Quantification of the Effect of the OtoBand, a Non-invasive Vestibular Masker, on Objective Measures of Vertigo and Dizziness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Determine change in objective measures of vestibular symptoms, namely change in VOR Gain induced by the OtoBand.
研究概览
简要总结
Vestibular disorders are among the most common causes of disability in society and affect over 50% of the population over the age of 65 and a significant percentage of the younger population. Vestibular disorders have a dramatic impact on daily life impacting work, relationships, and even activities of daily living.The OtoBand has shown promise and might be beneficial for treating or improving the course of recovery from vestibular disorders.
This study seeks to quantify the effect of the study device, the OtoBand, on objective measures of dizziness and vertigo in patients with vestibular dysfunction.
The study will be conducted at a single-site and will be a blinded, randomized, placebo-controlled design in which participants do not know if they are receiving bone conducted stimulation 1) at a therapeutic level or 2) at a non therapeutic level.
详细描述
Vestibular disorders are among the most common causes of disability in society and affect over 50% of the population over the age of 65 and a significant percentage of the younger population. Vestibular disorders have a dramatic impact on daily life impacting work, relationships, and even activities of daily living. At the current time, the mainstay of therapy for many vestibular disorders is a physical therapy called vestibular rehabilitation. While usually highly effective, this therapy is time consuming and not universally effective, in part because of inconsistent subject compliance. The use of adjuvant devices to speed recovery has been studied but very few devices have proved beneficial; the few that have shown benefit only work in special populations and are large units that cost several million dollars.
In this study, the investigators will assay the efficacy of the OtoBand in participants with vertigo and dizziness. The OtoBand will be given to participants with vertigo and dizziness in patients with vestibular dysfunction. Participants will be recruited from patients who present at the Dizziness and Vertigo Institute of Los Angeles and for whom the Principal Investigators recommend a course of vestibular rehabilitation therapy. The OtoBand will be set at either a normal power (effective) or low power (lower than the power level thought to be effective, placebo device). Participants will not know if they are receiving receiving bone conducted stimulation 1) at a therapeutic level or 2) at a non therapeutic level.
This study seeks to determine if, in patients going to the Dizzy and Vertigo Institute of Los Angeles for vestibular rehabilitation therapy, objective measures of dizziness and vertigo are significantly changed by wearing the OtoBand.
Potential changes will be measured in the following tests:
- Subjective Visual Vertical (SVV),
- Sinusoidal Harmonic Acceleration (SHA), also known as rotary chair test
- Spontaneous Nystagmus
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants with vertigo and dizziness will be asked to participate in the study. Subjects that give consent will be entered into the study and three conditions (sham, therapeutic and no device) will be tested within an hour in a randomized sequence, with the OtoBand remaining in place throughout (turned off in the "no device" condition). The subjects will complete a Participant Questionnaire following the testing.
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
- •Vertigo that has been present for at least 90 days, constant or predictable with attacks at least twice a week.
- •Classified as having vertigo from one of the following vestibulogenic vertigo conditions:
- •Migraine Associated Vertigo, aka Vestibular Migraine
- •Chronic Unilateral Vestibulopathy in one of three forms: Persistent Postural-Perceptual Dizziness (aka 3PD), Vestibular Neuritis, Labyrinthitis
- •Score > 35 on Dizziness Handicap Inventory
- •Willingness to cease vestibular suppressants for 24h prior to study.
排除标准
- •Vertigo that first presented within the last 90 days
- •Skull base surgery within the last 90 days
- •Any skull implant (cochlear implant, bone conduction implant, DBS)
- •Resolved vestibular dysfunction by the time of study appointment
- •History of head injury within the last 6 months or currently suffering the effects of a head injury
- •History of diagnosed untreated neuropsychiatric disorders (hypochondriasis, major depression, schizophrenia)
- •Prior documented neurodegenerative disorders of hearing and balance including:
- •Multiple sclerosis
- •Vestibular schwannoma
- •History of Cerebrovascular disorders
- •History of ear operation other than myringotomy (tube placement)
- •Vitreous detachment of the retina (floaters) in the previous 90 days
- •Presence of severe aphasia, and individuals who cannot provide informed consent
结局指标
主要结局
Determine change in objective measures of vestibular symptoms, namely change in VOR Gain induced by the OtoBand.
时间窗: Within 60 minute trial period.
We measure the Gain of the Vestibular Ocular Reflex (VOR) associated with sinusoidal harmonic accelerations (SHAs) at multiple frequencies of rotation. The mean Gain across all frequencies will be computed for each three experimental conditions (OtoBand/sham/no device). The quantifiable outcome will be the deviation from nominal values of the Gain as a function of experimental condition.
Determine change in objective measures of vestibular symptoms, namely change in VOR Phase induced by the OtoBand.
时间窗: Within 60 minute trial period.
We measure the Phase of the Vestibular Ocular Reflex (VOR) associated with sinusoidal harmonic accelerations (SHAs) at multiple frequencies of rotation. The mean phase lag across all frequencies will be computed for each three experimental conditions (OtoBand/sham/no device). The quantifiable outcome will be the deviation from nominal values of the phase lag as a function of experimental condition.
次要结局
- Measure whether Vestibular Migraine and Vestibulopathy patients experience higher benefits from a low vs high bone conduction levels as measured by outcomes of objective tests (SHAs and spontaneous nystagmus)(Within 60 minute trial period.)
- Determine change in objective measures of vestibular symptoms, namely change in residual nystagmus following SHAs, as a function of experimental condition.(Within 60 minute trial period.)
- Participant's questionnaire as to which power level they believe were sham setting vs therapeutic setting(Within 60 minute trial period.)