Seeing the World Through Assorted Glasses

NCT02483559 | Completed

• 1 other identifier: 15-0389
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to test the use of amber glasses at night as a method to block blue light from the eye, allowing the brain to produce a dim-light melatonin onset. The investigators hypothesize that blue-blocking will produce measurable benefits in subjectively and objectively rated sleep quality and mood as well as salivary melatonin levels during the night.

Conditions

Sleep

Keywords

Sleep; Photoreceptor Cells, Vertebrate; Melatonin

Outcome Measures

Primary Outcomes (1)

• Increase dim-light melatonin production

  Hourly saliva samples will be collected from participants at the end of each 4 night interval in order to measure levels of melatonin production.

  4 days

Secondary Outcomes (3)

• Improved subjective self-reported mood

  4 days

• Improved objective measures of sleep

  4 days

• Improved subjective self-reported sleep quality

  4 days

Study Arms (2)

Amber Lenses

OTHER

Participants will be randomized to participate in the amber lens condition first or second. Outcome measures to assess the effects of wearing amber lenses to block the blue light spectrum of light includes mood and sleep rating questionnaires (Positive and Negative Affect Scale, PANAS; Leeds Sleep Evaluation Questionnaire) as well as measuring the levels of melatonin the body is producing while wearing the glasses.

Other: Amber Lenses

Placebo Lenses

OTHER

Participants will be randomized to participate in the placebo lens condition first or second. Outcome measures to assess the effects of wearing placebo lenses to allow all spectrums of light includes mood and sleep rating questionnaires (Positive and Negative Affect Scale, PANAS; Leeds Sleep Evaluation Questionnaire) as well as measuring the levels of melatonin the body is producing while wearing the glasses.

Other: Placebo Lenses

Interventions

Amber Lenses OTHER

Glasses fitted with amber lenses that block the blue spectrum of light (\~470 nm) to be worn prior to desired sleep onset time.

Amber Lenses

Placebo Lenses OTHER

Glasses fitted with placebo lenses that allow all visible spectrum of light to be worn prior to desired sleep onset time.

Placebo Lenses

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Good physical health
• Proficiency in written and spoken English
• Reported average total sleep time \<9 hours (so nights spent in sleep lab will not result in sleep deprivation)

You may not qualify if:

• Taking regular medication affecting sleep and/or mood
• Travel across more than two time zones within the past month
• Smoke \> 5 cigarettes per day
• Excessive caffeine use (\>2 cups at one time or \>500 mg daily)
• No current Axis I Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Disorder
• No current use of street drugs
• No history of sleep disorder/bipolar disorder/psychosis/seizure disorder/chronic medical condition
• Night shift work within the past 2 months

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Study Officials

• Eric Youngstrom, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology and Psychiatry

Study Record Dates

• First Submitted: June 13, 2015
• First Posted: June 29, 2015
• Study Start: June 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: February 8, 2017

Record last verified: 2017-02

Locations

US (1)