Population Based Lighting Study on Older Adults

Not Applicable

Recruiting

• Conditions: Circadian Rhythms Photoentrainment; Photoentrainment and Sleep; Lightning Strategies on Health; DLMO
• Interventions: Behavioral: no indoor light; Behavioral: indoor light intervention

• Registration Number: NCT05676086
• Lead Sponsor: Azienda Usl di Bologna

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

Study Timeline

• Study First Submitted: 2022-12-22
• Study First Submitted QC: 2022-12-22
• Study First Posted: 2023-01-09
• Status Verified: 2023-02
• Study Start: 2023-02-01
• Last Update Submitted: 2023-02-24
• Last Update Posted: 2023-02-27
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	no indoor light	Persons allocated to the control group will receive no indoor light supplementation and will undergo assessment procedures only
indoor light intervention	indoor light intervention	Persons allocated to the indoor light intervention arm will be given a lamp to be placed at home

Primary Outcome Measures

Name	Time	Method
impact of electric light on sleep quality	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Irccs - Istituto Delle Scienze Neurologiche; 🇮🇹 Bologna, Italy