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:
VA Palo Alto Health Care System
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
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | May 5, 2010 | ||||
| Last Updated Date | June 19, 2012 | ||||
| Start Date ICMJE | July 2011 | ||||
| Estimated Primary Completion Date | January 2016 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Circadian phase [ Time Frame: 1 week ] [ Designated as safety issue: No ] Circadian phase as ascertained through salivary melatonin concentrations |
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01119365 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 |
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Bright Light as a Countermeasure for Circadian Desynchrony | ||||
| Official Title ICMJE | Bright Light as a Countermeasure for Circadian Desynchrony | ||||
| Brief Summary | 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. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
||||
| Condition ICMJE | Healthy | ||||
| Intervention ICMJE | Other: Bright light
Bright (1000 lux) light |
||||
| Study Arm (s) | Experimental: Light
Bright light
Intervention: Other: Bright light |
||||
| Publications * |
|
||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 80 | ||||
| Estimated Completion Date | June 2016 | ||||
| Estimated Primary Completion Date | January 2016 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years to 35 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01119365 | ||||
| Other Study ID Numbers ICMJE | 10165 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System | ||||
| Study Sponsor ICMJE | VA Palo Alto Health Care System | ||||
| Collaborators ICMJE |
|
||||
| Investigators ICMJE |
|
||||
| Information Provided By | VA Palo Alto Health Care System | ||||
| Verification Date | June 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||