NCT07158034进行中（未招募）不适用
Investigating EEG as a Biomarker for Tinnitus Improvement After Bimodal Stimulation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in brain waves at 6 weeks
研究概览
简要总结
The aim of the proposed study is to investigate the use of resting-state Electroencephalogram (EEG)-Based Brain Entropy (EBDBE) and auditory brainstem responses (ABR) as an objective measure of tinnitus improvement following the use of a bimodal stimulation device in individuals with tinnitus after six weeks of bi-modal stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Treatment Group Inclusion Criteria:
- •18 years and over at time of consent
- •Ability to read and understand English
- •Willing and able to provide and understand informed consent
- •Willing to commit to the full duration of the investigation
- •Subjective tinnitus
- •Tinnitus duration of greater than or equal to 3 months and less than or equal to 20 years at time of consent (only for participants in treatment group)
- •Baseline THI score from 40 to 76 (only for participants in treatment group)
- •Hearing loss condition - can hear the acoustic stimulation of the Lenire device (only for participants in treatment group)
- •Treatment Group
排除标准
- •Subjective tinnitus, where pulsatility is the dominant feature (only for participants in treatment group)
- •Objective tinnitus
- •Can't hear acoustic stimulation of the Lenire device within its mid- range volume setting
- •Began wearing hearing aids within the past 3 months
- •A healthcare provider has diagnosed Meniere's disease or another disorder associated with fluctuating hearing loss.
- •History of auditory hallucinations
- •Tumor on the hearing or balance nervous systems
- •Hospitalization, or visit to a physician, for a head or neck injury, including whiplash, in the previous 12 months
- •Initiated new prescription medications or medical treatments in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics.
- •Ceased prescription medications or medical treatments in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics.
- •Changed dosage of prescription medications in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics.
- •Any use of benzodiazepines or sedative hypnotics (either regularly or on demand)
- •Neurological condition that may lead to seizures or loss of consciousness (e.g., epilepsy)
- •Participant with a pacemaker or other electro-active implanted device
- •Participant previously diagnosed with psychosis or schizophrenia
- •Participants diagnosed with Burning Mouth Syndrome
- •A diagnosis of bothersome temporomandibular joint disorder (TMJ) has been rendered
- •Previous involvement in a clinical investigation for tinnitus treatment or had an implantable or surgical intervention for tinnitus
- •Inability to physically or comprehensively use the device
- •Oral piercings that cannot or will not be removed
- •Pregnancy per patient report
- •PI does not deem the candidate to be suitable for the investigation for other reasons not listed above. Rationale must be provided.
- •Control Group Inclusion Criteria:
- •18 years and over at time of consent
- •Ability to read and understand English
- •Willing and able to provide and understand informed consent
- •Willing to commit to the full duration of the investigation
- •Control Group Exclusion Criteria:
- •Began wearing hearing aids within the past 3 months
- •Hospitalization, or visit to a physician, for a head or neck injury, including whiplash, in the previous 12 months
- •Initiated new prescription medications or medical treatments in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics.
- •Ceased prescription medications or medical treatments in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics.
- •Changed dosage of prescription medications in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics.
- •Any use of benzodiazepines or sedative hypnotics (either regularly or on demand)
- •Neurological condition that may lead to seizures or loss of consciousness (e.g., epilepsy)
- •Participant previously diagnosed with psychosis or schizophrenia
- •A diagnosis of bothersome temporomandibular joint disorder (TMJ) has been rendered
- •PI does not deem the candidate to be suitable for the investigation for other reasons not listed above. Rationale must be provided.
研究组 & 干预措施
Control Group
No Intervention
Participants in the control group will not receive the stimulation device and will not undergo any stimulation during the study.
Treatment Group
Experimental
Use Lenire device for 1 hour daily
干预措施: Lenire Device (Device)
结局指标
主要结局
Change in brain waves at 6 weeks
时间窗: Week 6
Assessed via 32-channel EEG recording
次要结局
- Correlation between change in EBDBE, ABR, THI, and PSS-10(Week 6)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Objective Diagnosis Method and Efficacy of Repetitive Transcranial Magnetic Stimulation as a Treatment for TinnitusTinnitusNCT02617953Seoul National University Hospital80
Unknown
不适用
Tinnitus Measured by MEG and Synchronous Neural Interaction™ Test: Template DevelopmentTinnitusNCT01185990Orasi Medical, Inc.45
已完成
不适用
Visualizing tinnitus with EEG.ringing in the ears1002766710029305NL-OMON35893niversiteit Twente75
已完成
不适用
fMRI Tracking taVNS in ASDAutistic Spectrum DisordersNCT06698328Medical University of South Carolina16
招募中
不适用
Cohort Study on Biomarkers and Clinical Treatment of TinnitusTranscranial Magnetic Stimulation, RepetitiveTinnitus, SubjectiveAcoustic StimulationMagnetoencephalographyNCT05871294Zhiwu Huang, Ph.D.40