NCT03636360

Brief Summary

The purpose of this study is to examine, in healthy controls, whether LED lighting that has a color spectrum similar to that of sunlight is able to differentially impact mood, circadian rhythms, sleep, and behavior, as compared to standard fluorescent lighting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

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

August 2, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

1.7 years

First QC Date

August 2, 2018

Last Update Submit

March 29, 2021

Conditions

SleepCircadian DysregulationMood

Outcome Measures

Primary Outcomes (2)

  • Alertness

    Change in median reaction time score on the auditory psychomotor vigilance test

    15 hours

  • Melatonin suppression

    Amount of reduction in the concentration of salivary melatonin concentrations during an experimental light stimulus

    3 hours

Secondary Outcomes (1)

  • Mood

    15 hours

Study Arms (4)

LED - Sunlike

EXPERIMENTAL

LED lighting with spectral pattern similar to that of sunlight

Device: Light

Fluorescent

ACTIVE COMPARATOR

Fluorescent light at same illuminance (lux) as LED light

Device: Light

Dim

PLACEBO COMPARATOR

Dim fluorescent light with same spectrum as "Fluorescent" condition

Device: Light

LED

ACTIVE COMPARATOR

Standard LED lighting

Device: Light

Interventions

LightDEVICE

15 hours of light exposure

DimFluorescentLEDLED - Sunlike

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Good self-reported health
  • Normal color vision

You may not qualify if:

  • No sleep disorders
  • No extreme chronotype
  • Regular smoker
  • Significant hearing loss
  • Depression
  • Alcohol use disorder
  • Use of illegal drugs
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Chronobiology Disorders

Interventions

Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Nervous System Diseases

Intervention Hierarchy (Ancestors)

PhototherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be aware that the lighting conditions will vary during their visits, but will not be aware of the nature of the difference in the lights.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 2, 2018

First Posted

August 17, 2018

Study Start

July 1, 2019

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

March 30, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)