NCT03530306已完成不适用
Treatment Evaluation of Neuromodulation for Tinnitus - Stage A2 (TENT-A2)
Neuromod Devices Ltd.1 个研究点 分布在 1 个国家目标入组 191 人开始时间: 2018年3月20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
- 191
- 试验地点
- 1
- 主要终点
- Tinnitus Handicap Inventory (THI)
研究概览
简要总结
This is a four 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. Participants are randomized to one of four different treatment arms. The treatment period is intended for 12 weeks of use. Based on the clinical investigation plan, participants are informed that their stimulation settings can change between the first and second halves of the treatment period and that the differences may be perceptually noticeable. Differences in tinnitus severity scores will be compared between and within treatment arms.
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, Care Provider, Investigator)
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
- •Ability to read and understand English
- •Willing and able to provide informed consent
- •Willing to commit to the full duration of the study
- •Baseline Tinnitus Handicap Inventory (THI) score of >= 38 points
- •Subjective tinnitus of 3 months to 10 years
- •Maximum AC pure-tone audiometry hearing loss of 80 dB HL in any test frequency in the set {2,3,4,6,8}kHz or 40 dB HL in the set {250,500,1000}Hz either unilaterally or bilaterally
- •Baseline Minimum Masking Level (MML) of 20 to 80 dB HL
- •Tonal tinnitus
排除标准
- •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 Minimum Masking Level (MML) assessment
- •Meniere's disease
- •Significantly severe Loudness Discomfort Level (LDL, less than 30 dB SL)
- •Depression or neuro-psychological condition, previously diagnosed or identified from the State-Trait Anxiety Inventory (STAI) with score 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 condition 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)
- •Patient with a pacemaker or other electro-active implanted device
- •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 Handicap Inventory (THI)
时间窗: Between-arm and within-arm changes in THI after 6 weeks of treatment
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)TinnitusNCT02669069Neuromod Devices Ltd.326
已完成
不适用
Treatment Evaluation of Neuromodulation for Tinnitus - Stage A3TinnitusNCT05227365Neuromod Devices Ltd.112
已完成
不适用
Clinical Utility of Neuromodulation on TinnitusTinnitusNCT05674435Hearing and Language Healthcare Center, China Medical University Hsinchu Hospital, Taiwan26
Unknown
4 期
Customized Acoustic Stimulation for Long Term Medical Benefit for the Relief of Tinnitus and HyperacusisHyperacusisTinnitusNCT00730834Neuromonics, Inc.53
已完成
不适用
Sensory Neuromodulation Protocol for the Treatment of Post-stroke Oropharyngeal Dysphagia.Swallowing DisorderDysphagiaNeurophysiologic AbnormalityStrokeNCT04052178Hospital de Mataró36