Cognitive PerformanceNCT05481424
Evaluating the Potentials of Biodynamic Lighting for Home Office Workers
A study testing Biodynamic in people with Cognitive Performance and Sleep, run by Arizona State University at 1 site in United States.
Trial summary
This study examines the effectiveness of a biodynamic lighting intervention on the sleep, cognitive functions, and alertness of adults working from home. The biodynamic intervention is an innovative lighting solution that intends to harness both visual and non-visual effects of lighting through delivering varying… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Performance, Sleep, Alertness
- What is being tested?
- Biodynamic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 31 Mar 2024
- 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
- Good health [self-reported medical history]
- No evidence of sleep disorders [Pittsburgh Sleep Quality Index (PSQI) scores >5 are excluded]
- No extreme chronotypes (extreme owl or lark) [Morningness-Evningness Questionnaire (MEQ) scores >70 or <30 are excluded; typical bedtime between 8 PM and 2 AM]
- 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
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Light, Health, and Productivity: Evaluating the Potentials of Biodynamic Lighting for Home Office Workers
This study examines the effectiveness of a biodynamic lighting intervention on the sleep, cognitive functions, and alertness of adults working from home. The biodynamic intervention is an innovative lighting solution that intends to harness both visual and non-visual effects of lighting through delivering varying intensities and spectra during working hours according to a preset protocol.
Read the detailed description
The practice of working from home was widespread well before the 2020 Covid-19 pandemic; The Covid-19 pandemic pressed the fast-forward button on this trend. One of the biggest business concerns associated with working from home is how to maintain employees' productivity. Lighting has been proven as the main environmental element that significantly impacts office workers' health, sleep, mood, comfort, cognitive functions, and, consequently, productivity. One unintended aspect of working from home is the reduction in light exposure, especially in the contrast between the daytime and evening.
The effect of lighting on the office workers, including those working from home, could be roughly divided into two categories: visual route and non-visual route. Both visual and non-visual routes have received significant attention from researchers over the past decade. Yet, current literature lacks research involving a comprehensive approach that systematically evaluates the potential of biodynamic lighting interventions in home workplaces. None of the previous studies have evaluated lighting conditions in the home workplaces nor investigated the effects of lighting interventions on the health and productivity of adults working from home. With the rapid increase in the number of people moving to work from home, special attention should be paid to the lighting condition in home offices and its impacts on these workers.
This study examines the effectiveness of a biodynamic lighting intervention on the sleep, cognitive functions, and alertness of adults working from home. The biodynamic intervention is an innovative lighting solution that intends to harness both visual and non-visual effects of lighting through delivering varying intensities and spectra during working hours according to a preset protocol. Additionally, this study aims to compare the homeworkers' lighting conditions, impacts, and daily light exposure and how it is relevant to their sleep pattern and health. The specific aims of this study include:
- Aim 1: Examine the potential benefits of applying a biodynamic lighting condition in home offices for promoting sleep, cognitive functions, and alertness in remote workers.
- Aim 2: Objectively explore remote workers' daily light exposure pattern and model its relationship with their sleep quality.
Findings from this interdisciplinary study will provide insight into the potential benefits of applying biodynamic lighting in home workplaces for improving health and well-being in remote workers. Findings will also assist the lighting industry in providing necessary lighting technology and products aligned with the uprising trend of working from home.
- Conditions
- Cognitive Performance, Sleep, Alertness
- Being tested
- Biodynamic, Active Placebo
- Keywords
- Biodynamic Lighting, Sleep, Remote workers, Cognitive performance, light spectrum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiodynamicOther
This will be a nine-hour lighting scheme that includes three modes: morning, noon, and afternoon. It mimics natural lighting by providing blue-enriched bright lighting in the morning and yellowish dimmed lighting in the afternoon. The lighting scheme is designed to satisfy the visual lighting needs of office workers while maintaining a robust circadian clock.
