l Prospective Clinical Investigation on the Acoustic Stimulation With the "Coordinated Reset of Neural Subpopulations" in the Treatment of Chronic Tinnitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
研究概览
简要总结
There are many treatments for chronic tinnitus that have been claimed, with varying degrees of statistical reliability. None of those treatments can eradicate the tinnitus completely. Some therapies can reduce the tinnitus symptoms (loudness, annoyance) up to 30%. Thus there is still a need of new treatments that can reduce considerably the tinnitus symptoms and improve the QOL of subjects.
Trial objectives:
- The aim of this trial is the improvement of the QOL (quality of live) by reducing the Tinnitus- Symptoms of the patient.
- To confirm the efficacy and safety of the coordinated reset technology.
These objectives will be assessed:
- By subjective and objective measurements of the Tinnitus symptoms, loudness and annoyance.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mentally healthy people
- •Chronic tonal Tinnitus
- •Older than 18 years
- •Signature of the patient informed consent
- •No participation in other tinnitus therapy during the clinical investigation
排除标准
- •A necessity for hearing aid
- •Auditory hallucination
- •Symptomatic hearing disorders
- •"Morbus Meniere",
- •Tinnitus due to temporomandibular joint disorders
- •Subjects who can't perceive therapeutic tones
- •Brainstem diseases
- •Psychiatric disorders
- •Objective Tinnitus
- •Insufficient treatment of general disorders, anemia, tumor, dialysis, hypertonus ect.
研究组 & 干预措施
Group 1 : G_1
G_1: stimulation for 4 - 6 hours a day, 4 tones per sequence
干预措施: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset (Device)
Group 2 :G_2
G_2: stimulation for 4 - 6 hours a day with 12-tone sequences
干预措施: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset (Device)
Group3 : G_3
G_3: stimulation for 4 - 6 hours a day, 4 tones per sequence with a signal controlled by EEG measurement
干预措施: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset (Device)
Group 4 : G_4
G_4: stimulation for 1 hour a day, 4 tones per sequence
干预措施: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset (Device)
Group5 : G_5
G_5: stimulation with placebo-tone
干预措施: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset (Device)