Population Based Lighting Study on Older Adults

NCT ID: NCT05676086

Last Updated: 2023-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2023-12-31

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

Conditions

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Lightning Strategies on Health Circadian Rhythms Photoentrainment Photoentrainment and Sleep DLMO

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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indoor light intervention

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

Group Type EXPERIMENTAL

indoor light intervention

Intervention Type BEHAVIORAL

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.

control group

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

Group Type ACTIVE_COMPARATOR

no indoor light

Intervention Type BEHAVIORAL

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

Interventions

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indoor light intervention

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.

Intervention Type BEHAVIORAL

no indoor light

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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Usl di Bologna

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Irccs - Istituto Delle Scienze Neurologiche

Bologna, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Francesco Nonino

Role: primary

051 6225295

Other Identifiers

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467-2022-SPER-AUSLBO

Identifier Type: -

Identifier Source: org_study_id

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