Active PlaceboOther
We will include an active placebo condition that will be a whole-day lighting scheme with constant color and brightness during working hours. This condition is designed to serve to requirements: (1) to simulate a conventional, well-lit office lighting in compliance with the WELL standard V1 recommendations for circadian lighting design, and (2) to provide an Equivalent Melanopic Lux (EML) equal to the geometric average of EML delivered by the Biodynamic condition. Participants will receive a similar dose of lighting under both the Placebo and Biodynamic conditions; however, the "time" factor is ignored in the Placebo, and hence the method of delivery is different (constant versus dynamic).
| Study group | Role | What they receive |
|---|---|---|
| Biodynamic Condition followed by an Active Placebo Condition. | 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: Biodynamic; Other: Active Placebo |
| Active Placebo Condition followed by Biodynamic Condition | 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: Biodynamic; Other: Active Placebo |
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 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 per day, Monday to Friday, during 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 per day, Monday to Friday, during 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. A shorter median reaction time corresponds to more attentive state.
Measured: Once per day, Monday to Friday, during 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 per day, Monday to Friday, during 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 per day, Monday to Friday, during week 1, 3, and 5
Secondary outcomes (4)
Change in motor speed as assessed by Motor Praxis Task
Participants are to quickly touch ever-shrinking boxes. Each time a new box appears in a different location on the screen. A shorter reaction time corresponds to higher sensory motor speed.
Measured: Once per day, Monday to Friday, during 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 per day, Monday to Friday, during 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 per day, Monday to Friday, during 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 per day, Monday to Friday, during 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 posted1 Aug 2022
- Study start1 Oct 2022
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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=25), 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Korrus Inc.
- Responsible party
- Principal investigator, Nina Sharp, Arizona State University
- Investigators
- nina Sharp, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481424
- Sponsor's protocol ID
- STUDY00015724
- Status last verified
- Jul 2024
- First submitted
- 28 Jul 2022
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: No individual participant data will be shared. Results will be published by the investigators in academic journals and conference proceedings. However, neither the name nor identity of the participants will be used in any publications. Sharing of generated study data will be carried out in several different ways. We plan to make our results available to researchers and potential collaborators interested in human-light interactions.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Light, Health, and Productivity: Evaluating the Potentials of Biodynamic Lighting for Home Office Workers
- ClinicalTrials.gov ID
- NCT05481424
- Acronym / sponsor ID
- STUDY00015724
- Conditions
- Cognitive Performance, Sleep, Alertness
- Keywords
- Biodynamic Lighting, Sleep, Remote workers, Cognitive performance, light spectrum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Korrus Inc.
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 1 Aug 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.
This study examines the effectiveness of a biodynamic lighting intervention on the sleep, cognitive functions, and alertness of adults working from home. The biodynamic intervention is an innovative lighting solution that intends to harness both visual and non-visual effects of lighting through delivering varying intensities and spectra during working hours according to a preset protocol.
Detailed description
The practice of working from home was widespread well before the 2020 Covid-19 pandemic; The Covid-19 pandemic pressed the fast-forward button on this trend. One of the biggest business concerns associated with working from home is how to maintain employees' productivity. Lighting has been proven as the main environmental element that significantly impacts office workers' health, sleep, mood, comfort, cognitive functions, and, consequently, productivity. One unintended aspect of working from home is the reduction in light exposure, especially in the contrast between the daytime and evening.
The effect of lighting on the office workers, including those working from home, could be roughly divided into two categories: visual route and non-visual route. Both visual and non-visual routes have received significant attention from researchers over the past decade. Yet, current literature lacks research involving a comprehensive approach that systematically evaluates the potential of biodynamic lighting interventions in home workplaces. None of the previous studies have evaluated lighting conditions in the home workplaces nor investigated the effects of lighting interventions on the health and productivity of adults working from home. With the rapid increase in the number of people moving to work from home, special attention should be paid to the lighting condition in home offices and its impacts on these workers.
