Human Circadian Sensitivity to Very Short Light Pulses

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01330992
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Arm: 1
• Duration (Months): 20
• Patients Per Site Per Month: 20

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Circadian Rhythm Disorders	Other: Ocular light or darkness exposure	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Human Circadian Sensitivity to Very Short Light Pulses
• Study Start Date: Dec 1, 2009
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ocular Light or Dark Exposure Ocular Light or Dark Exposure	Other: Ocular light or darkness exposure; Ocular light or darkness exposure

Outcome Measures

Primary Outcome Measures

1. Circadian Phase (hours) [Before and after intervention (day 1)]

   Circadian phase (hours) measured before and after intervention

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy volunteers

Exclusion Criteria:

• No medications

• No eye disease

• No sleep disorders

• No psychiatric disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Brigham and Women's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Elizabeth B. Klerman, Associate Professor, Associate Physician, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT01330992
• Other Study ID Numbers: NIH-RC2-HL101340
• First Posted: Apr 7, 2011
• Last Update Posted: Aug 23, 2011
• Last Verified: Aug 1, 2011

• Keywords provided by Elizabeth B. Klerman, Associate Professor, Associate Physician, Brigham and Women's Hospital: Circadian rhythms; Melatonin; Ocular light exposure; Darkness Exposure; Performance; Alertness
• Additional relevant MeSH terms: Chronobiology Disorders

Study Results

No Results Posted as of Aug 23, 2011