A Randomized Controlled Trial of Air Purifier to Improve Endothelial Function and Carotid Intima Thickness in Older Diabetic People With Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- FMD%
研究概览
简要总结
Background: There is epidemiological evidence or link ambient air pollution exposure to the incidence of dementia.
Aims or hypotheses: It is hypothesized that reduction in indoor pollutants from air purification improves endothelial function and carotid intima thickness in older diabetic people with cognitive impairment.
Subjects and method: People with clinically diagnosis mild cognitive impairment or early dementia will be recruited. After obtaining written consent, the subjects will be assessed cognitive function and arterial health. After baseline measurements, the subjects are randomly assigned to have either filter or no filter installed in the air purifier. The air purifier will be placed in living room of the household of the subject for one year. At one year, the measurements will be repeated.
Statistical analysis: Intention to treat analysis will be adopted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetic people
- •Mild cognitive impairment or early dementia
排除标准
- •Current smoker
- •The presence of a smoker in the household
- •The absence of a reliable family caregiver
- •The lack of mental capacity to give informed consent
结局指标
主要结局
FMD%
时间窗: 12 months
Endothelial function will be assessed by Flow mediated dilatation of brachial artery
次要结局
未报告次要终点
研究者
Timothy Kwok
Professor
Chinese University of Hong Kong