Overview

This trial has been completed.

Condition tinnitus
Treatments notched filtering (verum), no filtering (placebo)
Sponsor University of Regensburg
Start date February 2015
End date June 2016
Trial size 44 participants
Trial identifier NCT02408575, Uni-Reg-NoA-Tin

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(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
notched 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.
(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
no filtering (placebo)
Conventional hearing aid type Carat 7bx with M-Receiver Adjustment by Connexx 7.3 No notched filtering

Primary Outcomes

Measure
Mini Tinnitus Questionnaire (Mini-TQ12 of Göbel&Hiller)
time frame: Week 12

Secondary Outcomes

Measure
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)
time frame: Week 2
Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller)
time frame: Week 4
Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller)
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)
time frame: Week 2
Changes of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI of Newman et al 1996)
time frame: Week 4
Changes of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI of Newman et al 1996)
time frame: Week 8
Changes of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI of Newman et al 1996)
time frame: Week 12
Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12)
time frame: Week 2
Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12)
time frame: Week 4
Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12)
time frame: Week 8
Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12)
time frame: Week 12
Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI)
time frame: Week 2
Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI)
time frame: Week 4
Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI)
time frame: Week 8
Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI)
time frame: Week 12
Change in quality of life as measured by the WHOQoL questionnaire
time frame: Week 2
Change in quality of life as measured by the WHOQoL questionnaire
time frame: Week 4
Change in quality of life as measured by the WHOQoL questionnaire
time frame: Week 8
Change in quality of life as measured by the WHOQoL questionnaire
time frame: Week 12
Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales)
time frame: Week 2
Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales)
time frame: Week 4
Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales)
time frame: Week 8
Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales)
time frame: Week 12
Changes in psychoacoustic tinnitus characteristics
time frame: Week 2
Changes in psychoacoustic tinnitus characteristics
time frame: Week 4
Changes in psychoacoustic tinnitus characteristics
time frame: Week 8
Changes in psychoacoustic tinnitus characteristics
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

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official title Hearing Aids With "Notched Amplification" for the Treatment of Chronic Tinnitus - A Controlled Randomized Pilot Study on Safety, Tolerability and Clinical Performance
Principal investigator Berthold Langguth, M.D., Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Regensburg.