- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03636360
The Impact of Artificial Sunlight on Human Sleep and Circadian Rhythms
March 29, 2021 updated by: Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Palo Alto, California, United States, 94304
- VA Palo Alto Health Care System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: LED - Sunlike
LED lighting with spectral pattern similar to that of sunlight
|
15 hours of light exposure
|
|
Active Comparator: Fluorescent
Fluorescent light at same illuminance (lux) as LED light
|
15 hours of light exposure
|
|
Placebo Comparator: Dim
Dim fluorescent light with same spectrum as "Fluorescent" condition
|
15 hours of light exposure
|
|
Active Comparator: LED
Standard LED lighting
|
15 hours of light exposure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alertness
Time Frame: 15 hours
|
Change in median reaction time score on the auditory psychomotor vigilance test
|
15 hours
|
|
Melatonin suppression
Time Frame: 3 hours
|
Amount of reduction in the concentration of salivary melatonin concentrations during an experimental light stimulus
|
3 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mood
Time Frame: 15 hours
|
Change in total positive and negative affect scores on the Positive and Negative Affect Schedule (PANAS)
|
15 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2019
Primary Completion (Actual)
March 1, 2021
Study Completion (Actual)
March 1, 2021
Study Registration Dates
First Submitted
August 2, 2018
First Submitted That Met QC Criteria
August 15, 2018
First Posted (Actual)
August 17, 2018
Study Record Updates
Last Update Posted (Actual)
March 30, 2021
Last Update Submitted That Met QC Criteria
March 29, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sunlike
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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