Human Circadian Sensitivity to Very Short Light Pulses
Primary Purpose
Circadian Rhythm Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ocular light or darkness exposure
Sponsored by
About this trial
This is an interventional basic science trial for Circadian Rhythm Disorders focused on measuring Circadian rhythms, Melatonin, Ocular light exposure, Darkness Exposure, Performance, Alertness
Eligibility Criteria
Inclusion Criteria:
- Healthy volunteers
Exclusion Criteria:
- No medications
- No eye disease
- No sleep disorders
- No psychiatric disorders
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ocular Light or Dark Exposure
Arm Description
Ocular Light or Dark Exposure
Outcomes
Primary Outcome Measures
Circadian Phase (hours)
Circadian phase (hours) measured before and after intervention
Secondary Outcome Measures
Full Information
NCT ID
NCT01330992
First Posted
April 1, 2011
Last Updated
August 19, 2011
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01330992
Brief Title
Human Circadian Sensitivity to Very Short Light Pulses
Official Title
Human Circadian Sensitivity to Very Short Light Pulses
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The mammalian eye serves both visual and non-image-forming functions. New information about the non-image-forming anatomy and physiology of the eye has revealed effects of ocular light stimuli on human circadian rhythms, melatonin suppression, heart rate, pupillary reflexes, cognitive performance, alertness and sleep. The results of the proposed work can be used to make predictions about the effects of light, to make recommendations involving exposure to or avoidance of light, and to design environmental lighting, resulting in improved health and alertness and decreased errors and accidents.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Circadian Rhythm Disorders
Keywords
Circadian rhythms, Melatonin, Ocular light exposure, Darkness Exposure, Performance, Alertness
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ocular Light or Dark Exposure
Arm Type
Experimental
Arm Description
Ocular Light or Dark Exposure
Intervention Type
Other
Intervention Name(s)
Ocular light or darkness exposure
Intervention Description
Ocular light or darkness exposure
Primary Outcome Measure Information:
Title
Circadian Phase (hours)
Description
Circadian phase (hours) measured before and after intervention
Time Frame
Before and after intervention (day 1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy volunteers
Exclusion Criteria:
No medications
No eye disease
No sleep disorders
No psychiatric disorders
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Human Circadian Sensitivity to Very Short Light Pulses
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