Hearing Aids With "Notched Amplification" for the Treatment of Chronic Tinnitus - A Controlled Randomized Pilot Study on Safety, Tolerability and Clinical Performance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Mini Tinnitus Questionnaire (Mini-TQ12 of Göbel&Hiller)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Notched filtering (verum) (Device)
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
干预措施: No filtering (placebo) (Device)
结局指标
主要结局
Mini Tinnitus Questionnaire (Mini-TQ12 of Göbel&Hiller)
时间窗: Week 12
Reduction in the sumscore means improvement of tinnitus
次要结局
- Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales)(Week 12)
- 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)
- Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12)(Week 12)
- Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI)(Week 12)
- Change in quality of life as measured by the WHOQoL questionnaire(Week 12)
- Changes in psychoacoustic tinnitus characteristics(Week 12)
- Change of depressive symptoms as measured by the Major Depression Inventory (MDI)(Week 12)
- Adverse events(Week 2)
- Adverse events(Week 4)
- Adverse events(Week 8)
- Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller)(Week 2)
- Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller)(Week 4)
- Change of depressive symptoms as measured by the Major Depression Inventory (MDI)(Week 8)
- Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller)(Week 8)
- Changes of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI of Newman et al 1996)(Week 2)
- Changes of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI of Newman et al 1996)(Week 4)
- Changes of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI of Newman et al 1996)(Week 8)
- Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12)(Week 2)
- Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12)(Week 4)
- Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12)(Week 8)
- Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI)(Week 2)
- Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI)(Week 4)
- Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI)(Week 8)
- Change in quality of life as measured by the WHOQoL questionnaire(Week 2)
- Change in quality of life as measured by the WHOQoL questionnaire(Week 4)
- Change in quality of life as measured by the WHOQoL questionnaire(Week 8)
- Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales)(Week 2)
- Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales)(Week 4)
- Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales)(Week 8)
- Changes in psychoacoustic tinnitus characteristics(Week 2)
- Changes in psychoacoustic tinnitus characteristics(Week 4)
- Changes in psychoacoustic tinnitus characteristics(Week 8)
- 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)
研究者
Berthold Langguth, MD, Ph.D.
Head of Outpatient Clinic
University of Regensburg