A Randomized, Double Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SpotOn Specs™ for the Treatment of Chronic Dizziness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Dizziness Handicap Inventory (DHI)
研究概览
简要总结
The diagnosis and management of acute vertigo and dizziness is most of the time an easy task for the general practitioner. However, following an acute vestibular disorder and very often with no any overt cause, a considerable number of patients complain on chronic dizziness and subjective disturbance of balance despite normal clinical and laboratory tests. Patients describe that perceptual visual stimulus provoke or aggravate their symptoms that are frequently accompanied by anxiety. These cases have been described in the medical literature as Phobic Postural Vertigo, Visual Vertigo, Chronic Subjective Dizziness and Motion and Space Discomfort (2,3,4,5). Treatment of these conditions includes physical therapy (similar to vestibular rehabilitation exercises) and anti-anxiety or anti-depressant agents such as benzodiazepines and SSRI, however, the effectiveness of these approaches is debatable.
Because visual stimuli play a crucial role in space orientation and motion perception, it is reasonable to hypothesize that certain visual stabilizing signals applied on the peripheral visual field (that is involved mainly in the perception of motion) could be of help in patients suffering from dizziness. This is the rationale of a new technology (SMB- Senso Mental Balance Technology) developed to alleviate the feelings of dizziness.
Trial is conducted in Meir Medical Center, Israel. Recruitment only in Israel!
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18≤ years ≤85
- •Clinical diagnosis of chronic dizziness primary or secondary to vestibular disorder.
- •Stable symptoms for more than one month and less than a year.
- •Ability to perform all tests (including computerized test) and interviews.
- •Gave informed consent for participation in the study.
排除标准
- •Dizziness disease with fluctuating symptoms such as in active Meniere's disease or Benign Paroxysmal Positional Vertigo
- •CNS disease or injuries
- •Dizziness caused as a result of previous whiplash
- •Any active or non-controlled disease that might cause dizziness (e.g. non-controlled diabetes, hypertension, anemia, respiratory, cardiovascular or endocrinological disorder etc.)
- •Pregnant women
- •Participation currently in another clinical study or enrolled in another clinical study within 30 days prior to this study.
研究组 & 干预措施
SpotOn's corrective elements
干预措施: SpotOn's corrective elements for dizziness (Device)
Placebo corrective elements
干预措施: SpotOn's corrective elements for dizziness (Device)
Placebo corrective elements
干预措施: Placebo (Device)
结局指标
主要结局
Dizziness Handicap Inventory (DHI)
时间窗: After 4 weeks of treatment
The change from baseline in dizziness symptoms as measured by Dizziness Handicap Inventory (DHI) The change from baseline in balance as measured by the Activities-specific and Balance Confidence (ABC) Scale. Safety:AE incidence Physical, neuro-otologic and neurological examination Static/dynamic/positioning examination
次要结局
- The Activities-specific Balance Confidence (ABC) Scale(After 4 weeks of treatment)
- Visual Vertigo Analog Scale (VVAS)(After 4 weeks of treatment)
- Vertigo Symptom Scale-Short Form(After 4 weeks of treatment)
- Clinical Global Impressions-Improvement (CGI-I) scale(After 4 weeks of treatment)
- Berg Balance Scale (BBS)(After 4 weeks of treatment)
- Beck Anxiety Inventory (BAI)(After 4 weeks of treatment)
研究者
carlos gordon
Professor, Department of Neurology, Meir Medical Center
Meir Medical Center