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Completed

NCT Number: NCT05676086

Population Based Lighting Study on Older Adults

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).

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Irccs - Istituto Delle Scienze Neurologiche

Bologna, 40139, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Azienda Usl di Bologna

Other Gov

Registry information

Official study title

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

Acronym: ENLIGHTENme

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 9, 2023
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.