Seeing the World Through Assorted Glasses

Sleep Clinical Trial

— SWAG  

Official title:

Seeing the World Through Assorted Glasses (SWAG)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02483559
• Other study ID #: 15-0389
• Status: Completed
• Phase: N/A
• First received: June 13, 2015
• Last updated: February 6, 2017
• Start date: June 2015
• Est. completion date: May 2016

Study information

• Verified date: February 2017
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep

Intervention

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

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Improved subjective self-reported mood	Participants will complete the Positive and Negative Affect Scale (PANAS) on a daily basis to measure self-reported mood.	4 days
Secondary	Improved objective measures of sleep	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.	4 days
Secondary	Improved subjective self-reported sleep quality	Participants will complete the Leeds Sleep Evaluation in order to assess self-report of sleep quality.	4 days