Hearing Aids With "Notched Amplification" for the Treatment of Chronic Tinnitus (NoA-Tin)

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

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.

Study Overview

• Status: Completed
• Conditions: Tinnitus
• Intervention / Treatment: Device: Notched filtering (verum); Device: No filtering (placebo)

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Regensburg, Germany, 93053
    • University of Regensburg - Dept of Psychiatry and ENT Dept.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Device: 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: 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	Device: No filtering (placebo); Conventional hearing aid type Carat 7bx with M-Receiver Adjustment by Connexx 7.3 No notched filtering

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

Collaborators and Investigators

• Sponsor: University of Regensburg
• Investigators: Principal Investigator: Berthold Langguth, M.D., Ph.D., University of Regensburg

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (ACTUAL): June 1, 2016
• Study Completion (ACTUAL): June 1, 2016

Study Registration Dates

• First Submitted: March 18, 2015
• First Submitted That Met QC Criteria: April 2, 2015
• First Posted (ESTIMATE): April 3, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): October 26, 2016
• Last Update Submitted That Met QC Criteria: October 25, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Tinnitus
• Other Study ID Numbers: Uni-Reg-NoA-Tin