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Color-dependent Melatonin Suppression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02936674
Recruitment Status : Completed
First Posted : October 18, 2016
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System

Brief Summary:
The purpose of this study is to examine the effects of complex, broad-band spectra light on the production of melatonin in humans.

Condition or disease Intervention/treatment Phase
Melatonin Device: Light - standard Device: Light - alternate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Study Start Date : October 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Arm Intervention/treatment
Experimental: Light 1
Light 1 will have an altered color composition as compared with a standard LED bulb.
Device: Light - alternate
Light will be given during the night to determine its effects on melatonin suppression. This light will be an LED with an altered spectral distribution (different color)

Active Comparator: Light 2
Light 2 will be a standard LED bulb.
Device: Light - standard
Light will be given during the night to determine its effects on melatonin suppression. This light will be an LED with standard spectral distribution




Primary Outcome Measures :
  1. Melatonin suppression [ Time Frame: 4 Hours ]
    The amount of declination of salivary melatonin concentrations between the start of the light and the end of the light (4 hours later) will be compared between the conditions.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Stable health
  • Normal color vision
  • Normal hearing
  • 18-35 years old

Exclusion Criteria:

  • Significant depressive symptoms
  • Pregnant or nursing
  • Ocular pathologies
  • Unstable or severe medical or psychiatric condition
  • Extreme morning/evening type
  • Regular smoker
  • Use of medications that impact ocular function
  • Alcohol use disorder
  • Use of illegal drugs
  • Irregular use of antihistamines, antidepressants, or sleeping medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02936674


Locations
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United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
Sponsors and Collaborators
VA Palo Alto Health Care System
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Responsible Party: Jamie M. Zeitzer, Ph.D., Assistant Professor, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier: NCT02936674    
Other Study ID Numbers: IRB-10165
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All relevant individual data will be published.