Circadian Rhythm DisordersNCT01330992
Human Circadian Sensitivity to Very Short Light Pulses
A study testing Ocular light or darkness exposure in people with Circadian Rhythm Disorders, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The mammalian eye serves both visual and non-image-forming functions. New information about the non-image-forming anatomy and physiology of the eye has revealed effects of ocular light stimuli on human circadian rhythms, melatonin suppression, heart rate, pupillary reflexes, cognitive performance, alertness and sleep. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Circadian Rhythm Disorders
- What is being tested?
- Ocular light or darkness exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Aug 2011
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers
Who cannot join
- No medications
- No eye disease
- No sleep disorders
- No psychiatric disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
The mammalian eye serves both visual and non-image-forming functions. New information about the non-image-forming anatomy and physiology of the eye has revealed effects of ocular light stimuli on human circadian rhythms, melatonin suppression, heart rate, pupillary reflexes, cognitive performance, alertness and sleep. The results of the proposed work can be used to make predictions about the effects of light, to make recommendations involving exposure to or avoidance of light, and to design environmental lighting, resulting in improved health and alertness and decreased errors and accidents.
- Conditions
- Circadian Rhythm Disorders
- Being tested
- Ocular light or darkness exposure
- Keywords
- Circadian rhythms, Melatonin, Ocular light exposure, Darkness Exposure, Performance, Alertness
- Medical subject headings
- Chronobiology Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocular light or darkness exposureOther
Ocular light or darkness exposure
| Study group | Role | What they receive |
|---|---|---|
| Ocular Light or Dark Exposure | Experimental | Ocular Light or Dark Exposure Receives: Other: Ocular light or darkness exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circadian Phase (hours)
Circadian phase (hours) measured before and after intervention
Measured: Before and after intervention (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2011 (estimated)
- Study startDec 2009
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circadian Rhythm DisordersStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth B. Klerman, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330992
- Sponsor's protocol ID
- NIH-RC2-HL101340
- Status last verified
- Aug 2011
- First submitted
- 1 Apr 2011
- Last updated
- 23 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Circadian Sensitivity to Very Short Light Pulses
- ClinicalTrials.gov ID
- NCT01330992
- Acronym / sponsor ID
- NIH-RC2-HL101340
- Conditions
- Circadian Rhythm Disorders
- Keywords
- Circadian rhythms, Melatonin, Ocular light exposure, Darkness Exposure, Performance, Alertness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 7 Apr 2011 (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 mammalian eye serves both visual and non-image-forming functions. New information about the non-image-forming anatomy and physiology of the eye has revealed effects of ocular light stimuli on human circadian rhythms, melatonin suppression, heart rate, pupillary reflexes, cognitive performance, alertness and sleep. The results of the proposed work can be used to make predictions about the effects of light, to make recommendations involving exposure to or avoidance of light, and to design environmental lighting, resulting in improved health and alertness and decreased errors and accidents.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ocular Light or Dark Exposure | Experimental | Other: Ocular light or darkness exposureOcular Light or Dark Exposure |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteers
Key exclusion criteria (4 listed)
- No medications
- No eye disease
- No sleep disorders
- No psychiatric disorders
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 |
|---|---|---|
| Ocular light or darkness exposureOcular light or darkness exposure | Other | Ocular Light or Dark Exposure |
Primary outcome
Circadian Phase (hours)
Time frame: Before and after intervention (day 1)
Circadian phase (hours) measured before and after intervention
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 23 Aug 2011.
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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 Ocular light or darkness exposure in people with Circadian Rhythm Disorders, run by Brigham and Women's Hospital 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 1 inclusion and 4 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 23 Aug 2011. 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?
Circadian Phase (hours) (time frame: Before and after intervention (day 1)). 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 23 Aug 2011.