Human Circadian Sensitivity to Very Short Light Pulses | NCT01330992

Studies
Human Circadian Sensitivity to Very Short Light Pulses

NCT01330992

Sponsor

Brigham and Women's Hospital

Status

Completed

Last Update Posted

Aug 23, 2011Estimated

Enrollment

400Estimated

Phase

Not Applicable

Conditions

Circadian Rhythm Disorders

Interventions

Ocular light or darkness exposure

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Apr 1, 2011

First Submission Date that Met QC Criteria

Apr 6, 2011

First Posted Date

Apr 7, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2011

Last Update Posted Date

Aug 23, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Elizabeth B. Klerman, Associate Professor, Associate Physician, Brigham and Women's HospitalPrincipal Investigator

Lead Sponsor

Brigham and Women's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ocular Light or Dark Exposure	Experimental	Ocular Light or Dark Exposure	Other: Ocular light or darkness exposure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ocular light or darkness exposure	Other	Ocular light or darkness exposure	Ocular Light or Dark Exposure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Circadian Phase (hours)	Circadian phase (hours) measured before and after intervention	Before and after intervention (day 1)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy volunteers

Exclusion Criteria:

No medications
No eye disease
No sleep disorders
No psychiatric disorders

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brigham and Women's Hospital		Boston	Massachusetts	02115	United States

Condition Browse Module

MeSH Terms

ID	Term
D021081	Chronobiology Disorders

Ancestor Terms

ID	Term
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided