Hearing Aids With "Notched Amplification" for the Treatment of Chronic Tinnitus

Not Applicable

Completed

• Conditions: Tinnitus
• Interventions: Device: No filtering (placebo); Device: Notched filtering (verum)

• Registration Number: NCT02408575
• Lead Sponsor: University of Regensburg

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-03-18
• Study First Submitted QC: 2015-04-02
• Study First Posted: 2015-04-03
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-25
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No filtering (placebo)	No filtering (placebo)	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
Notched filtering (verum)	Notched filtering (verum)	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

Primary Outcome Measures

Name	Time	Method
Mini Tinnitus Questionnaire (Mini-TQ12 of Göbel&Hiller)	Week 12	Reduction in the sumscore means improvement of tinnitus

Secondary Outcome Measures

Name	Time	Method
Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales)	Week 12	Reduction in the sumscore means improvement of tinnitus
Adverse events	Week 12
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)	Week 12	Reduction in the sumscore means improvement of tinnitus
Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12)	Week 12	Reduction in the sumscore means improvement of tinnitus
Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI)	Week 12	Reduction in the sumscore means improvement of tinnitus
Change in quality of life as measured by the WHOQoL questionnaire	Week 12	Reduction in the sumscore means improvement of tinnitus
Changes in psychoacoustic tinnitus characteristics	Week 12	frequency, loudness, minimal masking level
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)	Week 12

Trial Locations

Locations (1)

University of Regensburg - Dept of Psychiatry and ENT Dept.; 🇩🇪 Regensburg, Germany