Daytime Cognitive PerformanceNCT05260801
The Impact of Light Intensity in Home Workplaces on Remote Workers' Health
A study testing Bright Lighting in people with Daytime Cognitive Performance and Sleep, run by Arizona State University.
Trial summary
The lockdowns and restrictions associated with the COVID-19 have created a seismic shift in where work is done. Prior to the pandemic, approximately 20% of individuals were working from home while during the pandemic, more than 70% of individuals worked from home. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Daytime Cognitive Performance, Sleep, Alertness
- What is being tested?
- Bright Lighting
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 30 Nov 2026
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have an occupation of a dayshift (i.e., occurring between 6 AM and 8 PM) remote office worker, working from home for five days (Monday→Friday) a week with a maximum of 12 hours per day.
- Aged 18-65
- Good health [self-reported medical history]
- Female or male
- No evidence of sleep disorders [PSQI scores >5 are excluded]
- No extreme chronotypes (extreme owl or lark) [reduced MEQ scores >27 or <11 are excluded; typical bedtime between 8 PM and 2 AM]
Show all 14Show fewer
- Non-smoker
- Not abusing alcohol [AUDIT scores >19 are excluded]
- Not experiencing depression [CES-D scores >27 are excluded]
- Best-corrected visual acuity of 20/200 or higher
- Normal color vision [as per Ishihara's Tests for Colour Deficiency]
- No current or planned use of light therapy or light-altering devices (e.g., blue-blocking and/or tinted glasses and contact lenses)
- No planned upcoming travel during the study participation period
- Not pregnant
Who cannot join
- -
About this study
Official title: The Impact of Daytime Light Intensity in Home Workplaces on Health and Well-being of Remote Workers.
The lockdowns and restrictions associated with the COVID-19 have created a seismic shift in where work is done. Prior to the pandemic, approximately 20% of individuals were working from home while during the pandemic, more than 70% of individuals worked from home. While it is unlikely that such a large percent of the population will remain working from home, the vast support from workers for such work arrangements and the potential increase in productivity means that there will likely be a revision of the work place with more individuals working from a home office environment than have done so in the past. One unintended aspect of working from home is a reduction in light exposure, especially in the contrast between the daytime and evening. Offices converted from bedrooms, basements, and kitchens are often illuminated in the recommended 50-100 lux range, as opposed to the approximately 500 lux of most offices. While this light intensity is sufficient to work or read by, it may be insufficient to maintain adequate mental and physical health. In addition to light allowing us to consciously perceive the world around us, light can also induce a variety of changes in physiology that can impact our health, notably inducing shifts in the timing of circadian rhythms, suppressing the onset of melatonin production, and increasing alertness with subsequent changes to sleep latency and architecture. These changes in sleep and circadian rhythms have been associated with a variety of pathologies including increased risk of metabolic, psychiatric, cognitive, and cardiovascular disorders, in addition to overall longevity. Development of an adequate prophylactic countermeasure for the circadian desynchrony to which home office workers are exposed is a critical step in maintaining the health of these individuals. There are two main studies. The first study (Years 1-2) will be an in-laboratory determination of the threshold of light needed to minimize the negative impact of nocturnal light exposure. The second study (Years 3-4) will be a field study applying this threshold to determine if whether in situ use of this light intensity during the day improves health and safety among home office workers.
Current CT.gov represents the second part of this study i.e. "Study 2: The impact of daytime light intensity in home workplaces on health and well-being of remote workers. In study 2, investigators will examine a series of participants (N=36), each of whom will participate in a five-week experiment. Each participant will have a screening visit at their home. The study will be conducted over five successive one-week periods with two cohorts of participants experiencing the same series of lighting interventions. All data collection will be performed during the working days (Monday - Friday) when participants are exposed to the lighting in their home offices.
- Conditions
- Daytime Cognitive Performance, Sleep, Alertness
- Being tested
- Bright Lighting, Placebo Lighting
- Keywords
- Light intensity, Remote workers, Sleep, Cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright LightingOther
The bright lighting condition will administer the light intensity as determined from the finding of Study 1. Bright lighting condition will last for two weeks (Weeks 2-3 or 4-5), be limited to the 10 workdays, and be active for 8 hours per day.
