SleepNCT04882280
Dose-dependent Impact of Daytime Lighting on Evening Responses to Light
A study testing Light in people with Sleep, run by Palo Alto Veterans Institute for Research at 1 site in United States.
Trial summary
The purpose of this study is to systematically examine the impact of different intensities of daytime light and the subsequent impact that such exposure has on non-image forming responses to light in the evening. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Light
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2022to Jul 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18-65
- Good health
- Male or female
- Normal color vision
Who cannot join
- Sleep disorders
- Extreme chronotypes
- Routine smoker
- Significant hearing loss
- Depressed
- Alcohol use disorder
- Use of illegal drugs
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 systematically examine the impact of different intensities of daytime light and the subsequent impact that such exposure has on non-image forming responses to light in the evening.
- Conditions
- Sleep
- Being tested
- Light
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LightBehavioural
10 hours of light exposure during the daytime, starting 2 hours after habitual wake time
| Study group | Role | What they receive |
|---|---|---|
| Low room | Experimental | Low intensity (80 lux) room light Receives: Behavioral: Light |
| Normal room | Experimental | Normal intensity (150 lux) room light Receives: Behavioral: Light |
| Bright room | Experimental | High intensity (500 lux) room light Receives: Behavioral: Light |
| Bright | Experimental | Very high intensity (1000 lux) room light Receives: Behavioral: Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suppression of melatonin production
Difference in salivary melatonin concentrations between active arm and 3 lux control condition
Measured: 4 hours
Phase shift in the timing of melatonin onset
Change in the onset of melatonin secretion after experimental stimulus
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study startJul 2022 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJul 2024 (estimated)
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Palo Alto Veterans Institute for Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882280
- Sponsor's protocol ID
- Reverse DRC
- Status last verified
- Mar 2022
- First submitted
- 7 May 2021
- Last updated
- 17 Mar 2022
- 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 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-dependent Impact of Daytime Lighting on Evening Responses to Light
- ClinicalTrials.gov ID
- NCT04882280
- Acronym / sponsor ID
- Reverse DRC
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Palo Alto Veterans Institute for ResearchUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 11 May 2021 (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 systematically examine the impact of different intensities of daytime light and the subsequent impact that such exposure has on non-image forming responses to light in the evening.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low room | Experimental | Behavioral: LightLow intensity (80 lux) room light |
| Normal room | Experimental | Behavioral: LightNormal intensity (150 lux) room light |
| Bright room | Experimental | Behavioral: LightHigh intensity (500 lux) room light |
| Bright | Experimental | Behavioral: LightVery high intensity (1000 lux) room light |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-65
- Good health
- Male or female
- Normal color vision
Key exclusion criteria (7 listed)
- Sleep disorders
- Extreme chronotypes
- Routine smoker
- Significant hearing loss
- Depressed
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 |
|---|---|---|
| Light10 hours of light exposure during the daytime, starting 2 hours after habitual wake time | Behavioural | Bright, Bright room, Low room, Normal room |
Primary outcome
Suppression of melatonin production
Time frame: 4 hours
Difference in salivary melatonin concentrations between active arm and 3 lux control condition
Phase shift in the timing of melatonin onset
Time frame: 2 days
Change in the onset of melatonin secretion after experimental stimulus
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- 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.
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, run by Palo Alto Veterans Institute for Research 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 7 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: status not confirmed, as of the sponsor's last update on 17 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jamie Zeitzer, PhD (6504935000, jzeitzer@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suppression of melatonin production (time frame: 4 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 17 Mar 2022.