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Completed

NCT Number: NCT02483559

Seeing the World Through Assorted Glasses

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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

About this study

Participants will complete a self-report battery containing measures of sleep quality, morningness-eveningness chronotype, and mood. Participants will then wear a wrist-worn accelerometer for 14 days to objectively record activity level and sleep quality. Participants will also fill out a daily sleep log and short self-report measures assessing sleep and mood. On days 4-7 and 11-14 of the study the participants will wear either amber or placebo control lenses prior to sleep onset in a randomized crossover design (i.e., participants will be randomized to wear either amber lenses or placebo lenses for the first part of the protocol and then switch to wear the opposite lenses for the second part of the protocol). Participants will spend nights 7 and 14 of the study in a sleep laboratory in order to obtain hourly melatonin samples and wear a wrist sleep monitor to non-invasively and objectively measure sleep state and quality using peripheral arterial tone and oxygen perfusion.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

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.

Placebo Lenses

Other

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

Primary outcomes

  1. Increase dim-light melatonin production

    Time frame: 4 days

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

Secondary outcomes

  1. Improved subjective self-reported mood

    Time frame: 4 days

    Participants will complete the Positive and Negative Affect Scale (PANAS) on a daily basis to measure self-reported mood.

  2. Improved objective measures of sleep

    Time frame: 4 days

    Participants will complete nights in the sleep lab while wearing a watch device to measure arterial tone in order to objectively measure time spent in different sleep stages.

  3. Improved subjective self-reported sleep quality

    Time frame: 4 days

    Participants will complete the Leeds Sleep Evaluation in order to assess self-report of sleep quality.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

Seeing the World Through Assorted Glasses (SWAG)

Acronym: SWAG

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 29, 2015
Registry last updated
Feb 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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