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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00200863
Other study ID # R01AT002129-01
Secondary ID R01AT002129-01
Status Completed
Phase N/A
First received September 12, 2005
Last updated August 8, 2014
Start date April 2005
Est. completion date February 2007

Study information

Verified date August 2014
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date February 2007
Est. primary completion date February 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria:

- Free from any acute, chronic or debilitating medical, psychological, or ophthalmological conditions

- Drug-free (including caffeine, nicotine, and alcohol) for entire study duration

Exclusion Criteria:

- History of drug or alcohol dependency

- History of psychiatric illnesses or evidence of psychopathology according to standardized questionnaires, or in a structured clinical interview

- Night shift work during the past 3 years

- Transmeridian travel in the last 3 months

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Monochromatic visible light exposure
Monochromatic light in the visible range from 420-620 nm up to 60uW/cm2 for 6.5 hours

Locations

Country Name City State
United States Division of Sleep Medicine, Brigham and Women's Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Brigham and Women's Hospital National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Subjective alertness prior to, during and after light exposure 9.5 hours No
Primary Auditory psychomotor performance prior to, during and after light exposure 9.5 hours No
Primary EEG power frequency prior to, during and after light exposure 9.5 hours No
Primary Plasma melatonin and cortisol prior to, during and after light exposure 60 hours No
Primary Heart rate, blood pressure, respiration rate and temperature prior to, during and after light exposure 9.5 hours No
Primary Urinary catecholamines prior to, during and after light exposure 32 hours No
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