Effects of Different Colors of Light on Human Physiology
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | January 12, 2010 | ||||
| Start Date ICMJE | January 2005 | ||||
| Estimated Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00200863 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Different Colors of Light on Human Physiology | ||||
| Official Title ICMJE | Mechanism Underlying the Effects of Blue Light in Humans | ||||
| Brief Summary | This study will determine which color of light is most effective in stimulating a range of biological functions in humans including activation of sleep-wake regulatory system (alertness, performance, microsleeps, brain activity), activation of the nervous system (heart rate, temperature, blood pressure, breathing rate), and shifting the timing of the internal 24-hour (circadian) pacemaker. |
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| Detailed Description | Light has long been proposed to have a stimulatory effect on a range of biological functions in humans including increased feelings of activation, such as improved alertness or ability to perform. The mechanisms underlying how light stimulates these neurobiological systems remain to be elucidated. We propose to investigate the effects of different colors of light on human physiology, and in particular, test the claims that specific colors of light preferentially stimulate neurobiological, physiological and hormonal systems. Using classical photobiological techniques, we will construct action spectra for the effects of different colors of light on a range of non-image forming responses in humans. We will test the hypotheses that: 1) light-induced activation of the neurobiological sleep-wake regulatory system, as indicated by increased alertness, faster reaction time, suppression of EEG alpha activity, microsleeps and slow rolling eye movements, and suppression of pineal melatonin, is most sensitive to retinal exposure to short wavelength blue light (460 nm) compared to equal photons of other colors of visible light; 2) light-induced activation of autonomic and hypothalamic-pituitary-adrenal axis measures of arousal, as indicated by increased heart rate variability, core body temperature, blood pressure, respiration rate, plasma cortisol levels and urinary catecholamines, is most sensitive to exposure to short wavelength blue light (460 nm) compared to equal photons of other colors; 3) phase shifts of the human circadian pacemaker, as assessed by changes in temperature, melatonin and cortisol rhythms, are most sensitive to exposure to short wavelength blue light (460 nm) compared to equal photons of other colors. The resultant action spectra will help to identify the photoreceptor mechanism(s) by which light activates arousal and circadian resetting, these non-image-forming physiological responses and enable us to distinguish between major candidate photoreceptive mechanisms, including potential novel photoreceptor systems, that might mediate such responses. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Device: Monochromatic visible light exposure
Monochromatic light in the visible range from 420-620 nm up to 60uW/cm2 for 6.5 hours |
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| Study Arm (s) |
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| Publications * | Gooley JJ, Chamberlain K, Smith KA, Khalsa SB, Rajaratnam SM, Van Reen E, Zeitzer JM, Czeisler CA, Lockley SW. Exposure to room light before bedtime suppresses melatonin onset and shortens melatonin duration in humans. J Clin Endocrinol Metab. 2011 Mar;96(3):E463-72. Epub 2010 Dec 30. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 48 | ||||
| Estimated Completion Date | July 2010 | ||||
| Estimated Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 30 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00200863 | ||||
| Other Study ID Numbers ICMJE | R01 AT002129-01, R01AT002129-01 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Steven W. Lockley, Ph.D., Brigham and Women's Hospital, Boston, MA | ||||
| Study Sponsor ICMJE | Brigham and Women's Hospital | ||||
| Collaborators ICMJE | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Investigators ICMJE |
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| Information Provided By | Brigham and Women's Hospital | ||||
| Verification Date | January 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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