NCT02669069已完成不适用
Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)
Neuromod Devices Ltd.2 个研究点 分布在 2 个国家目标入组 326 人开始时间: 2016年6月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 326
- 试验地点
- 2
- 主要终点
- Tinnitus Functional Index
研究概览
简要总结
This is a three arm, patient subtyping and parameter optimisation study for a neuromodulation treatment for tinnitus.
详细描述
Participants with chronic tinnitus will be provided with a CE marked neuromodulation device. Devices will be programmed with one of 3 stimulation parameter settings. After 12 weeks of use, differences in tinnitus severity scores will be compared between the 3 arms and within the arms for patient subtype analysis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 70 years of age
- •The ability to read and understand English/German
- •Willing and able to provide informed consent
- •Willing to commit to the full duration of the study
- •Have been experiencing tinnitus 3 months to 5 years
- •Experiencing subjective tinnitus
- •Baseline Tinnitus Handicap Inventory (THI) score of 28 to 76 points
- •Baseline Minimum Masking Level (MML) of 20 to 80 dBHL
- •Maximum AC pure-tone audiometry hearing loss of 80 dB HL at any test frequency in the range of 2 to 8 kHz or of 40 dB HL in the range of 250 to 1000 Hz either unilaterally or bi-laterally
排除标准
- •If participant has been diagnosed with objective tinnitus
- •Commenced usage of hearing aid within the last 90 days
- •Cases where pulsatility is the dominant feature of tinnitus
- •Patients whose tinnitus cannot be masked during MML assessment
- •Meniere's disease
- •Significantly severe Loudness Discomfort Level (LDL), <30 dB SL
- •Depression or neuro-psychological condition, previously diagnosed or identified from the State-Trait Anxiety Inventory (STAI) scores greater than 120
- •Diagnosed with somatic tinnitus resulting from head or neck injury
- •Temporomandibular Joint Disorder (TMJ)
- •Current or previous involvement in medico-legal cases
- •Pregnancy
- •Oral piercings
- •Neurological conditions that may lead to loss of consciousness (e.g. epilepsy) or is considered to be the dominant feature of the tinnitus, as assessed by audiologist or ENT consultant
- •Severe cognitive impairment based on Mini Mental State Examination (MMSE), less than 20
- •Pacemakers or other electro-active implanted devices
- •Have used Neuromod Devices products in the past
- •Participants currently prescribed drugs for a Central Nervous System pathology, i.e. epilepsy, Multiple Sclerosis (MS), Parkinson's, bi-polar disorder.
- •The site Principal Investigator does not deem the candidate to be suitable for the study for other reasons not listed above
- •Self-reporting episodes of Auditory hallucinations
- •Abnormal Otoscopy as assessed by the Audiologist, including active Otitis Media, perforation and hearing loss that is identified as completely conductive
- •Abnormal Tympanometry as assessed by the Audiologist
结局指标
主要结局
Tinnitus Functional Index
时间窗: Between baseline and 12 weeks
Tinnitus Handicap Inventory
时间窗: Between baseline and 12 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
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