Tinnitus
Conditions
Keywords
Pulsatile Tinnitus, Ringing-Buzzing-Tinnitus, Spontaneous Oto-Acoustic Emission Tinnitus, Tensor Palatini Induced Tinnitus, Tensor Tympani Induced Tinnitus, Tinnitus of Vascular Origin, Tinnitus, Clicking, Tinnitus, Leudet, Tinnitus, Leudet's, Tinnitus, Noise Induced, Tinnitus, Objective, Tinnitus, Spontaneous Oto-Acoustic Emission, Tinnitus, Subjective, Tinnitus, Tensor Palatini Induced, Tinnitus, Tensor Tympani Induced, Vascular Origin Tinnitus
Brief summary
The t-VNS STv3 device is a non-invasive, transcutaneous neurostimulator for influencing the afferent branches of the nervus vagus around the human ear. The clinical trial is designed as a a pilot study addressing the treatment of tinnitus with transcutaneous vagus nerve stimulation.
Interventions
DEVICEtVNS-Device
Active treatment with the t-VNS device.
Sponsors
cerbomed GmbH
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Chronic tinnitus defined as a tinnitus over more than six months * ≥31 points in the tinnitus questionnaire according to Goebel and Hiller * Written informed consent * Both gender, aged from 18 -75 years * If the subject takes psychoactive medication (e.g antidepressants, anticonvulsives) therapy must be stable for at least 10 days. If a treatment with neuroleptics is necessary, only olanzapine and quetiapine should be used. The therapy should be constantly though a necessary change in medication is no reason for exclusion of the subject.
Exclusion criteria
* Objective tinnitus * Participating in other tinnitus treatments within 3 months before study start * Missing informed consent * Pregnancy * Bronchial asthma in medical history * Clinically relevant internistic, neurological or psychiatric diseases * Abuse of drugs or alcohol until 12 weeks before enrollment in the study * Indications of structural impairment of the basal ganglia or the brain stem * Active implants (e.g. cochlea implants, VNS, pacemaker) * Constant all-day use of hearing instruments or noisers on the left the part-time use in special situations (e.g. watching TV is no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety, feasibility and effectiveness of t-VNS® stimulation | 24 weeks | Determination of safety, feasibility and effectiveness of t-VNS measured by tinnitus score according to Goebel and Hiller between baseline and week 24 |
Countries
Germany
Outcome results
None listed