Physiological Regulation of Chronic Tinnitus

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

unilateral, persistent and stable tinnitus for >11 weeks,
normal findings using an ear microscope,
normal tympanic membrane mobility and stapedial reflex,
ability to fill out relevant questionnaires,
gap between the sound pressure level in the audiometric tinnitus matching (tinnitus level above
threshold) and the tinnitus loudness (Zenner and de Maddalena, 2005).

Exclusion Criteria

pulsatile, intermittent, or non-persistent tinnitus,
bilateral tinnitus,
tinnitus as a concomitant symptom of a known systemic disease (such as vestibular schwannoma, endolymphatic hydrops, or Menière’s disease),
known retrocochlear hearing defect (such as those detected through brainstem evoked response audiometry),
conductive hearing loss exceeding 10 dB at two or more frequencies,
ear canal or middle ear inflammation or effusion,
one or two sided total deafness,
status following a craniocerebral trauma,
cervicogenic or stomatognatogenic tinnitus,
start of therapy with maskers 2 months preceding therapy,
start of autogenic training or psychotherapy <4 weeks before therapy,
ongoing acupuncture therapy,
drug treatment for tinnitus within 24 h preceding therapy,
inability to discontinue drugs known to be associated with tinnitus (high-dose aspirin, quinidine,
aminoglycosides) or psychotropic medication prior to entry into the study,
epilepsy,
age > 60,
Parkinson’s disease,
dementia,
acute allergic disease,
neurological or psychiatric disease,
drug or alcohol abuse that would interfere with regular completion of the study,
consuming diseases,
history of a severe ischemic disorder (previous stroke, previous heart attack, peripheral arterial
occlusion disease),
exposure to an investigational agent within the previous 4 weeks,
anticipated non-availability for study visits or procedures,
insufficient command of German.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primarily the focus is on changes of A1-EEG- alpha and delta power, and<br>tinnitus intensity (TIM) in the EG and CG as well as changes of tinnitus intensity (TIM), loudness<br>(VAS) and distress (VAS) by use of questionnaires in the EG, CG and CBT-group. The measurements are made in each session or daily, before treatment, at an interim time, after treatment and in follow-up; a total of at least 14 measurements are taken<br><br><br>

Secondary Outcome Measures