NCT00200863

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Apr 2005

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

August 12, 2014

Status Verified

August 1, 2014

Enrollment Period

1.8 years

First QC Date

September 12, 2005

Last Update Submit

August 8, 2014

Conditions

Keywords

lightwavelengthaction spectrumcircadianmelatoninalertnessperformancearousal

Outcome Measures

Primary Outcomes (6)

  • Subjective alertness prior to, during and after light exposure

    9.5 hours

  • Auditory psychomotor performance prior to, during and after light exposure

    9.5 hours

  • EEG power frequency prior to, during and after light exposure

    9.5 hours

  • Plasma melatonin and cortisol prior to, during and after light exposure

    60 hours

  • Heart rate, blood pressure, respiration rate and temperature prior to, during and after light exposure

    9.5 hours

  • Urinary catecholamines prior to, during and after light exposure

    32 hours

Study Arms (6)

1

EXPERIMENTAL

420 nm light

Device: Monochromatic visible light exposure

2

EXPERIMENTAL

480 nm

Device: Monochromatic visible light exposure

3

EXPERIMENTAL

507 nm

Device: Monochromatic visible light exposure

4

EXPERIMENTAL

555 nm

Device: Monochromatic visible light exposure

5

EXPERIMENTAL

620 nm

Device: Monochromatic visible light exposure

6

EXPERIMENTAL

460 nm

Device: Monochromatic visible light exposure

Interventions

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

123456

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Free from any acute, chronic or debilitating medical, psychological, or ophthalmological conditions
  • Drug-free (including caffeine, nicotine, and alcohol) for entire study duration

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Sleep Medicine, Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • 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. doi: 10.1210/jc.2010-2098. Epub 2010 Dec 30.

Study Officials

  • Steven W Lockley, Ph.D.

    Brigham and Women's Hospital, Harvard Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neuroscientist

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

April 1, 2005

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

August 12, 2014

Record last verified: 2014-08

Locations