Clinical trial NCT05676086: Population Based Lighting Study on Older Adults
Official title: Innovative Policies for Improving Citizens' Health and Wellbeing Addressing Indoor and Outdoor Lighting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lightning Strategies on Health
Circadian Rhythms Photoentrainment
Photoentrainment and Sleep
DLMO
Lead sponsor: Azienda Usl di Bologna
Sponsor class: OTHER_GOV
First posted: 2023-01-09
Enrollment: 600
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: impact of electric light on sleep quality
timeFrame: Basal+14 days
Secondary outcomes:
measure: Change in photoentrainment
timeFrame: from baseline and the end of the light intervention period - 52 weeks
measure: circadian rest-activity measures
timeFrame: from baseline and the end of the light intervention period - 52 weeks
measure: Change in mental and physical health
timeFrame: from baseline and the end of the light intervention period - 52 weeks
measure: actigraphic and melatonin assays
timeFrame: - 52 weeks
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Irccs - Istituto Delle Scienze Neurologiche
Study officials:
References: