NCT05978934

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

May 15, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

August 7, 2023

Status Verified

July 1, 2023

Enrollment Period

7 months

First QC Date

April 27, 2023

Last Update Submit

July 28, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (10)

  • Sleep Quality

    Change in self-reported sleep quality over the course of each condition of the 16-week study.

  • Steps Taken

    Change in physical activity in steps per day over the course of each condition of the 16-week study.

  • Physical Activity

    Change in physical activity in minutes per day over the course of each condition of the 16-week study.

  • Working Memory

    Change in working memory performance over the course of each condition of the 16-week study.

  • Task Switching

    Change in task switching performance over the course of each condition of the 16-week study.

  • +5 more secondary outcomes

Study Arms (2)

L1 then L2 followed by L3 lighting condition

ACTIVE COMPARATOR

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)Behavioral: Dynamic Lighting Condition (L2)Behavioral: Dynamic Lighting Condition (L3)

L2 then L1 followed by L3 lighting condition

ACTIVE COMPARATOR

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)Behavioral: Dynamic Lighting Condition (L2)Behavioral: Dynamic Lighting Condition (L3)

Interventions

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

L1 then L2 followed by L3 lighting conditionL2 then L1 followed by L3 lighting condition

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.

L1 then L2 followed by L3 lighting conditionL2 then L1 followed by L3 lighting condition

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

L1 then L2 followed by L3 lighting conditionL2 then L1 followed by L3 lighting condition

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Is legally blind
  • Previously renovated their living units and no longer have the standard lighting installation offered by the Senior Living Facility;
  • 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);
  • Plan to travel to a different time zone during the study; or
  • Plan to be away from their residence for more than a week during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Waters on Mayowood

Rochester, Minnesota, 55901, United States

RECRUITING

Related Publications (1)

  • Mazurek KA, Li L, Klein RJ, Rong S, Mullan AF, Jones DT, St Louis EK, Worrell GA, Chen CY. Investigating the effects of indoor lighting on measures of brain health in older adults: protocol for a cross-over randomized controlled trial. BMC Geriatr. 2024 Oct 11;24(1):816. doi: 10.1186/s12877-023-04594-7.

MeSH Terms

Conditions

Motor ActivitySocial Isolation

Interventions

Long Interspersed Nucleotide Elementsinulin trinicotinate monomethochloride

Condition Hierarchy (Ancestors)

BehaviorSocial Behavior

Intervention Hierarchy (Ancestors)

RetroelementsInterspersed Repetitive SequencesRepetitive Sequences, Nucleic AcidBase SequenceMolecular StructureBiochemical PhenomenaChemical PhenomenaGenetic StructuresGenetic PhenomenaGenome ComponentsGenome

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2023

First Posted

August 7, 2023

Study Start

May 15, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

August 7, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations