Investigating the Effects of Evening Light Exposure on Melatonin Suppression, Alertness and Nocturnal Sleep
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Purpose
The timing and quality of sleep is governed by environmental and physiologic factors. Environmental factors, especially ambient lighting can impact the circadian system and alter the timing and structure of sleep. Light exposure can also acutely alter neural activation state and impair sleep. These effects all demonstrate marked sensitivity to short-wavelength blue light with maximal sensitivity in the 460-480 nm range. The alerting effects of blue light in the evening persist for at least 3-4 hours after the lights are turned off, and can disturb subsequent sleep. Avoiding these deleterious effects of light exposure prior to sleep on subsequent sleep would be beneficial to sleep quality and potentially health.
The investigators will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light. The investigators will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL). In a within-subject design, the investigators will test the hypotheses that exposure as compared to a CFL 90 lux exposure 90 lux of the blue-depleted LED will cause significantly:
- Less melatonin suppression between melatonin onset and bedtime;
- Less subjective and objective alerting responses before bedtime;
- Less disruption of nocturnal sleep structure and quality.
| Condition | Intervention |
|---|---|
|
Melatonin Suppression |
Radiation: Visible light |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science |
| Official Title: | Investigating the Effects of Evening Light Exposure on Melatonin Suppression, Alertness and Nocturnal Sleep. |
- Melatonin suppression [ Time Frame: 1-year from the completion of the last study participant. ] [ Designated as safety issue: No ]
- Sleep structure and quality [ Time Frame: 2-year from the completion of the last study participant. ] [ Designated as safety issue: No ]
- Subjective and objective alerting response [ Time Frame: 2-year from the completion of the last study participant. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Compact Fluorescent Light |
Radiation: Visible light
We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
|
| Experimental: Blue-depleted LED light |
Radiation: Visible light
We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
|
Eligibility| Ages Eligible for Study: | 18 Years to 30 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
(i) Aged between 18-30 years to reduce the confounding effects of lens aging on the transmission of light to the retina;
(ii) Non-smoking for at least 6 months;
(iii) Healthy (no medical, psychiatric or sleep disorders);
(iv) No clinically significant deviations from normal in medical history, vital signs, physical examination, blood chemistry and hematology, urine chemistry and ECG;
(v) Women of childbearing potential must agree to use an acceptable method of birth control, and must have a negative urine pregnancy test;
(vi) Body mass index of > 18 or < 30 kg/m2;
(vii) No drugs or medication likely to affect sleep or alertness, as determined by the investigators;
(viii) Habitual caffeine consumption < 300mg per day on average;
(ix) Habitual alcohol consumption < 10 alcoholic units per week on average.
Exclusion Criteria:
(i) History of alcohol or substance abuse;
(ii) Positive result on drugs of abuse screening;
(iii) Current or past history of sleep disorders, including but not limited to obstructive sleep apnea, or any significant sleep complaint;
(iv) Psychiatric disorder;
(v) Recent acute or chronic medical disorder, including but not limited to hepatic impairment and severe chronic obstructive pulmonary disease;
(vi) Visual disorder, including but not limited to color blindness, or family history of glaucoma;
(vii) History of intolerance or hypersensitivity to melatonin or melatonin agonists;
(viii) Pregnancy or lactation;
(ix) Shift work;
(x) Transmeridian travel (2 or more time zones) in past 2 months;
(xi) Any other reason as determined by the Principal Investigator.
Contacts and Locations| Contact: Ralph A Todesco | 6177325875 | RTODESCO@PARTNERS.ORG |
| United States, Massachusetts | |
| Brigham and Women's Hospital | Not yet recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Ralph A Todesco | |
| Principal Investigator: Steven W Lockley, Ph.D. | |
| Principal Investigator: | Steven W Lockley, Ph.D. | Brigham and Women's Hospital; Harvard Medical School |
More Information
No publications provided
| Responsible Party: | Steven W. Lockley, Associate Professor of Medicine, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT01586039 History of Changes |
| Other Study ID Numbers: | 2011-P-002834 |
| Study First Received: | April 24, 2012 |
| Last Updated: | April 25, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Brigham and Women's Hospital:
|
Melatonin Sleep Light Alertness Circadian Rhythms |
Additional relevant MeSH terms:
|
Vision, Low Vision Disorders Sensation Disorders Neurologic Manifestations Nervous System Diseases Eye Diseases Signs and Symptoms Melatonin |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on June 17, 2013