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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Notched filtering (verum) | Experimental | The 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. Intervention: Device: Conventional hearing aid type Carat 7bx with M-Receiver; Adjustment by Connexx 7.3 |
|
| No filtering (placebo) | Experimental | Conventional hearing aid type Carat 7bx with M-Receiver Adjustment by Connexx 7.3 No notched filtering Intervention: Device: Conventional hearing aid type Carat 7bx with M-Receiver; Adjustment by Connexx 7.3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Notched filtering (verum) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mini Tinnitus Questionnaire (Mini-TQ12 of Göbel&Hiller) | Reduction in the sumscore means improvement of tinnitus | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Week 2 | |
| Adverse events | Week 4 | |
| Adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Berthold Langguth, M.D., Ph.D. | University of Regensburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Regensburg - Dept of Psychiatry and ENT Dept. | Regensburg | 93053 | Germany |
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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|
| No filtering (placebo) | Device | Conventional hearing aid type Carat 7bx with M-Receiver Adjustment by Connexx 7.3 No notched filtering |
|
| Week 8 |
| Adverse events | Week 12 |
| Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller) | Reduction in the sumscore means improvement of tinnitus | Week 2 |
| Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller) | Reduction in the sumscore means improvement of tinnitus | Week 4 |
| Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller) | Reduction in the sumscore means improvement of tinnitus | Week 8 |
| Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller) | 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 | 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 | 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 | 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 | Week 12 |
| Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12) | Reduction in the sumscore means improvement of tinnitus | Week 2 |
| Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12) | Reduction in the sumscore means improvement of tinnitus | Week 4 |
| Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12) | Reduction in the sumscore means improvement of tinnitus | Week 8 |
| Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12) | Reduction in the sumscore means improvement of tinnitus | Week 12 |
| Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI) | Reduction in the sumscore means improvement of tinnitus | Week 2 |
| Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI) | Reduction in the sumscore means improvement of tinnitus | Week 4 |
| Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI) | Reduction in the sumscore means improvement of tinnitus | Week 8 |
| Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI) | Reduction in the sumscore means improvement of tinnitus | Week 12 |
| Change in quality of life as measured by the WHOQoL questionnaire | Reduction in the sumscore means improvement of tinnitus | Week 2 |
| Change in quality of life as measured by the WHOQoL questionnaire | Reduction in the sumscore means improvement of tinnitus | Week 4 |
| Change in quality of life as measured by the WHOQoL questionnaire | Reduction in the sumscore means improvement of tinnitus | Week 8 |
| Change in quality of life as measured by the WHOQoL questionnaire | Reduction in the sumscore means improvement of tinnitus | Week 12 |
| Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales) | Reduction in the sumscore means improvement of tinnitus | Week 2 |
| Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales) | Reduction in the sumscore means improvement of tinnitus | Week 4 |
| Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales) | Reduction in the sumscore means improvement of tinnitus | Week 8 |
| Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales) | Reduction in the sumscore means improvement of tinnitus | Week 12 |
| Changes in psychoacoustic tinnitus characteristics | frequency, loudness, minimal masking level | Week 2 |
| Changes in psychoacoustic tinnitus characteristics | frequency, loudness, minimal masking level | Week 4 |
| Changes in psychoacoustic tinnitus characteristics | frequency, loudness, minimal masking level | Week 8 |
| Changes in psychoacoustic tinnitus characteristics | frequency, loudness, minimal masking level | Week 12 |
| Change of depressive symptoms as measured by the Major Depression Inventory (MDI) | Week 2 |
| Change of depressive symptoms as measured by the Major Depression Inventory (MDI) | Week 4 |
| Change of depressive symptoms as measured by the Major Depression Inventory (MDI) | Week 8 |
| Change of depressive symptoms as measured by the Major Depression Inventory (MDI) | Week 12 |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |