently there is no cure for tinnitus. Recent research showed
that changes in neuronal activity might underlie tinnitus pathology. Several
recent studies, which are in general case-reports, show that tinnitus
complaints may be reduced by restoring peripheral auditory neural activity by
means of intracochlear electrical stimulation. However, structured studies to
improve knowledge of the optimal stimulus parameters are limited.
Study objective
The main objective of the present study is to investigate the optimal
stimulation pattern for tinnitus suppression in a structured way. Our study
will focus on two parameters: stimulus level and anatomical stimulation site
inside the cochlea.
Study design
The study consists of two experiments. In each experiment one stimulation
parameter will be investigated using a randomized (controlled) trial. Both
experiments will be repeated with the same subject. So there will be two test
days per subject.
Intervention
Through adjustments in the standard CI settings, the effect of various
stimulation patterns on tinnitus will be investigated. Subjects will be exposed
to external sounds from a mp3-player, which the CI converts to a controlled
electrical stimulation in the cochlea.
Study burden and risks
Prior to the study, participants are asked to fill out two questionnaires (THI
and Tinnitus characteristics) as part of the selection. Furthermore they are
asked to pitch match their tinnitus. During the study, several specific
electrical stimulation patterns will be applied using the patients* CI,
remaining well within its conventional, clinical safety limits. The study
consists of several conditions which take 6 minutes each. During each condition
the subjects are asked to fill out two VAS every 30 seconds. At the end of each
condition the overall stimulus effectiveness will be ranked by means of VAS.
The patient will thus need to invest a few hours (approximately four hours) of
his time, which is weighted against possible scientific study outcome. After
the study the settings will be set back to the settings they had before
participation, or to any setting they wish, in cases of benefit from
testconditions.
The clinical implications are clear. When using a CI to manage tinnitus, the
clinical processor that is optimized for speech perception needs to be
customized for optimal tinnitus suppression.
P. Debyelaan 25
6229 HX Maastricht 6229 HX
NL
P. Debyelaan 25
6229 HX Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
- CI patients (implanted > 3/4 year ago)
- Tinnitus, that is:
o Subjective (idiopathic)
o localized ipsilateral to the CI
o at least mild, that is
- Visual Analogue Scale-score > 3
- Tinnitus Handicap Inventory- score > 16
o Stable tinnitus (stable > 1/2 year)
- Willingness to participate in this research (informed consent)
Exclusion criteria
-objective tinnitus
-age < 18 years old
-Ménière's disease
-active middle ear disease
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL38528.068.12 |
| Other | TC = 3383 |
| OMON | NL-OMON20130 |