Most patients with tinnitus also have a hearing loss. The primary goal of this study is to investigate whether in patients with hearing loss AND tinnitus, the neural response of the brain is enlarged compared to hearing-impaired patients without…
ID
Source
Brief title
Condition
- Hearing disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- audiometric test outcomes
- scores of questionnaires
- fMRI response amplitude of auditory and limbic brain areas
Secondary outcome
n.a.
Background summary
Tinnitus is possibly based on abnormal neural activity of the central auditory
system. Earlier research showed that in patients with near-normal hearing the
response to sound of the brain was enlarged in comparison to that in subjects
without tinnitus.
Study objective
Most patients with tinnitus also have a hearing loss. The primary goal of this
study is to investigate whether in patients with hearing loss AND tinnitus, the
neural response of the brain is enlarged compared to hearing-impaired patients
without tinnitus. In addition, we will investigate whether the response of the
brain is related to the severity of tinnitus.
Study design
Patients undergo ENT-investigation, extensive audiometric testing and will
complete a number of questionnaires on tinnitus and related fear and anxiety.
In addition, fMRI will be carried out, in order to measure the response of the
brain to sound. The outcome of the fMRI measurement will be correlated with the
outcome of the ENT-investigation, the audiometry and the questionnaires.
Study burden and risks
- There are no known risks associated with the study.
- Patients will spend a total of 340 minutes to this study. Hearing tests and
questionnaires will require their concentration.
Postbus 30001
9700 RB Groningen
NL
Postbus 30001
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
- Healthy subjects, at least 18 years old
- Audiometric tone threshold >=20 dB and <=60 dB for both ears on the octave frequencies 500, 1000, 2000, and 4000 Hz
- Subjects have signed informed consent in accordance with the Dutch legal regulation (Wet Medisch Wetenschappelijk Onderzoek met Mensen).
- No contradictions for fMRI according to the MRI-checklist
Exclusion criteria
- Presence of any major medical, neurological or psychiatric diagnoses now or in the past.
- Pregnancy
- Claustrophobia
- Epilepsy
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 | NL21088.042.07 |