Determining How Indoor Lighting Affects the Brain Health of Older Adults

The goal of this randomized, cross-over, single-site trial followed by an exploratory third intervention is to understand how indoor lighting affects different measures of brain health in older adults living in independent living residences. This is a community based study occurring in a local senior living facility. The main question this study aims to answer is:

- How does the quality of ambient indoor lighting an older adult is exposed to affect measures of brain health, such as sleep quality, physical activity, cognitive function, and social engagement?

Participants will be exposed to three different indoor lighting conditions for 4 weeks each while performing the following tasks:

• Wear a smartwatch throughout the study to measure sleep quality and physical activity
• Wear a small, wearable light sensor to measure light exposure during waking hours
• Perform cognitive assessments throughout the study to detect any changes between each of the lighting conditions
• Complete self-report of surveys to assess independence, social engagement, sleep quality, and mood

Results from these tasks will be compared within and between subjects to assess whether the different lighting conditions affect these different measures of brain health.

Study Overview

• Status: Recruiting
• Conditions: Physical Activity; Sleep; Cognitive Function; Social Isolation
• Intervention / Treatment: Behavioral: Static Lighting Condition (L1); Behavioral: Dynamic Lighting Condition (L2); Behavioral: Dynamic Lighting Condition (L3)

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric Heins; Phone Number: 507-259-0611; Email: eric.heins@delos.com
• Study Contact Backup: Name: Robert Klein, PhD; Phone Number: 507-258-7592; Email: robert.klein@delos.com

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55901
      • Recruiting
      • The Waters on Mayowood
      • Contact: Tianna Bagley; Phone Number: 507-252-2910; Email: wonm@thewaters.com
      • Principal Investigator: Christina Chen, MD
      • Principal Investigator: Kevin A Mazurek, PhD
      • Principal Investigator: Robert Klein, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. At least age 60;
2. Able to wear wearable devices throughout the study;
3. Willing to have their lighting in their kitchen and dining areas changed and controlled for the study;
4. Willing to have environmental sensors placed in their residence;
5. Willing to provide contact information about their primary care provider (PCP); and
6. Able and has capacity to provide informed consent (score > 14.5 based on UBACC consent capacity form).

Exclusion Criteria:

1. Is legally blind
2. Previously renovated their living units and no longer have the standard lighting installation offered by the Senior Living Facility;
3. Currently spend or plan to spend most of their day outside of their residence during the study (i.e., would not experience the indoor lighting intervention for the majority of the study);
4. Plan to travel to a different time zone during the study; or
5. Plan to be away from their residence for more than a week during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: L1 then L2 followed by L3 lighting condition; Participants will first experience a static lighting condition (L1) then a dynamic lighting condition (L2). After, participants will experience another dynamic lighting condition (L3) with increased morning brightness compared to L2.	Behavioral: Static Lighting Condition (L1); This indoor lighting condition keeps a constant brightness and correlated color temperature.; Behavioral: Dynamic Lighting Condition (L2); This indoor lighting condition has increased brightness and more blue correlated color temperature in the morning hours followed by decreased brightness and less blue correlated color temperature in the afternoon and evening hours.; Behavioral: Dynamic Lighting Condition (L3); This exploratory indoor lighting condition matches the same pattern as L2 except the brightness in the morning hours is increased.
Active Comparator: L2 then L1 followed by L3 lighting condition; Participants will first experience a dynamic lighting condition (L2) then a static lighting condition (L1). After, participants will experience another dynamic lighting condition (L3) with increased morning brightness compared to L2.	Behavioral: Static Lighting Condition (L1); This indoor lighting condition keeps a constant brightness and correlated color temperature.; Behavioral: Dynamic Lighting Condition (L2); This indoor lighting condition has increased brightness and more blue correlated color temperature in the morning hours followed by decreased brightness and less blue correlated color temperature in the afternoon and evening hours.; Behavioral: Dynamic Lighting Condition (L3); This exploratory indoor lighting condition matches the same pattern as L2 except the brightness in the morning hours is increased.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Sleep Time	Total sleep time per night in minutes as measured daily by a wearable device.	Change in total sleep time per night over the course of each condition of the 16-week study.
Wake After Sleep Onset	Wake after sleep onset per night in minutes as measured daily by a wearable device.	Change in wake after sleep onset per night over the course of each condition of the 16-week study.
Sleep State Duration	Sleep state duration per night in minutes as measured daily by a wearable device.	Change in sleep state duration per night over the course of each condition of the 16-week study.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Quality	Self-report measurement of perceived sleep quality made daily via the Groningen Sleep Quality Survey.	Change in self-reported sleep quality over the course of each condition of the 16-week study.
Steps Taken	Physical activity in steps per day as measured daily by a wearable device.	Change in physical activity in steps per day over the course of each condition of the 16-week study.
Physical Activity	Physical activity in minutes per day as measured daily by a wearable device.	Change in physical activity in minutes per day over the course of each condition of the 16-week study.
Working Memory	Task performance on a working memory assessment taken twice weekly.	Change in working memory performance over the course of each condition of the 16-week study.
Task Switching	Task performance on a task switching assessment taken twice weekly.	Change in task switching performance over the course of each condition of the 16-week study.
Response Inhibition	Task performance on a response inhibition assessment taken twice weekly.	Change in response inhibition performance over the course of each condition of the 16-week study.
Sustained-Attention Reaction Time	Task performance on a sustained-attention reaction time assessment taken twice weekly.	Change in sustain-attention reaction time performance over the course of each condition of the 16-week study.
Self-Reported Loneliness	Self-report measurement of loneliness assessed weekly via the UCLA Loneliness Scale.	Change in self-reported loneliness over the course of each condition of the 16-week study.
Self-Reported Depression	Self-report measurement of depression assessed weekly via the Positive and Negative Affect Scale.	Change in self-reported depression over the course of each condition of the 16-week study.
Self-Reported Mood	Self-report measurement of mood assessed weekly via the Depression, Anxiety, and Stress Scale.	Change in self-reported mood over the course of each condition of the 16-week study.

Collaborators and Investigators

• Sponsor: Well Living Lab, Inc.
• Collaborators: Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: April 27, 2023
• First Submitted That Met QC Criteria: July 28, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IRB 22-005400

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