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Bright Light as a Countermeasure for Circadian Desynchrony

This study is currently recruiting participants.
Verified November 2016 by Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System
Sponsor:
ClinicalTrials.gov Identifier:
NCT01119365
First Posted: May 7, 2010
Last Update Posted: November 2, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Stanford University
Palo Alto Veterans Institute for Research
Information provided by (Responsible Party):
Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System
  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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Bright Light as a Countermeasure for Circadian Desynchrony

Further study details as provided by Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System:

Primary Outcome Measures:
  • Circadian phase [ Time Frame: 1 week ]
    Circadian phase as ascertained through salivary melatonin concentrations


Secondary Outcome Measures:
  • Alertness [ Time Frame: 1 hour ]
    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 2021
Estimated Primary Completion Date: June 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Light
Bright light
Other: Bright light
Bright (1000 lux) light

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
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
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): NCT01119365


Contacts
Contact: Yvonne Quevedo 650-493-5000 ext 61971 pavasleepstudy@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 Veterans Institute for Research
Investigators
Principal Investigator: Jamie M Zeitzer, PhD Stanford University/VAPAHCS
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jamie M. Zeitzer, Ph.D., Assistant Professor, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier: NCT01119365     History of Changes
Other Study ID Numbers: 10165
First Submitted: May 5, 2010
First Posted: May 7, 2010
Last Update Posted: November 2, 2016
Last Verified: November 2016

Keywords provided by Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System:
Healthy controls