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…
ID
Bron
Aandoening
Tinnitus - oorsuizen
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary study variable is the intensity of the experienced tinnitus. The tinnitus intensity will be ranked on a Visual Analogue Scale (VAS).
Achtergrond van het onderzoek
Recruitment will be accomplished in The Netherlands.
Doel van het onderzoek
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.
Onderzoeksopzet
At regular base after CI implantation for adjustments of CI-settings and during the study.
Onderzoeksproduct en/of interventie
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.
Publiek
Postbus 5800
R.A.G.J. Arts
Maastricht 6202 AZ
The Netherlands
+31 (0)43 3881184
remo.arts@mumc.nl
Wetenschappelijk
Postbus 5800
R.A.G.J. Arts
Maastricht 6202 AZ
The Netherlands
+31 (0)43 3881184
remo.arts@mumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3222 |
| NTR-old | NTR3374 |
| Ander register | NL38789.068.11 : 11-2-093 METC MUMC |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |