Color-dependent Melatonin Suppression

January 3, 2018 updated by: Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System
The purpose of this study is to examine the effects of complex, broad-band spectra light on the production of melatonin in humans.

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

  • United States
    • 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:

  • 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

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 Hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Palo Alto Health Care System

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

October 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

October 7, 2016

First Submitted That Met QC Criteria

October 17, 2016

First Posted (Estimate)

October 18, 2016

Study Record Updates

Last Update Posted (Actual)

January 5, 2018

Last Update Submitted That Met QC Criteria

January 3, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • IRB-10165

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All relevant individual data will be published.

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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