Bright Light as a Countermeasure for Circadian Desynchrony

This study is currently recruiting participants.

Verified June 2012 by VA Palo Alto Health Care System

Sponsor:

Collaborators:

Stanford University

Palo Alto Institute for Research and Education

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: June 19, 2012

Last verified: June 2012

History of Changes

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

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

Investigators

Principal Investigator:

Jamie M Zeitzer, PhD

Stanford University/VAPAHCS

More Information

Publications:

Zeitzer JM, Dijk DJ, Kronauer R, Brown E, Czeisler C. Sensitivity of the human circadian pacemaker to nocturnal light: melatonin phase resetting and suppression. J Physiol. 2000 Aug 1;526 Pt 3:695-702.

Cajochen C, Zeitzer JM, Czeisler CA, Dijk DJ. Dose-response relationship for light intensity and ocular and electroencephalographic correlates of human alertness. Behav Brain Res. 2000 Oct;115(1):75-83.

Zeitzer JM, Khalsa SB, Boivin DB, Duffy JF, Shanahan TL, Kronauer RE, Czeisler CA. Temporal dynamics of late-night photic stimulation of the human circadian timing system. Am J Physiol Regul Integr Comp Physiol. 2005 Sep;289(3):R839-44. Epub 2005 May 12.

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
Study First Received:	May 5, 2010
Last Updated:	June 19, 2012
Health Authority:	United States: Federal Government

Keywords provided by VA Palo Alto Health Care System:

Healthy controls

ClinicalTrials.gov processed this record on May 19, 2013

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