Combined Auditory-Somatosensory Stimulation to Alleviate Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change in TFI (Tinnitus Functional Index) After Treatment or Sham Compared to Baseline
研究概览
简要总结
The purpose of this study is to develop and test a subject operated device to lessen tinnitus (ringing in the ear), based on subject-feedback for stimulus presentation.
详细描述
This study consented 35 adult subjects. 21 subjects qualified and were randomized into the study. This project will develop and test a device with the ultimate goal of providing a patient operated device to alleviate phantom sound perception, or tinnitus, based on patient-feedback for stimulus presentation.
The device, an electrical-acoustical stimulus timing, is based on physiological findings of stimulus-timing-dependent plasticity in somatosensory and auditory nuclei,that when aberrant, contribute to tinnitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Constant, subjective, preferably unilateral tinnitus without any active external or middle ear pathology.
- •Hearing thresholds better than 50dB HL at peak tinnitus frequencies.
- •Able to modulate their tinnitus with a somatic maneuver
- •BothersomeTinnitus.
排除标准
- •No participation in a tinnitus treatment regimen within the past four weeks
- •Retrocochlear pathology/ VIIIth nerve lesion
研究组 & 干预措施
Sham 1st (Auditory only) then Active (Bimodal)
To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab.
During active treatment, the device will deliver electric somatosensory and auditory stimulation.
干预措施: Sham Treatment: unimodal auditory stimulation (Device)
Sham 1st (Auditory only) then Active (Bimodal)
To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab.
During active treatment, the device will deliver electric somatosensory and auditory stimulation.
干预措施: Active Treatment: Bimodal auditory-somatosensory stimulation (Device)
Active (Bimodal) then Sham (Auditory only)
During active treatment, the device will deliver electric somatosensory and auditory stimulation.
To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab.
干预措施: Sham Treatment: unimodal auditory stimulation (Device)
Active (Bimodal) then Sham (Auditory only)
During active treatment, the device will deliver electric somatosensory and auditory stimulation.
To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab.
干预措施: Active Treatment: Bimodal auditory-somatosensory stimulation (Device)
结局指标
主要结局
Change in TFI (Tinnitus Functional Index) After Treatment or Sham Compared to Baseline
时间窗: Four weeks on treatment (or sham)
Change in TFI score (mean of weekly assessments for 4 weeks) from baseline for treatment and sham groups. TFI is a clinical questionnaire that assesses tinnitus impact on a subject's quality of life. It uses a scale of 0 - 100 where 0 means no negative impact on quality of life from tinnitus and 100 is devastating impact It will be administered weekly through out the study.
Change in Tinnitus Loudness as Assessed by TinnTester
时间窗: 4 weeks on treatment (or sham)
Change in Tinnitus matching loudness score (mean of weekly assessments for 4 weeks) from baseline tinnitus matching loudness score, for treatment and sham groups. Subjects are guided through a self-directed computerized assessment software that estimates how loud (in decibels) they perceive their tinnitus to be (TinnTester). This measure was performed at baseline, as well as time points following active, washout, or sham periods.
次要结局
未报告次要终点
研究者
Susan E. Shore
Professor, Otolaryngology, Molecular and Integrative Physiology; Professor, Biomedical Engineering Kresge Hearing Research Institute The Joseph Hawkins Collegiate Research Professor
University of Michigan