Placebo LightingOther
The placebo condition will expose participants to 150 lux, a light level that is equivalent to average room lighting. Placebo lighting condition will last for two weeks (Weeks 2-3 or 4-5), be limited to the 10 workdays, and be active for 8 hours per day. The placebo lighting condition will be applied to minimize the bias and false improvements that might occur due to experiencing new lighting conditions and devices.
| Study group | Role | What they receive |
|---|---|---|
| Bright lighting followed by Placebo lighting | Experimental | Each lighting condition will last for two weeks (Weeks 2-3 or 4-5), be limited to the 10 workdays, and be active for 8 hours per day. The order of conditions will be randomized. Receives: Other: Bright Lighting; Other: Placebo Lighting |
| Placebo lighting followed by bright lighting | Experimental | Each lighting condition will last for two weeks (Weeks 2-3 or 4-5), be limited to the 10 workdays, and be active for 8 hours per day. The order of conditions will be randomized. Receives: Other: Bright Lighting; Other: Placebo Lighting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Nocturnal Sleep Duration (in minutes) as measured by actigraphy
Nocturnal Sleep Duration (in minutes) will be measured by Actigraphy. Longer sleep duration corresponds to improved sleep outcomes.
Measured: 24 hours everyday up to week 5
Change in Percent Sleep Efficiency (total sleep time divided by time in bed) measured by actigraphy
Percent Sleep Efficiency measured by actigraphy. Higher percentage corresponds to higher sleep quality.
Measured: 24 hours everyday up to week 5
Change in the minutes of wake after sleep onset measured by actigraphy
The investigators will measure patients total time awake between initial sleep onset and the final morning awakening in minutes.
Measured: Everyday up to week 5]
Change in the Subjective Sleep quality as measured by a single Likert-like question qualitatively
This is included in the consensus sleep diary and consists of 1 question that is scaled from 1 to 7, with higher score corresponds to poor quality sleep.
Measured: everyday up to 5 weeks
Change in working memory as assessed by fractal 2-back score
Fractal 2-back score is based on number of correct responses. Higher test scores indicates better performance of working memory
Measured: Once on the last day of week 1, 3, and 5
Change in working Memory as assessed by Visual Object Learning Task (VOLT) score
Participants first memorize a set of 3-dimensional Euclidean shapes. During recall, participants are to distinguish between the initial shapes mixed with ten distractor shapes. Score is based on number of correct responses.
Measured: Once on the last day of week 1, 3, and 5
Change in median reaction time on Psychomotor Vigilance test
Psychomotor vigilance test(PVT) measures alertness and vigilant attention and is considered to be the gold standard measure of neurobehavioral effects of circadian misalignment and sleep loss. Shorter median reaction times corresponds to more attentive state.
Measured: Once on the last day of week 1, 3, and 5
Change in Balloon Analogue Risk Task (BART) score
Participants inflate balloons of unknown popping probability to obtain the highest reward. Each pump increases the potential reward. The potential reward is lost if the balloon pops.
Scores are calculated by adding the number of pumps for unexploded balloons, with higher scores reflecting greater risk-taking. Range varies - explosions are at a random point between 1 and 128 pumps.
Measured: Once on the last day of week 1, 3, and 5
Change in subjective alertness as assessed by Stanford Sleepiness Scale (SSS)
SSS is a s self-reported Likert-type sleepiness scale which assess mental and physical sedation and sleepiness, respectively, at that moment and time. SSS only consists of 1 question that is scaled from 1 to 7, with 7 being a higher or worse score (i.e. more sleepy and sedated)
Measured: Once on the last day of week 1, 3, and 5
Secondary outcomes (4)
Change in reaction time on Motor Praxis Task (MPT)
Participants are to quickly touch ever-shrinking boxes. Each time a new box appears in a different location on the screen. Shorter reaction time corresponds to higher sensory motor speed.
Measured: Once on the last day of week 1, 3, and 5
Change in measure of abstraction: score on abstract matching test
Participants select pairs of shapes that fit with another shape. Higher number of correct responses corresponds to higher measure of abstraction.
Measured: Once on the last day of week 1, 3, and 5
Change in the spatial orientation: score on line orientation test
Participants are shown two lines at different angles, and are to rotate one line incrementally until it is parallel to the other. Higher scores corresponds to better spatial orientation.
Measured: Once on the last day of week 1, 3, and 5
Change in complex scanning and visual tracking: score on Digit Symbol Substitution Task (DSST)
Participants touch the number paired to the symbol that matches the current target symbol. Higher score corresponds to better complex scanning and visual tracking capability.
