Recruiting

Observational Study

Sponsor:

Well Living Lab, Inc.

Code:

NCT05978934

Conditions

Sleep

Physical Activity

Cognitive Function

Social Isolation

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Interventions

Static Lighting Condition (L1)

Dynamic Lighting Condition (L2)

Dynamic Lighting Condition (L3)

Study Details

Brief summary:

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.

Conditions

Sleep

Physical Activity

Cognitive Function

Social Isolation

Study ID

NCT05978934

Start date

May 15, 2023

Status verified date

Jul, 2023

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

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 Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Static Lighting Condition (L1)

This indoor lighting condition keeps a constant brightness and correlated color temperature.

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.

Dynamic Lighting Condition (L3)

This exploratory indoor lighting condition matches the same pattern as L2 except the brightness in the morning hours is increased.

Primary outcome measure

  • Total Sleep Time [ Time Frame: Change in total sleep time per night over the course of each condition of the 16-week study. ]
  • Wake After Sleep Onset [ Time Frame: Change in wake after sleep onset per night over the course of each condition of the 16-week study. ]
  • Sleep State Duration [ Time Frame: Change in sleep state duration per night over the course of each condition of the 16-week study. ]

Central Contacts and Locations

Central contacts

Robert Klein, PhD

507-258-7592robert.klein@delos.com

Eric Heins

507-259-0611eric.heins@delos.com

Locations

The Waters on Mayowood

Recruiting

Rochester, Minnesota, United States, 55901

Contacts

Tianna Bagley

507-252-2910wonm@thewaters.com

Principal Investigator:

Christina Chen, MD

More Information

Sponsor

Well Living Lab, Inc.

Last update posted

Aug 7, 2023

Last verified

Jul, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Well Living Lab, Inc. on 2023-08-07.