Seeing the World Through Assorted Glasses

NCT ID: NCT02483559

Last Updated: 2017-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-05-31

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.

Conditions

Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Amber Lenses

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.

Group Type: OTHER

Amber Lenses

Intervention Type: 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

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.

Group Type: OTHER

Placebo Lenses

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Placebo Lenses

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Eric Youngstrom, PhD

Professor of Psychology and Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric Youngstrom, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

15-0389

Identifier Type: -

Identifier Source: org_study_id