NCT05260801

Brief 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. 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.

Trial Health

45
At Risk

Trial Health Score

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

Timeline
7mo left

Started Dec 2024

Typical duration for not_applicable

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Dec 2024Nov 2026

First Submitted

Initial submission to the registry

February 18, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
2.8 years until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

2 years

First QC Date

February 18, 2022

Last Update Submit

July 19, 2023

Conditions

Keywords

Light intensityRemote workersSleepCognition

Outcome Measures

Primary Outcomes (9)

  • 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.

    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.

    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.

    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.

    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

    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.

    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.

    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.

    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)

    Once on the last day of week 1, 3, and 5

Secondary Outcomes (4)

  • Change in reaction time on Motor Praxis Task (MPT)

    Once on the last day of week 1, 3, and 5

  • Change in measure of abstraction: score on abstract matching test

    Once on the last day of week 1, 3, and 5

  • Change in the spatial orientation: score on line orientation test

    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)

    Once on the last day of week 1, 3, and 5

Study Arms (2)

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.

Other: Bright LightingOther: 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.

Other: Bright LightingOther: Placebo Lighting

Interventions

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.

Bright lighting followed by Placebo lightingPlacebo lighting followed by bright lighting

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.

Bright lighting followed by Placebo lightingPlacebo lighting followed by bright lighting

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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) \[reduced MEQ scores \>27 or \<11 are excluded; typical bedtime between 8 PM and 2 AM\]
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Nastaran Shishegar, PhD

    Arizona State University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 18, 2022

First Posted

March 2, 2022

Study Start

December 1, 2024

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

July 21, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share