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临床试验/NCT05676086
NCT05676086已完成不适用

Innovative Policies for Improving Citizens' Health and Wellbeing Addressing Indoor and Outdoor Lighting

Azienda Usl di Bologna2 个研究点 分布在 1 个国家目标入组 191 人开始时间: 2023年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
191
试验地点
2
主要终点
impact of electric light on sleep quality

研究概览

简要总结

The ENLIGHTENme project aims at collecting evidence about the impact of outdoor and indoor lighting on human health and wellbeing through the development and testing of innovative solutions and policies that will also counteract health inequalities in European cities. In particular, through an open-online Urban Lighting and Health Atlas, ENLIGHTENme will collect and systematize existing data and good practices on urban lighting and will perform an accurate analysis on the correlations among health, wellbeing, lighting and socio-economic factors in three pilot cities: Bologna (Italy), Amsterdam (The Netherlands), and Tartu (Estonia).

详细描述

The ENLIGHTENme project aims at collecting evidence about the impact of outdoor and indoor lighting on human health and wellbeing through the development and testing of innovative solutions and policies that will also counteract health inequalities in European cities. In particular, through an open-online Urban Lighting and Health Atlas, ENLIGHTENme will collect and systematize existing data and good practices on urban lighting and will perform an accurate analysis on the correlations among health, wellbeing, lighting and socio-economic factors in three pilot cities: Bologna (Italy), Amsterdam (The Netherlands), and Tartu (Estonia).

In this context, the ENLIGHTENme project will also include an interventional, multicenter, prospective, randomized, controlled, unblinded trial involving one target district, selected based on its artificial light characteristics, in the urban areas of each of one of the three pilot cities. Within each target district, a random sample of individuals aged 65 years or older (intervention group) will be exposed to modifications in domestic indoor lighting and compared with a control group, living in the same target district, unexposed to domestic electric light modifications. At the same time, in a specific area of the target district, outdoor lighting will be modified by the local municipal authority. The hypothesis to be tested in this study is that light interventions may improve individual physical and mental health by affecting circadian entrainment, sleep pattern, and mood. Thus, the study is aimed at providing evidence whether the planned change in electric light exposure at both urban public outdoor and domestic indoor lighting levels may impact on physical and mental health by improving photo-entrainment of circadian rhythms to the light-dark cycle

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Living in the three selected cities within the target district chosen for the study
  • Women and men
  • Age 65 years or older
  • Signing informed consent

排除标准

  • Lack of or inability to provide informed consent
  • Lack of or inability to allow data collection over the course of the study

研究组 & 干预措施

indoor light intervention

Experimental

Persons allocated to the indoor light intervention arm will be given a lamp to be placed at home

干预措施: indoor light intervention (Behavioral)

control group

Active Comparator

Persons allocated to the control group will receive no indoor light supplementation and will undergo assessment procedures only

干预措施: no indoor light (Behavioral)

结局指标

主要结局

impact of electric light on sleep quality

时间窗: Basal+14 days

to evaluate the impact of electric light on sleep quality as measured with the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-reported questionnaire that measures sleep quality over the previous month. A higher 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.

次要结局

  • Change in photoentrainment(from baseline and the end of the light intervention period - 52 weeks)
  • Change in mental and physical health(from baseline and the end of the light intervention period - 52 weeks)
  • actigraphic and melatonin assays(- 52 weeks)
  • circadian rest-activity measures(from baseline and the end of the light intervention period - 52 weeks)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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