The Impact of Artificial Sunlight on Human Sleep and Circadian Rhythms

• Sponsor: VA Palo Alto Health Care System (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT03636360
• Collaborator: Seoul Semiconductor (Other)
• Enrollment: 10
• Location: 1
• Arms: 4
• Actual Duration (Months): 20
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep; Circadian Dysregulation; Mood	Device: Light	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (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.
• Primary Purpose: Basic Science
• Official Title: The Impact of Artificial Sunlight on Human Sleep and Circadian Rhythms
• Actual Study Start Date: Jul 1, 2019
• Actual Primary Completion Date: Mar 1, 2021
• Actual Study Completion Date: Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LED - Sunlike LED lighting with spectral pattern similar to that of sunlight	Device: Light; 15 hours of light exposure
Active Comparator: Fluorescent Fluorescent light at same illuminance (lux) as LED light	Device: Light; 15 hours of light exposure
Placebo Comparator: Dim Dim fluorescent light with same spectrum as "Fluorescent" condition	Device: Light; 15 hours of light exposure
Active Comparator: LED Standard LED lighting	Device: Light; 15 hours of light exposure

Outcome Measures

Primary Outcome Measures

1. Alertness [15 hours]

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

2. Melatonin suppression [3 hours]

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

Secondary Outcome Measures

1. Mood [15 hours]

   Change in total positive and negative affect scores on the Positive and Negative Affect Schedule (PANAS)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Palo Alto Health Care System	Palo Alto	California	United States	94304

Sponsors and Collaborators

• VA Palo Alto Health Care System
• Seoul Semiconductor

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jamie M. Zeitzer, Ph.D., Associate Professor, VA Palo Alto Health Care System
• ClinicalTrials.gov Identifier: NCT03636360
• Other Study ID Numbers: Sunlike
• First Posted: Aug 17, 2018
• Last Update Posted: Mar 30, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Chronobiology Disorders

Study Results

No Results Posted as of Mar 30, 2021