To test the hypothesis, which states that gap detection is impaired in tinnitus.
ID
Source
Brief title
Condition
- Hearing disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The gap detection test results in a minimum audible gap that a subject can
hear. This minimum audible gap is referred to as the gap detection threshold.
The main study outcome is the difference between the gap detection thresholds
of both subject groups.
Secondary outcome
A secondary hypothesis is that gap detection in humans is more impaired at
sound frequencies close to the tinnitus frequency as compared to frequencies
that are further away. The relation between gap detection impairment and the
tinnitus frequency is a secondary outcome of this study.
Background summary
Tinnitus is a phantom sound percept. Subjects with tinnitus continuously hear a
sound that is not related to an acoustical source. Animal models of tinnitus
have suggested that tinnitus is associated with impaired gap detection. It is
unknown whether humans with tinnitus have impaired gap detection. The
hypothesis of this research is that human subjects with tinnitus will show
impaired performance on a gap detection test. A gap detection test is a hearing
test in which subjects have to identify brief gaps (pauses) in auditory
stimuli. The ability to hear the silent pause is hypothesized to be impaired in
tinnitus subjects. If the hypothesis is true, this research will provide an
important validation of the relevance of animal models of tinnitus to humans.
In addition, then the gap detection test may be a possible diagnostic test for
tinnitus.
Study objective
To test the hypothesis, which states that gap detection is impaired in
tinnitus.
Study design
Three groups of subjects will be included. The first group hears tinnitus. The
second group hears no tinnitus. This is a control group that is matched to the
tinnitus group with respect to age and hearing loss. The third group has no
hearing loss and has no tinnitus.
Study burden and risks
The total testing time per subject is maximally 6 hours, including breaks.
During these 6 hours, subjects perform gap detection tests. This testing
requires concentration of the subject, and is therefore fatiguing. Therefore,
frequent breaks will be included, and the testing time will be distributed over
2 or 3 sessions, with one session per day. Participation in this study, offers
no known risk to the participants.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
- adults, age>18 years
- tinnitus (group 1) or no tinnitus (group 2);- adults, age 18- reference group (healthy subjects)
Exclusion criteria
- a psychiatric condition needing treatment from a psychiater
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL42134.042.12 |