The main objective of this study is to compare the brainstem sound-evoked response of the subject groups with different hearing loss laterality and with/without tinnitus. These comparisons may let us know if the function of the human brainstem is…
ID
Source
Brief title
Condition
- Aural disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoints are differences between response characteristics associated
with hearing loss laterality and the presence of tinnitus. These differences
include the difference in the response amplitudes of various brainstem nuclei
as assessed by fMRI, BERA and, tonotopic maps as assessed by MRI.
Secondary outcome
n.v.t
Background summary
The tonotopic map of the brain auditory area represents the neurofunctional
organization, the localization of the neurons tuned to each frequency band. In
the animals and humans with induced tinnitus, the tonotopic map of the cortex
is changed. The functional organization of the cortex deviates in animals with
induced tinnitus (Engineer et al. 2011). Also, a recent study (Koops et al.
2019) suggests that higher frequencies are dominant in the tonotopic map of
humans with bilateral hearing loss. This result differs from an animal study
which reported an overrepresentation of lower frequencies in animals with
unilateral hearing loss. Linking the results from the literature not only
implies that hearing loss plays an influential role in neuroplasticity, but
also the laterality of hearing loss might have a significant impact. Therefore,
in this study, we compare the neural function of the human brainstem in
subjects with unilateral hearing loss, bilateral hearing loss, and presence
tinnitus, and we expect to observe a difference across the groups. Also, we
include subjects without hearing impairment (as the controls) for comparison to
the other groups.
Study objective
The main objective of this study is to compare the brainstem sound-evoked
response of the subject groups with different hearing loss laterality and
with/without tinnitus. These comparisons may let us know if the function of the
human brainstem is different in unilateral hearing loss, bilateral hearing
loss, and tinnitus.
Study design
This is an exploratory case-control study in which six groups of human subjects
are compared. This study design allows us to disentangle the contributions that
hearing loss and tinnitus have to functional changes in the brainstem,
respectively.
Study burden and risks
Each participant is asked to fill in a number of questionnaires regarding
handedness, MRI compatibility, and hyperacusis. Also, tinnitus patients fill in
questionnaires regarding their tinnitus. The questionnaire part takes 30
minutes in total. Then, using clinical audiometry, we measure the hearing
thresholds of the subject and perform a loudness matching task to determine
stimulus levels to be used in subsequent MRI sessions. This takes 50 minutes.
The functional MRI session via a 3-Tesla MRI scanner takes 60 minutes. Also,
the auditory brainstem response measurement takes 40 minutes. None of the
procedures has a known benefit or risk for the participant.
Hanzeplein 1
Groningen 9700RB
NL
Hanzeplein 1
Groningen 9700RB
NL
Listed location countries
Age
Inclusion criteria
To be eligible to participate in this study, the subject
- must be in the age range of 18-80 years old.
- must have a hearing threshold of both ears between 40 dB and 60 dB, if he/she
is in one of the bilateral hearing loss groups.
- must have a hearing threshold between 40 dB and 60 dB for one ear, and the
normal hearing threshold, less than 20 dB, for the other ear, if he/she is in
one of the unilateral hearing loss groups.
- must have a hearing threshold of less than 20 dB for both ears, if he/she is
in one of the normal threshold groups.
Exclusion criteria
- Non-conformance to any of the inclusion criteria.
- Contraindication for MRI according to the MRI checklist.
- Reported medical, neurological, or psychiatric disorders (excluding tinnitus
and hearing loss).
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 | NL69189.042.19 |