SleepNCT03636360
The Impact of Artificial Sunlight on Human Sleep and Circadian Rhythms
A study testing Light in people with Sleep and Circadian Dysregulation, run by VA Palo Alto Health Care System at 1 site in United States.
Trial summary
The purpose of this study is to examine, in healthy controls, whether LED lighting that has a color spectrum similar to that of sunlight is able to differentially impact mood, circadian rhythms, sleep, and behavior, as compared to standard fluorescent lighting. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Circadian Dysregulation, Mood
- What is being tested?
- Light
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 1 Mar 2021
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good self-reported health
- Normal color vision
Who cannot join
- No sleep disorders
- No extreme chronotype
- Regular smoker
- Significant hearing loss
- Depression
- Alcohol use disorder
- Use of illegal drugs
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System
Palo Alto, California, 94304
About this study
The purpose of this study is to examine, in healthy controls, whether LED lighting that has a color spectrum similar to that of sunlight is able to differentially impact mood, circadian rhythms, sleep, and behavior, as compared to standard fluorescent lighting.
- Conditions
- Sleep, Circadian Dysregulation, Mood
- Being tested
- Light
- Medical subject headings
- Chronobiology Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LightDevice
15 hours of light exposure
| Study group | Role | What they receive |
|---|---|---|
| LED - Sunlike | Experimental | LED lighting with spectral pattern similar to that of sunlight Receives: Device: Light |
| Fluorescent | Active comparator | Fluorescent light at same illuminance (lux) as LED light Receives: Device: Light |
| Dim | Placebo comparator | Dim fluorescent light with same spectrum as "Fluorescent" condition Receives: Device: Light |
| LED | Active comparator | Standard LED lighting Receives: Device: Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alertness
Change in median reaction time score on the auditory psychomotor vigilance test
Measured: 15 hours
Melatonin suppression
Amount of reduction in the concentration of salivary melatonin concentrations during an experimental light stimulus
Measured: 3 hours
Secondary outcomes (1)
Mood
Change in total positive and negative affect scores on the Positive and Negative Affect Schedule (PANAS)
Measured: 15 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start1 Jul 2019
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
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.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Palo Alto Health Care System
- Sponsor type
- US federal agency
- Collaborators
- Seoul Semiconductor
- Responsible party
- Principal investigator, Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636360
- Sponsor's protocol ID
- Sunlike
- Status last verified
- Mar 2021
- First submitted
- 2 Aug 2018
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Artificial Sunlight on Human Sleep and Circadian Rhythms
- ClinicalTrials.gov ID
- NCT03636360
- Acronym / sponsor ID
- Sunlike
- Conditions
- Sleep, Circadian Dysregulation, Mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- VA Palo Alto Health Care SystemUS federal agency
- Collaborators
- Seoul Semiconductor
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 17 Aug 2018 (actual)
- 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 this study is to examine, in healthy controls, whether LED lighting that has a color spectrum similar to that of sunlight is able to differentially impact mood, circadian rhythms, sleep, and behavior, as compared to standard fluorescent lighting.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LED - Sunlike | Experimental | Device: LightLED lighting with spectral pattern similar to that of sunlight |
| Fluorescent | Active comparator | Device: LightFluorescent light at same illuminance (lux) as LED light |
| Dim | Placebo comparator | Device: LightDim fluorescent light with same spectrum as "Fluorescent" condition |
| LED | Active comparator | Device: LightStandard LED lighting |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Good self-reported health
- Normal color vision
Key exclusion criteria (8 listed)
- No sleep disorders
- No extreme chronotype
- Regular smoker
- Significant hearing loss
- Depression
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 |
|---|---|---|
| Light15 hours of light exposure | Device | Dim, Fluorescent, LED, LED - Sunlike |
Primary outcome
Alertness
Time frame: 15 hours
Change in median reaction time score on the auditory psychomotor vigilance test
Melatonin suppression
Time frame: 3 hours
Amount of reduction in the concentration of salivary melatonin concentrations during an experimental light stimulus
1 secondary outcome
Mood
Time frame: 15 hours
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 30 Mar 2021.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light in people with Sleep and Circadian Dysregulation, run by VA Palo Alto Health Care System 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 2 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 30 Mar 2021. 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. Some participants in this study may receive a placebo. 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?
Alertness (time frame: 15 hours). The study lists 2 primary outcomes in all. 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 30 Mar 2021.