Back to resultsThe Impact of Artificial Sunlight on Human Sleep and Circadian Rhythms
Primary Purpose
Sleep, Circadian Dysregulation, Mood
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Light
Sponsored by
About this trial
This is an interventional basic science trial for Sleep
Eligibility Criteria
Inclusion Criteria:
- Good self-reported health
- Normal color vision
Exclusion Criteria:
- No sleep disorders
- No extreme chronotype
- Regular smoker
- Significant hearing loss
- Depression
- Alcohol use disorder
- Use of illegal drugs
- Pregnant
Sites / Locations
- VA Palo Alto Health Care System
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Placebo Comparator
Active Comparator
Arm Label
LED - Sunlike
Fluorescent
Dim
LED
Arm Description
LED lighting with spectral pattern similar to that of sunlight
Fluorescent light at same illuminance (lux) as LED light
Dim fluorescent light with same spectrum as "Fluorescent" condition
Standard LED lighting
Outcomes
Primary Outcome Measures
Alertness
Change in median reaction time score on the auditory psychomotor vigilance test
Melatonin suppression
Amount of reduction in the concentration of salivary melatonin concentrations during an experimental light stimulus
Secondary Outcome Measures
Mood
Change in total positive and negative affect scores on the Positive and Negative Affect Schedule (PANAS)
Full Information
NCT ID
NCT03636360
First Posted
August 2, 2018
Last Updated
March 29, 2021
Sponsor
VA Palo Alto Health Care System
Collaborators
Seoul Semiconductor
1. Study Identification
Unique Protocol Identification Number
NCT03636360
Brief Title
The Impact of Artificial Sunlight on Human Sleep and Circadian Rhythms
Official Title
The Impact of Artificial Sunlight on Human Sleep and Circadian Rhythms
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Palo Alto Health Care System
Collaborators
Seoul Semiconductor
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Circadian Dysregulation, Mood
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LED - Sunlike
Arm Type
Experimental
Arm Description
LED lighting with spectral pattern similar to that of sunlight
Arm Title
Fluorescent
Arm Type
Active Comparator
Arm Description
Fluorescent light at same illuminance (lux) as LED light
Arm Title
Dim
Arm Type
Placebo Comparator
Arm Description
Dim fluorescent light with same spectrum as "Fluorescent" condition
Arm Title
LED
Arm Type
Active Comparator
Arm Description
Standard LED lighting
Intervention Type
Device
Intervention Name(s)
Light
Intervention Description
15 hours of light exposure
Primary Outcome Measure Information:
Title
Alertness
Description
Change in median reaction time score on the auditory psychomotor vigilance test
Time Frame
15 hours
Title
Melatonin suppression
Description
Amount of reduction in the concentration of salivary melatonin concentrations during an experimental light stimulus
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
Mood
Description
Change in total positive and negative affect scores on the Positive and Negative Affect Schedule (PANAS)
Time Frame
15 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Good self-reported health
Normal color vision
Exclusion Criteria:
No sleep disorders
No extreme chronotype
Regular smoker
Significant hearing loss
Depression
Alcohol use disorder
Use of illegal drugs
Pregnant
Facility Information:
Facility Name
VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Impact of Artificial Sunlight on Human Sleep and Circadian Rhythms
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