Investigating the Effects of Evening Light Exposure on Melatonin Suppression, Alertness and Nocturnal Sleep

This study has been completed.
Sponsor:
Collaborator:
Biological Illumination LCC
Information provided by (Responsible Party):
Steven W. Lockley, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01586039
First received: April 24, 2012
Last updated: August 8, 2014
Last verified: August 2014
  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:

  1. Less melatonin suppression between melatonin onset and bedtime;
  2. Less subjective and objective alerting responses before bedtime;
  3. Less disruption of nocturnal sleep structure and quality.

Condition Intervention
Non-visual Photoreception
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.

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Melatonin suppression [ Time Frame: 1-year from the completion of the last study participant. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 36
Study Start Date: August 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (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).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01586039

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Biological Illumination LCC
Investigators
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: August 8, 2014
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:
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014