This study examines the effectiveness of a biodynamic lighting intervention on the sleep, cognitive functions, and alertness of adults working from home. The biodynamic intervention is an innovative lighting solution that intends to harness both visual and non-visual effects of lighting through delivering varying intensities and spectra during working hours according to a preset protocol. Additionally, this study aims to compare the homeworkers' lighting conditions, impacts, and daily light exposure and how it is relevant to their sleep pattern and health. The specific aims of this study include:
- Aim 1: Examine the potential benefits of applying a biodynamic lighting condition in home offices for promoting sleep, cognitive functions, and alertness in remote workers.
- Aim 2: Objectively explore remote workers' daily light exposure pattern and model its relationship with their sleep quality.
Findings from this interdisciplinary study will provide insight into the potential benefits of applying biodynamic lighting in home workplaces for improving health and well-being in remote workers. Findings will also assist the lighting industry in providing necessary lighting technology and products aligned with the uprising trend of working from home.
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=25), 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 |
|---|---|---|
| Biodynamic Condition followed by an Active Placebo Condition. | Experimental | Other: Biodynamic, Other: Active PlaceboEach 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. |
| Active Placebo Condition followed by Biodynamic Condition | Experimental | Other: Biodynamic, Other: Active PlaceboEach 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 (8 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
- Good health [self-reported medical history]
- No evidence of sleep disorders [Pittsburgh Sleep Quality Index (PSQI) scores >5 are excluded]
- No extreme chronotypes (extreme owl or lark) [Morningness-Evningness Questionnaire (MEQ) scores >70 or <30 are excluded; typical bedtime between 8 PM and 2 AM]
- Normal color vision [as per Ishihara's Tests for Colour Deficiency]
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 |
|---|---|---|
| BiodynamicThis will be a nine-hour lighting scheme that includes three modes: morning, noon, and afternoon. It mimics natural lighting by providing blue-enriched bright lighting in the morning and yellowish dimmed lighting in the afternoon. The lighting scheme is designed to satisfy the visual lighting needs of office workers while maintaining a robust circadian clock. | Other | Active Placebo Condition followed by Biodynamic Condition, Biodynamic Condition followed by an Active Placebo Condition. |
| Active PlaceboWe will include an active placebo condition that will be a whole-day lighting scheme with constant color and brightness during working hours. This condition is designed to serve to requirements: (1) to simulate a conventional, well-lit office lighting in compliance with the WELL standard V1 recommendations for circadian lighting design, and (2) to provide an Equivalent Melanopic Lux (EML) equal to the geometric average of EML delivered by the Biodynamic condition. Participants will receive a similar dose of lighting under both the Placebo and Biodynamic conditions; however, the "time" factor is ignored in the Placebo, and hence the method of delivery is different (constant versus dynamic). | Other | Active Placebo Condition followed by Biodynamic Condition, Biodynamic Condition followed by an Active Placebo Condition. |
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 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 per day, Monday to Friday, during 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 per day, Monday to Friday, during 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 per day, Monday to Friday, during 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. A shorter median reaction time corresponds to more attentive state.
Change in Balloon Analogue Risk Task (BART) score
Time frame: Once per day, Monday to Friday, during 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 per day, Monday to Friday, during 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 motor speed as assessed by Motor Praxis Task
Time frame: Once per day, Monday to Friday, during week 1, 3, and 5
Change in measure of abstraction: score on abstract matching test
Time frame: Once per day, Monday to Friday, during week 1, 3, and 5
Change in the spatial orientation: score on line orientation test
Time frame: Once per day, Monday to Friday, during week 1, 3, and 5
Change in complex scanning and visual tracking: score on Digit Symbol Substitution Task (DSST)
Time frame: Once per day, Monday to Friday, during week 1, 3, and 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: Yes. No individual participant data will be shared. Results will be published by the investigators in academic journals and conference proceedings. However, neither the name nor identity of the participants will be used in any publications. Sharing of generated study data will be carried out in several different ways. We plan to make our results available to researchers and potential collaborators interested in human-light interactions.
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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.
nina Sharp, PhD principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biodynamic in people with Cognitive Performance and Sleep, run by Arizona State University 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 8 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: finished, as of the sponsor's last update on 30 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 8 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 30 Jul 2024.