NCT05481424

Brief 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 intensities and spectra during working hours according to a preset protocol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

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

July 28, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

1.5 years

First QC Date

July 28, 2022

Last Update Submit

July 29, 2024

Conditions

Keywords

Biodynamic LightingSleepRemote workersCognitive performancelight spectrum

Outcome Measures

Primary Outcomes (8)

  • 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 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 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.

    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.

    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.

    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)

    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

    Once per day, Monday to Friday, during week 1, 3, and 5

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

    Once per day, Monday to Friday, during week 1, 3, and 5

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

    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)

    Once per day, Monday to Friday, during week 1, 3, and 5

Study Arms (2)

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.

Other: BiodynamicOther: 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.

Other: BiodynamicOther: Active Placebo

Interventions

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 Placebo Condition followed by Biodynamic ConditionBiodynamic Condition followed by an Active Placebo Condition.

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).

Active Placebo Condition followed by Biodynamic ConditionBiodynamic Condition followed by an Active Placebo Condition.

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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASU DeSmart Lab

Tempe, Arizona, 85281, United States

Location

Study Officials

  • nina Sharp, PhD

    Arizona State University

    PRINCIPAL INVESTIGATOR

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=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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 28, 2022

First Posted

August 1, 2022

Study Start

October 1, 2022

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

July 30, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

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.

Time Frame
The data will be available after the data collection and analysis is complete which is anticipated to be in January 2024. The findings will be published in academic journals.

Locations