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

Primary Purpose

Tinnitus

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Notched filtering (verum)
No filtering (placebo)
Sponsored by
University of Regensburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Regensburg - Dept of Psychiatry and ENT Dept.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Notched filtering (verum)

No filtering (placebo)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Mini Tinnitus Questionnaire (Mini-TQ12 of Göbel&Hiller)
Reduction in the sumscore means improvement of tinnitus

Secondary Outcome Measures

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

Full Information

First Posted
March 18, 2015
Last Updated
October 25, 2016
Sponsor
University of Regensburg
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1. Study Identification

Unique Protocol Identification Number
NCT02408575
Brief Title
Hearing Aids With "Notched Amplification" for the Treatment of Chronic Tinnitus
Acronym
NoA-Tin
Official Title
Hearing Aids With "Notched Amplification" for the Treatment of Chronic Tinnitus - A Controlled Randomized Pilot Study on Safety, Tolerability and Clinical Performance
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Regensburg

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Notched filtering (verum)
Arm Type
Experimental
Arm Description
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
Arm Title
No filtering (placebo)
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Notched filtering (verum)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
No filtering (placebo)
Intervention Description
Conventional hearing aid type Carat 7bx with M-Receiver Adjustment by Connexx 7.3 No notched filtering
Primary Outcome Measure Information:
Title
Mini Tinnitus Questionnaire (Mini-TQ12 of Göbel&Hiller)
Description
Reduction in the sumscore means improvement of tinnitus
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
Week 2
Title
Adverse events
Time Frame
Week 4
Title
Adverse events
Time Frame
Week 8
Title
Adverse events
Time Frame
Week 12
Title
Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller)
Description
Reduction in the sumscore means improvement of tinnitus
Time Frame
Week 2
Title
Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller)
Description
Reduction in the sumscore means improvement of tinnitus
Time Frame
Week 4
Title
Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller)
Description
Reduction in the sumscore means improvement of tinnitus
Time Frame
Week 8
Title
Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller)
Time Frame
Week 12
Title
Changes of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI of Newman et al 1996)
Description
Reduction in the sumscore means improvement of tinnitus
Time Frame
Week 2
Title
Changes of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI of Newman et al 1996)
Description
Reduction in the sumscore means improvement of tinnitus
Time Frame
Week 4
Title
Changes of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI of Newman et al 1996)
Description
Reduction in the sumscore means improvement of tinnitus
Time Frame
Week 8
Title
Changes of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI of Newman et al 1996)
Description
Reduction in the sumscore means improvement of tinnitus
Time Frame
Week 12
Title
Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12)
Description
Reduction in the sumscore means improvement of tinnitus
Time Frame
Week 2
Title
Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12)
Description
Reduction in the sumscore means improvement of tinnitus
Time Frame
Week 4
Title
Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12)
Description
Reduction in the sumscore means improvement of tinnitus
Time Frame
Week 8
Title
Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12)
Description
Reduction in the sumscore means improvement of tinnitus
Time Frame
Week 12
Title
Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI)
Description
Reduction in the sumscore means improvement of tinnitus
Time Frame
Week 2
Title
Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI)
Description
Reduction in the sumscore means improvement of tinnitus
Time Frame
Week 4
Title
Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI)
Description
Reduction in the sumscore means improvement of tinnitus
Time Frame
Week 8
Title
Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI)
Description
Reduction in the sumscore means improvement of tinnitus
Time Frame
Week 12
Title
Change in quality of life as measured by the WHOQoL questionnaire
Description
Reduction in the sumscore means improvement of tinnitus
Time Frame
Week 2
Title
Change in quality of life as measured by the WHOQoL questionnaire
Description
Reduction in the sumscore means improvement of tinnitus
Time Frame
Week 4
Title
Change in quality of life as measured by the WHOQoL questionnaire
Description
Reduction in the sumscore means improvement of tinnitus
Time Frame
Week 8
Title
Change in quality of life as measured by the WHOQoL questionnaire
Description
Reduction in the sumscore means improvement of tinnitus
Time Frame
Week 12
Title
Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales)
Description
Reduction in the sumscore means improvement of tinnitus
Time Frame
Week 2
Title
Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales)
Description
Reduction in the sumscore means improvement of tinnitus
Time Frame
Week 4
Title
Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales)
Description
Reduction in the sumscore means improvement of tinnitus
Time Frame
Week 8
Title
Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales)
Description
Reduction in the sumscore means improvement of tinnitus
Time Frame
Week 12
Title
Changes in psychoacoustic tinnitus characteristics
Description
frequency, loudness, minimal masking level
Time Frame
Week 2
Title
Changes in psychoacoustic tinnitus characteristics
Description
frequency, loudness, minimal masking level
Time Frame
Week 4
Title
Changes in psychoacoustic tinnitus characteristics
Description
frequency, loudness, minimal masking level
Time Frame
Week 8
Title
Changes in psychoacoustic tinnitus characteristics
Description
frequency, loudness, minimal masking level
Time Frame
Week 12
Title
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Time Frame
Week 2
Title
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Time Frame
Week 4
Title
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Time Frame
Week 8
Title
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berthold Langguth, M.D., Ph.D.
Organizational Affiliation
University of Regensburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Regensburg - Dept of Psychiatry and ENT Dept.
City
Regensburg
ZIP/Postal Code
93053
Country
Germany

12. IPD Sharing Statement

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

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