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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).
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| indoor light intervention | Experimental | Persons allocated to the indoor light intervention arm will be given a lamp to be placed at home |
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| control group | Active Comparator | Persons allocated to the control group will receive no indoor light supplementation and will undergo assessment procedures only |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| indoor light intervention | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from baseline to the end of the light intervention period - 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Irccs - Istituto Delle Scienze Neurologiche | Bologna | Bologna | 40139 | Italy |
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| Label | URL |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control Group | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | Score change | from baseline to the end of the light intervention period - 16 weeks |
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16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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The main limitation of our study was an unexpected, marked under-recruitment due to multiple factors, namely poorer motivation to participate by healthy people (instead of being affected by a condition as in usual intervention trials) and reduced trust in medical research by the general public. Despite our recrutiment efforts, we were forced to change the recruitment strategy by fractionating it in different stages and to shorten the observation time from 52 to 16 weeks.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Francesco Nonino, MD | Azienda USL di Bologna - IRCCS Istituto delle Scienze Neurologiche di Bologna | +390516225295 | f.nonino@ausl.bologna.it |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 24, 2023 | Feb 19, 2025 | Prot_SAP_000.pdf |
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| no indoor light | 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 |
|
| 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. | 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. | 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. | from baseline to the end of the light intervention period - 16 weeks |
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| BG001 | Control Group | 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 |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | 2 participants had missing data | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| Impact of electric light on sleep quality as measured with the Pittsburgh Sleep Quality Index (PSQI) | PSQI score 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. | Median | Inter-Quartile Range | Score on a scale |
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| EuroQol 5D | Perceived quality of life score, ranging from -0.57 (worst perceived quality of life) to 1 (best health state) | Median | Inter-Quartile Range | Score on a scale |
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| Dim Light Melatonin Onset (DLMO) | 7 sequential saliva samples will be collected at baseline in all recruited subjects. The saliva sampling will be performed hourly starting 5 hours prior to each individual's usual sleep onset until 1 hour after usual sleep onset. During sampling, the participant will remain in dim light conditions (< 10 lux) so that melatonin levels are not suppressed. The melatonin profile will allow calculation of the DLMO, a reliable proxy of circadian timing (phase). The reported values reflect clock time of melatonin onset in "hours". | Median | Inter-Quartile Range | Clock time (hours) |
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| Circadian rest-activity measures - Interdaily stability (IS) | Participants were given an actigraph (ActLumus, Condor Instruments) to be worn on their non-dominant wrist throughout day and night for 14 days during baseline and 14 days during follow-up to evaluate their rest-activity circadian rhythms. 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). | Median | Inter-Quartile Range | Normalized index |
|
| Circadian rest-activity measures - Relative amplitude (RA) | Participants wore an actigraph (ActLumus, Condor Instruments) on the non-dominant wrist for 14 days at baseline and 14 at follow-up to assess rest-activity circadian rhythms. 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. | Median | Inter-Quartile Range | Normalized index |
|
| Circadian rest-activity measures - Intradaily variability (IV) | Participants were given an actigraph (ActLumus, Condor Instruments) to be worn on their non-dominant wrist throughout day and night for 14 days during baseline and 14 days during follow-up to evaluate their rest-activity circadian rhythms. 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. | Median | Inter-Quartile Range | Normalized index |
|
| OG001 | Control Group | Persons allocated to the control group will receive no indoor light supplementation and will undergo assessment procedures only 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 |
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| Secondary | 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. | Posted | Median | Inter-Quartile Range | Score change | from baseline to the end of the light intervention period - 16 weeks |
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| Secondary | 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. | Posted | Median | Inter-Quartile Range | Normalized Index | from baseline to the end of the light intervention period - 16 weeks |
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| Secondary | 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. | Posted | Median | Inter-Quartile Range | Normalized Index | from baseline to the end of the light intervention period - 16 weeks |
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| Secondary | 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. | Posted | Median | Inter-Quartile Range | Normalized Index | from baseline to the end of the light intervention period - 16 weeks |
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| 0 |
| 98 |
| 0 |
| 98 |
| 0 |
| 98 |
| EG001 | Control Group | 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. | 0 | 93 | 0 | 93 | 0 | 93 |
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