Clinical trial NCT02483559: Seeing the World Through Assorted Glasses
Official title: Seeing the World Through Assorted Glasses (SWAG)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Keywords: Sleep
Photoreceptor Cells, Vertebrate
Melatonin
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2015-06-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Increase dim-light melatonin production
timeFrame: 4 days
Secondary outcomes:
measure: Improved subjective self-reported mood
timeFrame: 4 days
measure: Improved objective measures of sleep
timeFrame: 4 days
measure: Improved subjective self-reported sleep quality
timeFrame: 4 days
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Eric Youngstrom, PhD
role: PRINCIPAL_INVESTIGATOR
References: