SleepSWAGNCT02483559
Seeing the World Through Assorted Glasses
A study testing Amber Lenses in people with Sleep, run by University of North Carolina, Chapel Hill at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Amber Lenses
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
Official title: Seeing the World Through Assorted Glasses (SWAG)
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.
Read the 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
- Being tested
- Amber Lenses, Placebo Lenses
- Keywords
- Sleep, Photoreceptor Cells, Vertebrate, Melatonin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amber LensesOther
Glasses fitted with amber lenses that block the blue spectrum of light (~470 nm) to be worn prior to desired sleep onset time.
Placebo LensesOther
Glasses fitted with placebo lenses that allow all visible spectrum of light to be worn prior to desired sleep onset time.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo Lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 days
Secondary outcomes (3)
Improved subjective self-reported mood
Participants will complete the Positive and Negative Affect Scale (PANAS) on a daily basis to measure self-reported mood.
Measured: 4 days
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.
Measured: 4 days
Improved subjective self-reported sleep quality
Participants will complete the Leeds Sleep Evaluation in order to assess self-report of sleep quality.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Youngstrom, PhD, University of North Carolina, Chapel Hill
- Investigators
- Eric Youngstrom, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483559
- Sponsor's protocol ID
- 15-0389
- Acronym
- SWAG
- Status last verified
- Feb 2017
- First submitted
- 13 Jun 2015
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seeing the World Through Assorted Glasses (SWAG)
- ClinicalTrials.gov ID
- NCT02483559
- Acronym / sponsor ID
- SWAG / 15-0389
- Conditions
- Sleep
- Keywords
- Sleep, Photoreceptor Cells, Vertebrate, Melatonin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 29 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amber Lenses | Other | Other: Amber LensesParticipants 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. |
| Placebo Lenses | Other | Other: Placebo LensesParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amber LensesGlasses fitted with amber lenses that block the blue spectrum of light (~470 nm) to be worn prior to desired sleep onset time. | Other | Amber Lenses |
| Placebo LensesGlasses fitted with placebo lenses that allow all visible spectrum of light to be worn prior to desired sleep onset time. | Other | Placebo Lenses |
Primary outcome
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.
3 secondary outcomes
Improved subjective self-reported mood
Time frame: 4 days
Improved objective measures of sleep
Time frame: 4 days
Improved subjective self-reported sleep quality
Time frame: 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Youngstrom, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amber Lenses in people with Sleep, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase dim-light melatonin production (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2017.