NCT01330992

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

August 23, 2011

Status Verified

August 1, 2011

Enrollment Period

1.7 years

First QC Date

April 1, 2011

Last Update Submit

August 19, 2011

Conditions

Circadian Rhythm Disorders

Keywords

Circadian rhythmsMelatoninOcular light exposureDarkness ExposurePerformanceAlertness

Outcome Measures

Primary Outcomes (1)

  • Circadian Phase (hours)

    Circadian phase (hours) measured before and after intervention

    Before and after intervention (day 1)

Study Arms (1)

Ocular Light or Dark Exposure

EXPERIMENTAL

Ocular Light or Dark Exposure

Other: Ocular light or darkness exposure

Interventions

Ocular light or darkness exposureOTHER

Ocular light or darkness exposure

Ocular Light or Dark Exposure

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers

You may not qualify if:

  • No medications
  • No eye disease
  • No sleep disorders
  • No psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Chronobiology Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Associate Physician

Study Record Dates

First Submitted

April 1, 2011

First Posted

April 7, 2011

Study Start

December 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

August 23, 2011

Record last verified: 2011-08

Locations

US(1)