Lightning Strategies on HealthENLIGHTENmeNCT05676086
Population Based Lighting Study on Older Adults
A study testing indoor light intervention and no indoor light in people with Lightning Strategies on Health and Circadian Rhythms Photoentrainment, run by Azienda Usl di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Lightning Strategies on Health, Circadian Rhythms Photoentrainment, Photoentrainment and Sleep
- What is being tested?
- indoor light intervention and no indoor light
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2023to 8 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Lack of or inability to provide informed consent
- Lack of or inability to allow data collection over the course of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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
- Conditions
- Lightning Strategies on Health, Circadian Rhythms Photoentrainment, Photoentrainment and Sleep, DLMO
- Being tested
- indoor light intervention, no indoor light
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indoor light interventionBehavioural
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.
no indoor lightBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| indoor light intervention | Experimental | Persons allocated to the indoor light intervention arm will be given a lamp to be placed at home Receives: Behavioral: indoor light intervention |
| control group | Active comparator | Persons allocated to the control group will receive no indoor light supplementation and will undergo assessment procedures only Receives: Behavioral: no indoor light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pittsburgh Sleep Quality Index (PSQI)
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.
Measured: from baseline to the end of the light intervention period - 16 weeks
Secondary outcomes (4)
Change in Mental and Physical Health (Euroqol 5D)
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.
Measured: from baseline to the end of the light intervention period - 16 weeks
Change in Circadian Rest-activity Measures - Interdaily Stability (IS)
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.
Measured: from baseline to the end of the light intervention period - 16 weeks
Change in Circadian Rest-activity Measures - Intradaily Variability (IV)
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.
Measured: from baseline to the end of the light intervention period - 16 weeks
Change in Circadian Rest-activity Measures - Relative Amplitude (RA)
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.
Measured: from baseline to the end of the light intervention period - 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start1 Feb 2023
- Primary completion8 Feb 2024
- Study completion8 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lightning Strategies on HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Usl di Bologna
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676086
- Sponsor's protocol ID
- 467-2022-SPER-AUSLBO
- Acronym
- ENLIGHTENme
- Status last verified
- Feb 2025
- First submitted
- 22 Dec 2022
- Last updated
- 26 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Policies for Improving Citizens' Health and Wellbeing Addressing Indoor and Outdoor Lighting
- ClinicalTrials.gov ID
- NCT05676086
- Acronym / sponsor ID
- ENLIGHTENme / 467-2022-SPER-AUSLBO
- Conditions
- Lightning Strategies on Health, Circadian Rhythms Photoentrainment, Photoentrainment and Sleep, DLMO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Azienda Usl di BolognaOther government
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 8 Feb 2024 (actual)
- Study completion
- 8 Feb 2024 (actual)
- First posted
- 9 Jan 2023 (actual)
- Results
- Posted 26 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| indoor light intervention | Experimental | Behavioral: indoor light interventionPersons allocated to the indoor light intervention arm will be given a lamp to be placed at home |
| control group | Active comparator | Behavioral: no indoor lightPersons allocated to the control group will receive no indoor light supplementation and will undergo assessment procedures only |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Lack of or inability to provide informed consent
- Lack of or inability to allow data collection over the course of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| indoor light interventionPersons 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. | Behavioural | indoor light intervention |
| no indoor lightPersons 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 | Behavioural | control group |
Primary outcome
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.
4 secondary outcomes
Change in Mental and Physical Health (Euroqol 5D)
Time frame: 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 Circadian Rest-activity Measures - Intradaily Variability (IV)
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing indoor light intervention and no indoor light in people with Lightning Strategies on Health and Circadian Rhythms Photoentrainment, run by Azienda Usl di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pittsburgh Sleep Quality Index (PSQI) (time frame: from baseline to the end of the light intervention period - 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.