MelatoninNCT02936674
Color-dependent Melatonin Suppression
A study testing Light - standard and Light - alternate in people with Melatonin, run by VA Palo Alto Health Care System at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of complex, broad-band spectra light on the production of melatonin in humans. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Melatonin
- What is being tested?
- Light - standard and Light - alternate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Jun 2017
- 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
- Stable health
- Normal color vision
- Normal hearing
- 18-35 years old
Who cannot join
- Significant depressive symptoms
- Pregnant or nursing
- Ocular pathologies
- Unstable or severe medical or psychiatric condition
- Extreme morning/evening type
- Regular smoker
Show all 10Show fewer
- Use of medications that impact ocular function
- Alcohol use disorder
- Use of illegal drugs
- Irregular use of antihistamines, antidepressants, or sleeping medications
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 the effects of complex, broad-band spectra light on the production of melatonin in humans.
- Conditions
- Melatonin
- Being tested
- Light - standard, Light - alternate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light - standardDevice
Light will be given during the night to determine its effects on melatonin suppression. This light will be an LED with standard spectral distribution
Light - alternateDevice
Light will be given during the night to determine its effects on melatonin suppression. This light will be an LED with an altered spectral distribution (different color)
| Study group | Role | What they receive |
|---|---|---|
| Light 1 | Experimental | Light 1 will have an altered color composition as compared with a standard LED bulb. Receives: Device: Light - alternate |
| Light 2 | Active comparator | Light 2 will be a standard LED bulb. Receives: Device: Light - standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melatonin suppression
The amount of declination of salivary melatonin concentrations between the start of the light and the end of the light (4 hours later) will be compared between the conditions.
Measured: 4 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelatoninStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Palo Alto Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936674
- Sponsor's protocol ID
- IRB-10165
- Status last verified
- Jan 2018
- First submitted
- 7 Oct 2016
- Last updated
- 5 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: All relevant individual data will be published.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Color-dependent Melatonin Suppression
- ClinicalTrials.gov ID
- NCT02936674
- Acronym / sponsor ID
- IRB-10165
- Conditions
- Melatonin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- VA Palo Alto Health Care SystemUS federal agency
- Study start
- Oct 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 18 Oct 2016 (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 this study is to examine the effects of complex, broad-band spectra light on the production of melatonin in humans.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Light 1 | Experimental | Device: Light - alternateLight 1 will have an altered color composition as compared with a standard LED bulb. |
| Light 2 | Active comparator | Device: Light - standardLight 2 will be a standard LED bulb. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Stable health
- Normal color vision
- Normal hearing
- 18-35 years old
Key exclusion criteria (10 listed)
- Significant depressive symptoms
- Pregnant or nursing
- Ocular pathologies
- Unstable or severe medical or psychiatric condition
- Extreme morning/evening type
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 |
|---|---|---|
| Light - standardLight will be given during the night to determine its effects on melatonin suppression. This light will be an LED with standard spectral distribution | Device | Light 2 |
| Light - alternateLight will be given during the night to determine its effects on melatonin suppression. This light will be an LED with an altered spectral distribution (different color) | Device | Light 1 |
Primary outcome
Melatonin suppression
Time frame: 4 Hours
The amount of declination of salivary melatonin concentrations between the start of the light and the end of the light (4 hours later) will be compared between the conditions.
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 5 Jan 2018.
- Individual participant dataSharing planned: Yes. All relevant individual data will be published.
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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.
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 - standard and Light - alternate in people with Melatonin, 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 4 inclusion and 10 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 5 Jan 2018. 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?
Melatonin suppression (time frame: 4 Hours). 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 5 Jan 2018.