Clinical trial NCT02408575: Hearing Aids With "Notched Amplification" for the Treatment of Chronic Tinnitus
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
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Lead sponsor: University of Regensburg
Sponsor class: OTHER
First posted: 2015-04-03
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Mini Tinnitus Questionnaire (Mini-TQ12 of Göbel&Hiller)
timeFrame: Week 12
Secondary outcomes:
measure: Adverse events
timeFrame: Week 2
measure: Adverse events
timeFrame: Week 4
measure: Adverse events
timeFrame: Week 8
measure: Adverse events
timeFrame: Week 12
measure: Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller)
timeFrame: Week 2
measure: Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller)
timeFrame: Week 4
measure: Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller)
timeFrame: Week 8
measure: Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller)
timeFrame: Week 12
measure: Changes of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI of Newman et al 1996)
timeFrame: Week 2
measure: Changes of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI of Newman et al 1996)
timeFrame: Week 4
measure: Changes of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI of Newman et al 1996)
timeFrame: Week 8
measure: Changes of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI of Newman et al 1996)
timeFrame: Week 12
measure: Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12)
timeFrame: Week 2
measure: Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12)
timeFrame: Week 4
measure: Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12)
timeFrame: Week 8
measure: Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12)
timeFrame: Week 12
measure: Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI)
timeFrame: Week 2
measure: Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI)
timeFrame: Week 4
measure: Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI)
timeFrame: Week 8
measure: Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI)
timeFrame: Week 12
measure: Change in quality of life as measured by the WHOQoL questionnaire
timeFrame: Week 2
measure: Change in quality of life as measured by the WHOQoL questionnaire
timeFrame: Week 4
measure: Change in quality of life as measured by the WHOQoL questionnaire
timeFrame: Week 8
measure: Change in quality of life as measured by the WHOQoL questionnaire
timeFrame: Week 12
measure: Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales)
timeFrame: Week 2
measure: Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales)
timeFrame: Week 4
measure: Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales)
timeFrame: Week 8
measure: Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales)
timeFrame: Week 12
measure: Changes in psychoacoustic tinnitus characteristics
timeFrame: Week 2
measure: Changes in psychoacoustic tinnitus characteristics
timeFrame: Week 4
measure: Changes in psychoacoustic tinnitus characteristics
timeFrame: Week 8
measure: Changes in psychoacoustic tinnitus characteristics
timeFrame: Week 12
measure: Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
timeFrame: Week 2
measure: Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
timeFrame: Week 4
measure: Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
timeFrame: Week 8
measure: Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
timeFrame: Week 12
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: University of Regensburg - Dept of Psychiatry and ENT Dept.
Study officials:
affiliation: University of Regensburg
name: Berthold Langguth, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: