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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
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

First Posted
April 1, 2011
Last Updated
August 19, 2011
Sponsor
Brigham and Women's Hospital
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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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