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

Tinnitus Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02408575
• Other study ID #: Uni-Reg-NoA-Tin
• Status: Completed
• Phase: N/A
• First received: March 18, 2015
• Last updated: October 25, 2016
• Start date: February 2015
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: University of Regensburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus

Intervention

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.
• No filtering (placebo)
Conventional hearing aid type Carat 7bx with M-Receiver Adjustment by Connexx 7.3 No notched filtering

Locations

Country	Name	City	State
Germany	University of Regensburg - Dept of Psychiatry and ENT Dept.	Regensburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Regensburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mini Tinnitus Questionnaire (Mini-TQ12 of Göbel&Hiller)	Reduction in the sumscore means improvement of tinnitus	Week 12	No
Secondary	Adverse events		Week 2	No
Secondary	Adverse events		Week 4	No
Secondary	Adverse events		Week 8	No
Secondary	Adverse events		Week 12	No
Secondary	Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller)	Reduction in the sumscore means improvement of tinnitus	Week 2	No
Secondary	Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller)	Reduction in the sumscore means improvement of tinnitus	Week 4	No
Secondary	Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller)	Reduction in the sumscore means improvement of tinnitus	Week 8	No
Secondary	Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller)		Week 12	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12)	Reduction in the sumscore means improvement of tinnitus	Week 2	No
Secondary	Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12)	Reduction in the sumscore means improvement of tinnitus	Week 4	No
Secondary	Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12)	Reduction in the sumscore means improvement of tinnitus	Week 8	No
Secondary	Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12)	Reduction in the sumscore means improvement of tinnitus	Week 12	No
Secondary	Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI)	Reduction in the sumscore means improvement of tinnitus	Week 2	No
Secondary	Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI)	Reduction in the sumscore means improvement of tinnitus	Week 4	No
Secondary	Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI)	Reduction in the sumscore means improvement of tinnitus	Week 8	No
Secondary	Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI)	Reduction in the sumscore means improvement of tinnitus	Week 12	No
Secondary	Change in quality of life as measured by the WHOQoL questionnaire	Reduction in the sumscore means improvement of tinnitus	Week 2	No
Secondary	Change in quality of life as measured by the WHOQoL questionnaire	Reduction in the sumscore means improvement of tinnitus	Week 4	No
Secondary	Change in quality of life as measured by the WHOQoL questionnaire	Reduction in the sumscore means improvement of tinnitus	Week 8	No
Secondary	Change in quality of life as measured by the WHOQoL questionnaire	Reduction in the sumscore means improvement of tinnitus	Week 12	No
Secondary	Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales)	Reduction in the sumscore means improvement of tinnitus	Week 2	No
Secondary	Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales)	Reduction in the sumscore means improvement of tinnitus	Week 4	No
Secondary	Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales)	Reduction in the sumscore means improvement of tinnitus	Week 8	No
Secondary	Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales)	Reduction in the sumscore means improvement of tinnitus	Week 12	No
Secondary	Changes in psychoacoustic tinnitus characteristics	frequency, loudness, minimal masking level	Week 2	No
Secondary	Changes in psychoacoustic tinnitus characteristics	frequency, loudness, minimal masking level	Week 4	No
Secondary	Changes in psychoacoustic tinnitus characteristics	frequency, loudness, minimal masking level	Week 8	No
Secondary	Changes in psychoacoustic tinnitus characteristics	frequency, loudness, minimal masking level	Week 12	No
Secondary	Change of depressive symptoms as measured by the Major Depression Inventory (MDI)		Week 2	No
Secondary	Change of depressive symptoms as measured by the Major Depression Inventory (MDI)		Week 4	No
Secondary	Change of depressive symptoms as measured by the Major Depression Inventory (MDI)		Week 8	No
Secondary	Change of depressive symptoms as measured by the Major Depression Inventory (MDI)		Week 12	No