Tinnitus
Conditions
Brief summary
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.
Interventions
DEVICENotched filtering (verum)
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.
DEVICENo filtering (placebo)
Conventional hearing aid type Carat 7bx with M-Receiver Adjustment by Connexx 7.3 No notched filtering
Sponsors
University of Regensburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Chronic tinnitus (≥ 6 months) * Score of ≥ 10 in TQ12 (Goebel und Hiller) * Mild to moderate hearing loss of at least 20 dB and maximum 70 dB between 250 Hz and 8 kHz * Tinnitus with tonal character or narrow band noise (\< 1 oktave bandwidth) * Tinnitus frequency ≤ 8 kHz in tinnitus matching * Written informed consent of the proband * If therapy with psychoactive substances is necessary, it has to be stable during at least 10 days and should remain constant during study (changes will be documented in the CRF) * No regular use (8 hours daily) of hearing aids during 3 month before start of study
Exclusion criteria
* Objective Tinnitus * Start of other tinnitus therapies during 3 months before start of study. * Missing written consent * Clinically relevant serious internal, neurologic or psychiatric diseases * Abuse of drugs, medicaments and alcohol up to 12 weeks before start of study * Other circumstances that object to study inclusion according to the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mini Tinnitus Questionnaire (Mini-TQ12 of Göbel&Hiller) | Week 12 | Reduction in the sumscore means improvement of tinnitus |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller) | Week 2 | Reduction in the sumscore means improvement of tinnitus |
| Changes of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI of Newman et al 1996) | Week 2 | Reduction in the sumscore means improvement of tinnitus |
| Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12) | Week 2 | Reduction in the sumscore means improvement of tinnitus |
| Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI) | Week 2 | Reduction in the sumscore means improvement of tinnitus |
| Adverse events | Week 2 | — |
| Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales) | Week 2 | Reduction in the sumscore means improvement of tinnitus |
| Changes in psychoacoustic tinnitus characteristics | Week 2 | frequency, loudness, minimal masking level |
| Change of depressive symptoms as measured by the Major Depression Inventory (MDI) | Week 2 | — |
| Change in quality of life as measured by the WHOQoL questionnaire | Week 2 | Reduction in the sumscore means improvement of tinnitus |
Countries
Germany
Outcome results
None listed