Measured: Once on the last day of week 1, 3, and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Dec 2024 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Why it stopped: We did not receive funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Daytime Cognitive PerformanceStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Investigators will examine a series of participants (N=36), each of whom will participate in a five-week experiment. Each participant will have a screening visit at their home. The study will be conducted over five successive one-week periods with two cohorts of participants experiencing the same series of lighting interventions. All data collection will be performed during the working days (Monday - Friday) when participants are exposed to the lighting in their home offices.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nina Sharp, Arizona State University
- Investigators
- Nastaran Shishegar, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260801
- Sponsor's protocol ID
- Study 2
- Status last verified
- Jul 2023
- First submitted
- 18 Feb 2022
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Daytime Light Intensity in Home Workplaces on Health and Well-being of Remote Workers.
- ClinicalTrials.gov ID
- NCT05260801
- Acronym / sponsor ID
- Study 2
- Conditions
- Daytime Cognitive Performance, Sleep, Alertness
- Keywords
- Light intensity, Remote workers, Sleep, Cognition
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We did not receive funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 2 Mar 2022 (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 lockdowns and restrictions associated with the COVID-19 have created a seismic shift in where work is done. Prior to the pandemic, approximately 20% of individuals were working from home while during the pandemic, more than 70% of individuals worked from home. While it is unlikely that such a large percent of the population will remain working from home, the vast support from workers for such work arrangements and the potential increase in productivity means that there will likely be a revision of the work place with more individuals working from a home office environment than have done so in the past. One unintended aspect of working from home is a reduction in light exposure, especially in the contrast between the daytime and evening. Offices converted from bedrooms, basements, and kitchens are often illuminated in the recommended 50-100 lux range, as opposed to the approximately 500 lux of most offices. While this light intensity is sufficient to work or read by, it may be insufficient to maintain adequate mental and physical health. In addition to light allowing us to consciously perceive the world around us, light can also induce a variety of changes in physiology that can impact our health, notably inducing shifts in the timing of circadian rhythms, suppressing the onset of melatonin production, and increasing alertness with subsequent changes to sleep latency and architecture. These changes in sleep and circadian rhythms have been associated with a variety of pathologies including increased risk of metabolic, psychiatric, cognitive, and cardiovascular disorders, in addition to overall longevity. Development of an adequate prophylactic countermeasure for the circadian desynchrony to which home office workers are exposed is a critical step in maintaining the health of these individuals. There are two main studies. The first study (Years 1-2) will be an in-laboratory determination of the threshold of light needed to minimize the negative impact of nocturnal light exposure. The second study (Years 3-4) will be a field study applying this threshold to determine if whether in situ use of this light intensity during the day improves health and safety among home office workers.
Current CT.gov represents the second part of this study i.e. "Study 2: The impact of daytime light intensity in home workplaces on health and well-being of remote workers. In study 2, investigators will examine a series of participants (N=36), each of whom will participate in a five-week experiment. Each participant will have a screening visit at their home. The study will be conducted over five successive one-week periods with two cohorts of participants experiencing the same series of lighting interventions. All data collection will be performed during the working days (Monday - Friday) when participants are exposed to the lighting in their home offices.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Investigators will examine a series of participants (N=36), each of whom will participate in a five-week experiment. Each participant will have a screening visit at their home. The study will be conducted over five successive one-week periods with two cohorts of participants experiencing the same series of lighting interventions. All data collection will be performed during the working days (Monday - Friday) when participants are exposed to the lighting in their home offices.
| Arm | Type | Receives |
|---|---|---|
| Bright lighting followed by Placebo lighting | Experimental | Other: Bright Lighting, Other: Placebo LightingEach lighting condition will last for two weeks (Weeks 2-3 or 4-5), be limited to the 10 workdays, and be active for 8 hours per day. The order of conditions will be randomized. |
| Placebo lighting followed by bright lighting | Experimental | Other: Bright Lighting, Other: Placebo LightingEach lighting condition will last for two weeks (Weeks 2-3 or 4-5), be limited to the 10 workdays, and be active for 8 hours per day. The order of conditions will be randomized. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Have an occupation of a dayshift (i.e., occurring between 6 AM and 8 PM) remote office worker, working from home for five days (Monday→Friday) a week with a maximum of 12 hours per day.
