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ENLIGHTENme: Population Based Lighting Study on Older Adults

Sponsor
Azienda Usl di Bologna (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05676086
Collaborator
(none)
600
Enrollment
1
Location
2
Arms
10.9
Anticipated Duration (Months)
54.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: indoor light intervention
  • Behavioral: no indoor light
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
INNOVATIVE POLICIES FOR IMPROVING CITIZENS' HEALTH AND WELLBEING ADDRESSING INDOOR AND OUTDOOR LIGHTING
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. impact of electric light on sleep quality [Basal+14 days]

    to evaluate the impact of electric light on sleep quality as measured with the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-reported questionnaire that measures sleep quality over the previous month. A higher 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.

Secondary Outcome Measures

  1. Change in photoentrainment [from baseline and the end of the light intervention period - 52 weeks]

    Change in photoentrainment as measured by the phase angle between DLMO and sleep onset between the baseline and the end of the light intervention period

  2. circadian rest-activity measures [from baseline and the end of the light intervention period - 52 weeks]

    Change in circadian rest-activity measures (IS, IV and RA) as well as sleep measures (SE and FI) as derived from actigraphic measurements between the baseline and the end of the light intervention period

  3. Change in mental and physical health [from baseline and the end of the light intervention period - 52 weeks]

    Change in mental and physical health as measured by validated and self-reported questionnaires between the baseline and the end of the light intervention period

  4. actigraphic and melatonin assays [- 52 weeks]

    Correlation between clinical parameters derived from actigraphic and melatonin assays and the polygenic risk score derived from publicly available summary statistics of Genome-Wide Association Studies (GWAS), as well as the mitochondrial DNA (mtDNA) haplotypes

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Irccs - Istituto Delle Scienze Neurologiche Bologna Italy 40139

Sponsors and Collaborators

  • Azienda Usl di Bologna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Azienda Usl di Bologna
ClinicalTrials.gov Identifier:
NCT05676086
Other Study ID Numbers:
  • 467-2022-SPER-AUSLBO
First Posted:
Jan 9, 2023
Last Update Posted:
Jan 9, 2023
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lightning Injuries

Study Results

No Results Posted as of Jan 9, 2023