Pilot study on safety, tolerability and clinical performance/randomized double-blind active-controlled pilot-study. Patients are being recruited from patients of the Tinnitus Center of Regensburg and groupwise randomized. Control groups are being treated with hearing aids without notch-filter. Patients and raters are blinded, only the coworker, who is programming the hearing aids, is informed about the group assigned. A Hearing aid with notched amplification filters frequencies in a specific manner, depending on the individual tinnitus frequency. Through this special filtering the neuronal functional changes of the auditory cortex are supposed to be affected therapeutically.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
44
Conventional hearing aid type Carat 7bx with M-Receiver Adjustment by Connexx 7.3 The Hearing aid with notched amplification filters frequences in a specific manner, depending on the individual tinnitus frequency. Through this special filtering the neuronal functional changes of the auditory cortex are supposed to be affected therapeutically.
Conventional hearing aid type Carat 7bx with M-Receiver Adjustment by Connexx 7.3 No notched filtering
University of Regensburg - Dept of Psychiatry and ENT Dept.
Regensburg, Germany
Mini Tinnitus Questionnaire (Mini-TQ12 of Göbel&Hiller)
Reduction in the sumscore means improvement of tinnitus
Time frame: Week 12
Adverse events
Time frame: Week 2
Adverse events
Time frame: Week 4
Adverse events
Time frame: Week 8
Adverse events
Time frame: Week 12
Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller)
Reduction in the sumscore means improvement of tinnitus
Time frame: Week 2
Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller)
Reduction in the sumscore means improvement of tinnitus
Time frame: Week 4
Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller)
Reduction in the sumscore means improvement of tinnitus
Time frame: Week 8
Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller)
Time frame: Week 12
Changes of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI of Newman et al 1996)
Reduction in the sumscore means improvement of tinnitus
Time frame: Week 2
Changes of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI of Newman et al 1996)
Reduction in the sumscore means improvement of tinnitus
Time frame: Week 4
Changes of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI of Newman et al 1996)
Reduction in the sumscore means improvement of tinnitus
Time frame: Week 8
Changes of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI of Newman et al 1996)
Reduction in the sumscore means improvement of tinnitus
Time frame: Week 12
Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12)
Reduction in the sumscore means improvement of tinnitus
Time frame: Week 2
Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12)
Reduction in the sumscore means improvement of tinnitus
Time frame: Week 4
Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12)
Reduction in the sumscore means improvement of tinnitus
Time frame: Week 8
Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12)
Reduction in the sumscore means improvement of tinnitus
Time frame: Week 12
Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI)
Reduction in the sumscore means improvement of tinnitus
Time frame: Week 2
Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI)
Reduction in the sumscore means improvement of tinnitus
Time frame: Week 4
Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI)
Reduction in the sumscore means improvement of tinnitus
Time frame: Week 8
Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI)
Reduction in the sumscore means improvement of tinnitus
Time frame: Week 12
Change in quality of life as measured by the WHOQoL questionnaire
Reduction in the sumscore means improvement of tinnitus
Time frame: Week 2
Change in quality of life as measured by the WHOQoL questionnaire
Reduction in the sumscore means improvement of tinnitus
Time frame: Week 4
Change in quality of life as measured by the WHOQoL questionnaire
Reduction in the sumscore means improvement of tinnitus
Time frame: Week 8
Change in quality of life as measured by the WHOQoL questionnaire
Reduction in the sumscore means improvement of tinnitus
Time frame: Week 12
Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales)
Reduction in the sumscore means improvement of tinnitus
Time frame: Week 2
Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales)
Reduction in the sumscore means improvement of tinnitus
Time frame: Week 4
Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales)
Reduction in the sumscore means improvement of tinnitus
Time frame: Week 8
Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales)
Reduction in the sumscore means improvement of tinnitus
Time frame: Week 12
Changes in psychoacoustic tinnitus characteristics
frequency, loudness, minimal masking level
Time frame: Week 2
Changes in psychoacoustic tinnitus characteristics
frequency, loudness, minimal masking level
Time frame: Week 4
Changes in psychoacoustic tinnitus characteristics
frequency, loudness, minimal masking level
Time frame: Week 8
Changes in psychoacoustic tinnitus characteristics
frequency, loudness, minimal masking level
Time frame: Week 12
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Time frame: Week 2
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Time frame: Week 4
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Time frame: Week 8
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Time frame: Week 12
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