Sleep Length and Circadian Regulation in Humans
HAM
1 other identifier
interventional
16
1 country
1
Brief Summary
This research will examine why sleep restriction reduces the body clock's response to bright light. The results will enable the optimization of the bright light treatment of people who suffer from circadian rhythm sleep disorders, which include shift work sleep disorder, jet lag, delayed sleep phase syndrome and winter depression, thereby improving public health and safety, well-being, mood, mental function, and quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2008
Longer than P75 for not_applicable
1 active site
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
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 12, 2009
CompletedFirst Posted
Study publicly available on registry
February 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedResults Posted
Study results publicly available
March 8, 2016
CompletedMarch 8, 2016
February 1, 2016
5.9 years
February 12, 2009
November 2, 2015
February 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dim Light Melatonin Onset (Hours)
Gold standard marker of circadian timing
12 days from baseline to final dim light melatonin onset
Secondary Outcomes (1)
Psychomotor Vigilance
after short or long nights
Study Arms (2)
9 hour sleep, then 3 hour nap and 6 hour sleep
ACTIVE COMPARATOR3 hour nap and 6 hour sleep, then 9 hour sleep
ACTIVE COMPARATORInterventions
Bright light of about 5000 lux, administered while sitting at a desk.
Eligibility Criteria
You may qualify if:
- healthy adult volunteers
You may not qualify if:
- color blindness with the Ishihara test
- obese people (BMI \> 30)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Biological Rhythms Research Laboratory, RUMC
Chicago, Illinois, 60612, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Helen Burgess
- Organization
- Rush University Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Helen Burgess, PhD
Rush University Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 12, 2009
First Posted
February 13, 2009
Study Start
March 1, 2008
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
March 8, 2016
Results First Posted
March 8, 2016
Record last verified: 2016-02