SleepNCT05978934
Determining How Indoor Lighting Affects the Brain Health of Older Adults
A study testing Static Lighting Condition (L1), Dynamic Lighting Condition (L2) and Dynamic Lighting Condition (L3) in people with Sleep and Physical Activity, run by Well Living Lab, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep, Physical Activity, Cognitive Function
- What is being tested?
- Static Lighting Condition (L1), Dynamic Lighting Condition (L2) and Dynamic Lighting Condition (L3)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2023to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The Waters on Mayowood
Rochester, Minnesota, 55901
Tianna Bagley, 507-252-2910, wonm@thewaters.com
Christina Chen, MD
About this study
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?
Read more
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
- Being tested
- Static Lighting Condition (L1), Dynamic Lighting Condition (L2), Dynamic Lighting Condition (L3)
- Medical subject headings
- Motor Activity, Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static Lighting Condition (L1)Behavioural
This indoor lighting condition keeps a constant brightness and correlated color temperature.
Dynamic Lighting Condition (L2)Behavioural
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)Behavioural
This exploratory indoor lighting condition matches the same pattern as L2 except the brightness in the morning hours is increased.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Static Lighting Condition (L1); Behavioral: Dynamic Lighting Condition (L2); Behavioral: Dynamic Lighting Condition (L3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Sleep Time
Total sleep time per night in minutes as measured daily by a wearable device.
Measured: 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.
Measured: 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.
Measured: Change in sleep state duration per night over the course of each condition of the 16-week study.
Secondary outcomes (10)
Sleep Quality
Self-report measurement of perceived sleep quality made daily via the Groningen Sleep Quality Survey.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change in self-reported mood over the course of each condition of the 16-week study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start15 May 2023
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Well Living Lab, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978934
- Sponsor's protocol ID
- IRB 22-005400
- Status last verified
- Jul 2023
- First submitted
- 27 Apr 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39394603
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining How Indoor Lighting Affects the Brain Health of Older Adults
- ClinicalTrials.gov ID
- NCT05978934
- Acronym / sponsor ID
- IRB 22-005400
- Conditions
- Sleep, Physical Activity, Cognitive Function, Social Isolation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Well Living Lab, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Study start
- 15 May 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L1 then L2 followed by L3 lighting condition | Active comparator | Behavioral: Static Lighting Condition (L1), Behavioral: Dynamic Lighting Condition (L2), Behavioral: Dynamic Lighting Condition (L3)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. |
| L2 then L1 followed by L3 lighting condition | Active comparator | Behavioral: Static Lighting Condition (L1), Behavioral: Dynamic Lighting Condition (L2), Behavioral: Dynamic Lighting Condition (L3)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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Static Lighting Condition (L1)This indoor lighting condition keeps a constant brightness and correlated color temperature. | Behavioural | L1 then L2 followed by L3 lighting condition, L2 then L1 followed by L3 lighting condition |
| 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. | Behavioural | L1 then L2 followed by L3 lighting condition, L2 then L1 followed by L3 lighting condition |
| Dynamic Lighting Condition (L3)This exploratory indoor lighting condition matches the same pattern as L2 except the brightness in the morning hours is increased. | Behavioural | L1 then L2 followed by L3 lighting condition, L2 then L1 followed by L3 lighting condition |
Primary outcome
Total Sleep Time
Time frame: Change in total sleep time per night over the course of each condition of the 16-week study.
Total sleep time per night in minutes as measured daily by a wearable device.
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.
Wake after sleep onset per night in minutes as measured daily by a wearable device.
Sleep State Duration
Time frame: Change in sleep state duration per night over the course of each condition of the 16-week study.
Sleep state duration per night in minutes as measured daily by a wearable device.
10 secondary outcomes
Sleep Quality
Time frame: Change in self-reported sleep quality over the course of each condition of the 16-week study.
Steps Taken
Time frame: Change in physical activity in steps per day over the course of each condition of the 16-week study.
Physical Activity
Time frame: Change in physical activity in minutes per day over the course of each condition of the 16-week study.
Working Memory
Time frame: Change in working memory performance over the course of each condition of the 16-week study.
Task Switching
Time frame: Change in task switching performance over the course of each condition of the 16-week study.
Response Inhibition
Time frame: Change in response inhibition performance over the course of each condition of the 16-week study.
Sustained-Attention Reaction Time
Time frame: Change in sustain-attention reaction time performance over the course of each condition of the 16-week study.
Self-Reported Loneliness
Time frame: Change in self-reported loneliness over the course of each condition of the 16-week study.
Self-Reported Depression
Time frame: Change in self-reported depression over the course of each condition of the 16-week study.
Self-Reported Mood
Time frame: Change in self-reported mood over the course of each condition of the 16-week study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Derived from this study: PubMed 39394603Mazurek 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.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Static Lighting Condition (L1), Dynamic Lighting Condition (L2) and Dynamic Lighting Condition (L3) in people with Sleep and Physical Activity, run by Well Living Lab, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Klein, PhD (507-258-7592, robert.klein@delos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05978934, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.