Population Based Lighting Study on Older Adults

Study Overview
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Brief Summary
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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).

Detailed Description
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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

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

Conditions
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Lightning Strategies on Health, Circadian Rhythms Photoentrainment, Photoentrainment and Sleep, DLMO

Intervention / Treatment
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* Behavioral: indoor light intervention
* Behavioral: no indoor light


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Lack of or inability to provide informed consent Lack of or inability to allow data collection over the course of the study

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: indoor light intervention<br>Persons allocated to the indoor light intervention arm will be given a lamp to be placed at home | Behavioral: indoor light intervention<br>* Persons allocated to the indoor light intervention arm will be given a lamp to be placed at home with specific instructions to install it in a room where they spend most of their time, in order to supplement the existing indoor lighting. Thus, all people of the intervention arm will be equipped with the LUMIE Halo lamp. Utilizing both warm-white and cool-white LEDs, Lumie Halo delivers 10,000 lux at 20 cm at maximum brightness in Day Mode. The touch slider allows the user to adjust the brightness while mixing the color temperature of the light.<br>|
| Active Comparator: control group<br>Persons allocated to the control group will receive no indoor light supplementation and will undergo assessment procedures only | Behavioral: no indoor light<br>* Persons allocated to the control group will receive no indoor light supplementation and will undergo assessment procedures only. Exposure to the outdoor intervention will be taken into account in the analysis in three ways, (1) by locating the distance between people's home and the modified outdoor light, (2) by a question about the awareness of the change in outdoor light, timing, and duration of exposure and what they think of it, and (3) by recording the amount of light exposure over the 24 hours during two weeks at baseline and after the 1-year light interventions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| impact of electric light on sleep quality | 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. | Basal+14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in photoentrainment | Change in photoentrainment as measured by the phase angle between DLMO and sleep onset between the baseline and the end of the light intervention period | from baseline and the end of the light intervention period - 52 weeks | 
| circadian rest-activity measures | Change in circadian rest-activity measures (IS, IV and RA) as well as sleep measures (SE and FI) as derived from actigraphic measurements between the baseline and the end of the light intervention period | from baseline and the end of the light intervention period - 52 weeks | 
| Change in mental and physical health | Change in mental and physical health as measured by validated and self-reported questionnaires between the baseline and the end of the light intervention period | from baseline and the end of the light intervention period - 52 weeks | 
| actigraphic and melatonin assays | Correlation between clinical parameters derived from actigraphic and melatonin assays and the polygenic risk score derived from publicly available summary statistics of Genome-Wide Association Studies (GWAS), as well as the mitochondrial DNA (mtDNA) haplotypes | - 52 weeks |