No registrations found.
ID
Source
Health condition
Tinnitus - oorsuizen
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study variable is the intensity of the experienced tinnitus. The tinnitus intensity will be ranked on a Visual Analogue Scale (VAS).
Secondary outcome
1. Tinnitus Questionnaire;
2. Tinnitus Handicap Inventory;
3. Tinnitus Loudness Matching;
4. Residual Inhibition.
Background summary
Recruitment will be accomplished in The Netherlands.
Study objective
Tinnitus (Aurium) is a symptom characterized by the perception of sound or noise in the absence of any objective external physical source. This disorder affects millions of people worldwide; its precise pathophysiologic mechanism is unknown. It has yet remained refractory to current medical treatment. It is supposed that tinnitus might be suppressed by restoring peripheral auditory neural activity. In clinical practice, conventional hearing aids are often used for this purpose with only limited success. When using a cochlear implant (CI), prior studies show tinnitus suppression in 65%-93% of the cases . It is hypothesized that the suppressive effect of electrical stimulation by CI is due to restoring the code of silence in the cochlea and is also feasible with a simple stimulation pattern (i.e. without environmental sound perception). Moreover, it is hypothesized that this effect can be maintained over time.
Study design
At regular base after CI implantation for adjustments of CI-settings and during the study.
Intervention
Control intervention: Standard CI.
Intervention: Subject specific optimal simple electrical stimulation (i.e. electrical stimulation independent of environmental sounds).
During the crossover study both conditions are alternated in three months intervals.
Postbus 5800
R.A.G.J. Arts
Maastricht 6202 AZ
The Netherlands
+31 (0)43 3881184
remo.arts@mumc.nl
Postbus 5800
R.A.G.J. Arts
Maastricht 6202 AZ
The Netherlands
+31 (0)43 3881184
remo.arts@mumc.nl
Inclusion criteria
1. Ipsilateral: Severely hearing-impaired;
2. Contralateral: Moderate to normal hearing;
3. Experiencing tinnitus which is:
A. Continuous;
B. Ipsilaterally localized;
C. Characterized as a pure tone;
D. Severe;
E. Stable;
F. No reported suppressive effect from hearing aids.
4. Willingness to participate in this research.
Exclusion criteria
1. Pulsatile tinnitus;
2. Ménière disease;
3. History of psychiatric or neurological disorders or depression;
4. Use of antidepressant medication;
5. Cochleovestibular neurovascular conflict;
6. Congenital malformalities in auditory system;
7. History of vestibular schwannoma;
8. Ossified cochlea;
9. Active middle ear disease;
10. Age < 18 years old.
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 |
|---|---|
| NTR-new | NL3222 |
| NTR-old | NTR3374 |
| Other | NL38789.068.11 : 11-2-093 METC MUMC |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |