Bright Light as a Countermeasure for Circadian Desynchrony

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by VA Palo Alto Health Care System
Sponsor:
Collaborators:
Stanford University
Palo Alto Institute for Research and Education, Inc
Information provided by (Responsible Party):
Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System
ClinicalTrials.gov Identifier:
NCT01119365
First received: May 5, 2010
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

Light is the primary means by which the internal circadian clock remains aligned ("entrained") with the external world. Misalignment of this internal clock can occur during situations such as shift work and jet travel across multiple time zones (jet lag). The purpose of this study is to examine the parameters of light and how they affect entrainment of the clock.


Condition Intervention
Healthy
Other: Bright light

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Bright Light as a Countermeasure for Circadian Desynchrony

Further study details as provided by VA Palo Alto Health Care System:

Primary Outcome Measures:
  • Circadian phase [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Circadian phase as ascertained through salivary melatonin concentrations


Secondary Outcome Measures:
  • Alertness [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Alertness as assessed through change in brain wave (electroencephalographic, EEG) activity, questionnaires, and objective testing


Estimated Enrollment: 80
Study Start Date: July 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Light
Bright light
Other: Bright light
Bright (1000 lux) light

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Good health
  • Normal hearing

Exclusion Criteria:

  • Sleep disorder
  • Extreme chronotype
  • Regular smoker
  • Depression
  • Alcohol abuse
  • Illegal drug use
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01119365

Contacts
Contact: Ban Ku 650-493-5000 ext 61971 banku@gmail.com

Locations
United States, California
VA Palo Alto Health Care System Recruiting
Palo Alto, California, United States, 94304
Principal Investigator: Jamie M Zeitzer, PhD         
Sponsors and Collaborators
VA Palo Alto Health Care System
Stanford University
Palo Alto Institute for Research and Education, Inc
Investigators
Principal Investigator: Jamie M Zeitzer, PhD Stanford University/VAPAHCS