NCT03726112暂停不适用
A Randomized, Double Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SpotOn Specs for the Treatment of Chronic Dizziness & Imbalance
SpotOn Therapeutics Ltd.2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2018年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Change from Baseline in the Dizziness Handicap Inventory (DHI)
研究概览
简要总结
A Randomized, Double Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SpotOn specs for the Treatment of Chronic Dizziness & Imbalance.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18≤ years ≤70
- •DHI score of at least 36 (moderate to severe handicap)
- •One or more symptoms of unsteadiness, dizziness or vertigo are present on most days. Symptoms could vary in intensity however lasts for 3 months or more
- •Ability to perform all tests (including computerized test) and interviews
- •At least three months after the last Vestibular Balanced Rehabilitation Therapy - (if applicable)
- •Gave informed consent for participation in the study
排除标准
- •Dizziness disease with fluctuating symptoms
- •Any active or non-controlled disease that might cause dizziness and imbalance, unless well controlled for at least 3 months
- •Moderate-Severe Depression or Anxiety
- •Known related eye disease
- •Pregnant women
- •Currently taken part in a clinical trial or within 30 days prior to screening
- •Concomitant use of any medications that might affect the balance system
结局指标
主要结局
Change from Baseline in the Dizziness Handicap Inventory (DHI)
时间窗: baseline, 8 weeks
The Dizziness Handicap Inventory (DHI) is a 25-item self-assessment scale. A "yes" response to an item is awarded 4 points, a "sometimes" 2 points, and a "no", 0 points. Possible scores on the DHI range from 0 (suggesting no handicap) to 100, indicating significant perceived handicap
次要结局
- Change from baseline in Postural sway(baseline, 8 weeks)
- Change from baseline in the Vertigo Symptom Scale-Short Form (VSS-SF)(baseline, 8 weeks)
- Incident rate of falls(8 weeks)
- Change from baseline in the Beck Anxiety Inventory(baseline, 8 weeks)
- Clinical Global Impression of Improvement(8 weeks)
- Change from baseline in the Clinical Global Impression of Severity(baseline, 8 weeks)
- Change from baseline in the Visual Vertigo Analog Scale (VVAS)(baseline, 8 weeks)
研究者
研究点 (2)
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