Population Based Lighting Study on Older Adults (ENLIGHTENme)

April 30, 2026 updated by: Azienda Usl di Bologna

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

191

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Bologna
      • Bologna, Bologna, Italy, 40139
        • Irccs - Istituto Delle Scienze Neurologiche

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: indoor light intervention
Persons allocated to the indoor light intervention arm will be given a lamp to be placed at home
Behavioral: 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.
Active Comparator: control group
Persons allocated to the control group will receive no indoor light supplementation and will undergo assessment procedures only
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pittsburgh Sleep Quality Index (PSQI)
Time Frame: from baseline to the end of the light intervention period - 16 weeks
Pittsburgh Sleep Quality Index (PSQI) ranges from 0 (better) to 21 (worse). A score <= 5 is associated with good sleep quality, while a score > 5 is associated with poor sleep quality. A higher PSQI 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. Hence, a negative PSQI difference between baseline and follow-up indicates an improvement in sleep quality.
from baseline to the end of the light intervention period - 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mental and Physical Health (Euroqol 5D)
Time Frame: from baseline to the end of the light intervention period - 16 weeks
Change in mental and physical health as measured by Euroqol 5D difference between the baseline and the end of the light intervention period. The Euroqol 5D measures the perceived quality of life and ranges from - 0.57 (worst perceived quality of life) to 1 (best health state). A positive difference from baseline to the end of the follow-up period indicates an improvement in the quality of life.
from baseline to the end of the light intervention period - 16 weeks
Change in Circadian Rest-activity Measures - Interdaily Stability (IS)
Time Frame: from baseline to the end of the light intervention period - 16 weeks

Change in Interdaily Stability (IS), as derived from wrist actigraph, between the baseline and the end of the light intervention period.

Interdaily Stability (IS) is an index that estimates the stability of the 24-hour rest-activity rhythm across days, quantifying how consistent individual's daily pattern is over time. It ranges from 0 (absence of a stable rhythm) to 1 (perfectly stable rhythm). The hypothesis to be tested is that a participant's IS will increase at the end of the light intervention period compared to baseline; hence, a positive difference between baseline and follow-up indicates an improved rest-activity rhythm.
from baseline to the end of the light intervention period - 16 weeks
Change in Circadian Rest-activity Measures - Intradaily Variability (IV)
Time Frame: from baseline to the end of the light intervention period - 16 weeks

Change in Intradaily Variability (IV), as derived from wrist actigraphy, between the baseline and the end of the light intervention period.

Intradaily Variability (IV) is an index that reflects fragmentation of the 24-hour rest-activity rhythm within a day, based on the frequency of transitions between rest and activity. It ranges from 0 to 1, with higher values indicating more fragmented rhythms. The hypothesis to be tested is that a participant's IV will decrease at the end of the light intervention period compared to baseline; hence, a negative difference between baseline and follow-up indicates an improved rest-activity rhythm.
from baseline to the end of the light intervention period - 16 weeks
Change in Circadian Rest-activity Measures - Relative Amplitude (RA)
Time Frame: from baseline to the end of the light intervention period - 16 weeks

Change in Relative amplitude (RA), as derived from wrist actigraphy, between the baseline and the end of the light intervention period.

Relative Amplitude (RA) measures the strength of the 24-hour rhythm: (M10-L5)/(M10+L5). M10 is the mean activity during the 10 most active consecutive hours, and L5 during the 5 least active hours. RA ranges from 0 to 1 and reflects the normalized difference between the most active and least active periods of the day: higher values indicate a well-defined rhythm, lower values a weaker or disrupted rhythm. The hypothesis to be tested is that a participant's RA will increase at the end of the light intervention period compared to baseline; hence, a positive difference between baseline and follow-up indicates an improved rest-activity rhythm.
from baseline to the end of the light intervention period - 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Usl di Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Actual)

February 8, 2024

Study Completion (Actual)

February 8, 2024

Study Registration Dates

First Submitted

December 22, 2022

First Submitted That Met QC Criteria

December 22, 2022

First Posted (Actual)

January 9, 2023

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 467-2022-SPER-AUSLBO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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