Pilot Study to Demonstration of Safety and Efficacy of VeSTAL Sleep Device in Human Subjects: Randomized Study of VeSTAL Compared to Sham Control as a Means of Improving Sleep as Determined by ISI Scores
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in Insomnia Severity Index (ISI) Scores
研究概览
简要总结
A randomized, double blind sham controlled clinical trial to evaluate the efficacy of vestibular nerve stimulation (VeNS) compared to a sham control a as a means of improving sleep as measured by ISI scores and EEG recordings
The purpose of this investigation device study is to collect data that will be used to design appropriate pivotal studies that can be used for regulatory submissions, primarily in the United States of America (USA), but it may also be used to support submissions in other regions, including the European Union (EU).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double Blind (Subject, Nursing staff, Co-coordinators, Outcomes Assessor and any other study staff who have contact with the subject)
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both genders
- •Ages 18-24 years inclusive
- •Score above 14 in the insomnia severity index questionnaire
- •Willingness to participate in the study.
排除标准
- •Use sleep medication
- •Ear problems
- •Under any kind of treatment
- •Practicing sleep improving techniques
- •Any other significant health-related problems.
结局指标
主要结局
Change in Insomnia Severity Index (ISI) Scores
时间窗: Day 0, Day 7, Day 14, Day 21, Day 28
ISI scores will be measured during the study and will be compared to baseline readings taken prior to intervention. Insomnia Severity Index scores range from 0 to 28. Scores greater than 15 indicate clinical insomnia.
次要结局
- WHO Quality of Life (WHOQOL) Assessment(Day 0, Day 7, Day 14, Day 21, Day 28)
- EEG Assessment(Day 0, Day 28)
- Depression Anxiety Stress Scales (DASS) Assessment(Day 0, Day 7, Day 14, Day 21, Day 28)