基于人群的老年人照明研究 (ENLIGHTENme)
改善公民健康和福祉的创新政策解决室内和室外照明问题
研究概览
详细说明
ENLIGHTENme 项目旨在通过开发和测试创新解决方案和政策来收集室外和室内照明对人类健康和福祉影响的证据,这些解决方案和政策也将抵消欧洲城市的健康不平等现象。 特别是,通过开放的在线城市照明和健康地图集,ENLIGHTENme 将收集和系统化有关城市照明的现有数据和良好实践,并将在三个试点项目中对健康、福祉、照明和社会经济因素之间的相关性进行准确分析城市:博洛尼亚(意大利)、阿姆斯特丹(荷兰)和塔尔图(爱沙尼亚)。
在此背景下,ENLIGHTENme 项目还将包括一项干预性、多中心、前瞻性、随机、对照、非盲法试验,涉及一个目标地区,该地区根据其人造光特性选择,在三个试点城市中的每一个的城市地区进行。 在每个目标区域内,将随机抽取 65 岁或以上的个人样本(干预组)进行室内室内照明改造,并与居住在同一目标区域内、未进行家用电灯改造的对照组进行比较。 同时,在目标区域的特定区域,室外照明将由当地市政当局进行改造。 本研究要检验的假设是,光照干预可以通过影响昼夜节律、睡眠模式和情绪来改善个人的身心健康。 因此,该研究旨在提供证据,证明计划改变城市公共室外和家庭室内照明水平的电光暴露是否会通过改善昼夜节律对光暗循环的光夹带来影响身心健康
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Bologna
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Bologna、Bologna、意大利、40139
- Irccs - Istituto Delle Scienze Neurologiche
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准:
- 居住在为研究选择的目标地区内的三个选定城市
- 女人和男人
- 65岁或以上
- 签署知情同意书
排除标准:
- 缺乏或无法提供知情同意
- 在研究过程中缺乏或无法收集数据
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:室内光干预
分配到室内光干预组的人员将获得一盏灯放在家里
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分配到室内光干预组的人员将获得一盏灯,让他们在家中放置,并附有具体说明,将其安装在他们大部分时间待的房间内,以补充现有的室内照明。
因此,干预臂的所有人都将配备 LUMIE Halo 灯。
Lumie Halo 同时使用暖白光和冷白光 LED,在“白天”模式下以最大亮度在 20 厘米处提供 10,000 勒克斯。
触摸滑块允许用户在混合光色温的同时调整亮度。
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有源比较器:控制组
分配到对照组的人员将不接受室内补光,仅进行评估程序
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分配到对照组的人员将不接受室内补光,仅接受评估程序。
在分析中将通过三种方式考虑对室外干预的暴露,(1) 通过定位人们的家与修改后的室外光之间的距离,(2) 通过一个关于室外光变化的意识的问题,时间,以及暴露的持续时间和他们的想法,以及 (3) 通过记录基线和 1 年光照干预后两周内 24 小时内的光照量
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Pittsburgh Sleep Quality Index (PSQI)
大体时间:from baseline to the end of the light intervention period - 16 weeks
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Pittsburgh Sleep Quality Index (PSQI) ranges from 0 (better) to 21 (worse).
A score <= 5 is associated with good sleep quality, while a score > 5 is associated with poor sleep quality.
A higher PSQI score indicates poorer sleep quality, therefore the hypothesis to be tested is that a participant's sleep quality will improve (i.e.
PSQI score will decrease) at the end of the light intervention period compared to baseline.
Hence, a negative PSQI difference between baseline and follow-up indicates an improvement in sleep quality.
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from baseline to the end of the light intervention period - 16 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Mental and Physical Health (Euroqol 5D)
大体时间:from baseline to the end of the light intervention period - 16 weeks
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Change in mental and physical health as measured by Euroqol 5D difference between the baseline and the end of the light intervention period.
The Euroqol 5D measures the perceived quality of life and ranges from - 0.57 (worst perceived quality of life) to 1 (best health state).
A positive difference from baseline to the end of the follow-up period indicates an improvement in the quality of life.
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from baseline to the end of the light intervention period - 16 weeks
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Change in Circadian Rest-activity Measures - Interdaily Stability (IS)
大体时间:from baseline to the end of the light intervention period - 16 weeks
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Change in Interdaily Stability (IS), as derived from wrist actigraph, between the baseline and the end of the light intervention period. Interdaily Stability (IS) is an index that estimates the stability of the 24-hour rest-activity rhythm across days, quantifying how consistent individual's daily pattern is over time. It ranges from 0 (absence of a stable rhythm) to 1 (perfectly stable rhythm). The hypothesis to be tested is that a participant's IS will increase at the end of the light intervention period compared to baseline; hence, a positive difference between baseline and follow-up indicates an improved rest-activity rhythm. |
from baseline to the end of the light intervention period - 16 weeks
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Change in Circadian Rest-activity Measures - Intradaily Variability (IV)
大体时间:from baseline to the end of the light intervention period - 16 weeks
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Change in Intradaily Variability (IV), as derived from wrist actigraphy, between the baseline and the end of the light intervention period. Intradaily Variability (IV) is an index that reflects fragmentation of the 24-hour rest-activity rhythm within a day, based on the frequency of transitions between rest and activity. It ranges from 0 to 1, with higher values indicating more fragmented rhythms. The hypothesis to be tested is that a participant's IV will decrease at the end of the light intervention period compared to baseline; hence, a negative difference between baseline and follow-up indicates an improved rest-activity rhythm. |
from baseline to the end of the light intervention period - 16 weeks
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Change in Circadian Rest-activity Measures - Relative Amplitude (RA)
大体时间:from baseline to the end of the light intervention period - 16 weeks
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Change in Relative amplitude (RA), as derived from wrist actigraphy, between the baseline and the end of the light intervention period. Relative Amplitude (RA) measures the strength of the 24-hour rhythm: (M10-L5)/(M10+L5). M10 is the mean activity during the 10 most active consecutive hours, and L5 during the 5 least active hours. RA ranges from 0 to 1 and reflects the normalized difference between the most active and least active periods of the day: higher values indicate a well-defined rhythm, lower values a weaker or disrupted rhythm. The hypothesis to be tested is that a participant's RA will increase at the end of the light intervention period compared to baseline; hence, a positive difference between baseline and follow-up indicates an improved rest-activity rhythm. |
from baseline to the end of the light intervention period - 16 weeks
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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