- Aged 18-65
- Good health [self-reported medical history]
- Female or male
- No evidence of sleep disorders [PSQI scores >5 are excluded]
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Bright LightingThe bright lighting condition will administer the light intensity as determined from the finding of Study 1. Bright lighting condition will last for two weeks (Weeks 2-3 or 4-5), be limited to the 10 workdays, and be active for 8 hours per day. | Other | Bright lighting followed by Placebo lighting, Placebo lighting followed by bright lighting |
| Placebo LightingThe placebo condition will expose participants to 150 lux, a light level that is equivalent to average room lighting. Placebo lighting condition will last for two weeks (Weeks 2-3 or 4-5), be limited to the 10 workdays, and be active for 8 hours per day. The placebo lighting condition will be applied to minimize the bias and false improvements that might occur due to experiencing new lighting conditions and devices. | Other | Bright lighting followed by Placebo lighting, Placebo lighting followed by bright lighting |
Primary outcome
Change in Nocturnal Sleep Duration (in minutes) as measured by actigraphy
Time frame: 24 hours everyday up to week 5
Nocturnal Sleep Duration (in minutes) will be measured by Actigraphy. Longer sleep duration corresponds to improved sleep outcomes.
Change in Percent Sleep Efficiency (total sleep time divided by time in bed) measured by actigraphy
Time frame: 24 hours everyday up to week 5
Percent Sleep Efficiency measured by actigraphy. Higher percentage corresponds to higher sleep quality.
Change in the minutes of wake after sleep onset measured by actigraphy
Time frame: Everyday up to week 5]
The investigators will measure patients total time awake between initial sleep onset and the final morning awakening in minutes.
Change in the Subjective Sleep quality as measured by a single Likert-like question qualitatively
Time frame: everyday up to 5 weeks
This is included in the consensus sleep diary and consists of 1 question that is scaled from 1 to 7, with higher score corresponds to poor quality sleep.
Change in working memory as assessed by fractal 2-back score
Time frame: Once on the last day of week 1, 3, and 5
Fractal 2-back score is based on number of correct responses. Higher test scores indicates better performance of working memory
Change in working Memory as assessed by Visual Object Learning Task (VOLT) score
Time frame: Once on the last day of week 1, 3, and 5
Participants first memorize a set of 3-dimensional Euclidean shapes. During recall, participants are to distinguish between the initial shapes mixed with ten distractor shapes. Score is based on number of correct responses.
Change in median reaction time on Psychomotor Vigilance test
Time frame: Once on the last day of week 1, 3, and 5
Psychomotor vigilance test(PVT) measures alertness and vigilant attention and is considered to be the gold standard measure of neurobehavioral effects of circadian misalignment and sleep loss. Shorter median reaction times corresponds to more attentive state.
Change in Balloon Analogue Risk Task (BART) score
Time frame: Once on the last day of week 1, 3, and 5
Participants inflate balloons of unknown popping probability to obtain the highest reward. Each pump increases the potential reward. The potential reward is lost if the balloon pops. Scores are calculated by adding the number of pumps for unexploded balloons, with higher scores reflecting greater risk-taking. Range varies - explosions are at a random point between 1 and 128 pumps.
Change in subjective alertness as assessed by Stanford Sleepiness Scale (SSS)
Time frame: Once on the last day of week 1, 3, and 5
SSS is a s self-reported Likert-type sleepiness scale which assess mental and physical sedation and sleepiness, respectively, at that moment and time. SSS only consists of 1 question that is scaled from 1 to 7, with 7 being a higher or worse score (i.e. more sleepy and sedated)
4 secondary outcomes
Change in reaction time on Motor Praxis Task (MPT)
Time frame: Once on the last day of week 1, 3, and 5
Change in measure of abstraction: score on abstract matching test
Time frame: Once on the last day of week 1, 3, and 5
Change in the spatial orientation: score on line orientation test
Time frame: Once on the last day of week 1, 3, and 5
Change in complex scanning and visual tracking: score on Digit Symbol Substitution Task (DSST)
Time frame: Once on the last day of week 1, 3, and 5
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Nastaran Shishegar, PhD principal investigator
Arizona State University
Questions about this trial
What is this clinical trial studying?
A study testing Bright Lighting in people with Daytime Cognitive Performance and Sleep, run by Arizona State University.
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 14 inclusion and 1 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: withdrawn, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Nocturnal Sleep Duration (in minutes) as measured by actigraphy (time frame: 24 hours everyday up to week 5). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2023.