NCT04325347已完成不适用
Reducing Awakenings and Increasing Sleep Efficiency With Virtual Reality in Patients Suffering From Diabetic Polyneuropathy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Change in sleep efficiency between experimental and control intervention.
研究概览
简要总结
This study is an experimental single centre study investigating the effect of VR on overall sleep quality and number of awakenings in patients with diabetic polyneuropathy.
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 (Care Provider, 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 between 18 and 70 years old
- •Able to speak Dutch/French
- •Continuing usual care regarding medication use 3 weeks prior and during study participation
- •Diagnosis of DPN for 6 months or longer, confirmed on EMG
排除标准
- •History of seizures/epilepsia
- •Susceptibility to motion sickness or cyber-sickness, susceptibility to claustrophobia
- •shift workers
结局指标
主要结局
Change in sleep efficiency between experimental and control intervention.
时间窗: Evaluated during two time periods of two weeks.
Measured with actigraphy.
Change in number of awakenings during the night between experimental and control intervention.
时间窗: Evaluated during two time periods of two weeks.
Measured with actigraphy.
次要结局
- Change in subjective sleep quality between experimental and control intervention.(Evaluated during two time periods of two weeks.)
- Pain catastrophizing(Evaluated at the end of the experimental and control intervention namely after the two-week periods.)
- Any side effects of the experimental intervention(Evaluated at the end of the experimental intervention namely after the two-week period.)
- Nature, severity and impact of insomnia(Evaluated at the end of the experimental and control intervention namely after the two-week periods.)
- Change in pain intensity reporting between experimental and control intervention.(Evaluated during two time periods of two weeks.)
- Anxiety and depressive symptoms(Evaluated at the end of the experimental and control intervention namely after the two-week periods.)
- Change in clinical status(Evaluated at the end of the experimental and control intervention namely after the two-week periods.)
研究者
Moens Maarten
principal investigator
Universitair Ziekenhuis Brussel
研究点 (2)
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