Clinical Trial of Sound-Based Versus Behavioral Therapy for Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Tinnitus Questionnaire (TQ)
研究概览
简要总结
The purpose of this study is to determine if a novel sound-based therapy in comparison to standard of care (cognitive behavioral therapy) results in reducing tinnitus-related effects for people with bothersome tinnitus.
详细描述
This study is a randomized controlled trial evaluating if a customized sound-therapy device is just as effective or more so, than the standard of care (cognitive behavioral therapy, CBT) for bothersome tinnitus. All eligible participants will be randomly assigned to one of the two groups. Depending on group assignment, participants will attend approximately 7-12 visits over a 7-month period.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years
- •Primary and persistent tinnitus (6 months or longer in duration)
- •Tonal tinnitus
- •Dominant tinnitus frequency measured between 0.2 and 10 kHz
- •Tinnitus Questionnaire score
- •No current participation in other tinnitus therapy program
- •Willing and able to listen to the acoustic prescription for 4-6 hours daily during the trial
- •Able to pass the Tone Audibility Assessment with factor of 1.1
排除标准
- •Secondary/somatic tinnitus due to a suspected underlying disease
- •Atonal, pulsatile, intermittent, or occasional tinnitus
- •Any hearing threshold >70 dB HL from .25-8kHz, unless subject passes the Tone Audibility Assessment screening with a factor of 1.1
- •Any health or other problems that may prevent the person from completing the study procedures as determined by investigator
- •Participant reports current suicidal ideation and/or homicidal ideation
- •Use of medication which may trigger tinnitus [e.g., quinine derivatives, aminoglycoside antibiotics, daily high dose non-steroidal anti-inflammatory drugs ≥1000 mg, salicylates (when not prescribed as a low dose for cardiac health), loop diuretics and chemotherapy agents like cis-platin]
- •Conductive hearing loss
- •Visible congenital or traumatic deformity of the ear
- •History of active drainage from the ear within the past 90 days
- •History of sudden or rapidly progressive hearing loss within the past 90 days
- •Inability to read and respond appropriately to instructions that appear on the computer screen, and/or to perform all of the procedures
- •Previous use of Desyncra for Tinnitus Therapy System
结局指标
主要结局
Tinnitus Questionnaire (TQ)
时间窗: 24-weeks
52-item questionnaire that measures the functional impact of tinnitus (scores range from 0 to 104); lower scores indicate better outcome
次要结局
未报告次要终点
研究者
Sarah Theodoroff
Research Investigator
VA National Center for Rehabilitative Auditory Research