Hearing Aids With Notched Amplification for the Treatment of Chronic Tinnitus

Study Overview
=================
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.

Official Title
-----------------
Hearing Aids With Notched Amplification for the Treatment of Chronic Tinnitus - A Controlled Randomized Pilot Study on Safety, Tolerability and Clinical Performance

Conditions
-----------------
Tinnitus

Intervention / Treatment
-----------------
* Device: Notched filtering (verum)
* Device: No filtering (placebo)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Notched filtering (verum)<br>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 | Device: Notched filtering (verum)<br>* 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.<br>|
| Experimental: No filtering (placebo)<br>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 | Device: No filtering (placebo)<br>* Conventional hearing aid type Carat 7bx with M-Receiver Adjustment by Connexx 7.3 No notched filtering<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini Tinnitus Questionnaire (Mini-TQ12 of Göbel&Hiller) | Reduction in the sumscore means improvement of tinnitus | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | Week 2 | 
| Adverse events |  | Week 4 | 
| Adverse events |  | 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 |