Clinical trial NCT05978934: Determining How Indoor Lighting Affects the Brain Health of Older Adults
Official title: Determining How Indoor Lighting Affects the Brain Health of Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep
Physical Activity
Cognitive Function
Social Isolation
Lead sponsor: Well Living Lab, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Mayo Clinic
First posted: 2023-08-07
Enrollment: 70
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Total Sleep Time
timeFrame: Change in total sleep time per night over the course of each condition of the 16-week study.
measure: Wake After Sleep Onset
timeFrame: Change in wake after sleep onset per night over the course of each condition of the 16-week study.
measure: Sleep State Duration
timeFrame: Change in sleep state duration per night over the course of each condition of the 16-week study.
Secondary outcomes:
measure: Sleep Quality
timeFrame: Change in self-reported sleep quality over the course of each condition of the 16-week study.
measure: Steps Taken
timeFrame: Change in physical activity in steps per day over the course of each condition of the 16-week study.
measure: Physical Activity
timeFrame: Change in physical activity in minutes per day over the course of each condition of the 16-week study.
measure: Working Memory
timeFrame: Change in working memory performance over the course of each condition of the 16-week study.
measure: Task Switching
timeFrame: Change in task switching performance over the course of each condition of the 16-week study.
measure: Response Inhibition
timeFrame: Change in response inhibition performance over the course of each condition of the 16-week study.
measure: Sustained-Attention Reaction Time
timeFrame: Change in sustain-attention reaction time performance over the course of each condition of the 16-week study.
measure: Self-Reported Loneliness
timeFrame: Change in self-reported loneliness over the course of each condition of the 16-week study.
measure: Self-Reported Depression
timeFrame: Change in self-reported depression over the course of each condition of the 16-week study.
measure: Self-Reported Mood
timeFrame: Change in self-reported mood over the course of each condition of the 16-week study.
Other outcomes:
Locations:
city: Rochester
country: United States
facility: The Waters on Mayowood
state: Minnesota
Study officials:
References: