Chronobiology DisordersNCT01327040
Light Sensitization Study
A study testing light exposure in people with Chronobiology Disorders and Circadian Rhythm Disorders, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Circadian rhythm disorders are a class of sleep disorders characterized by misalignment between the timing of sleep and the timing of rhythms driven by the biological clock. Light therapy can effectively treat these disorders, but the intensity and duration of light exposure required to do so has limited its practical… Read more about this study
- Who is it for?
- Ages 21 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronobiology Disorders, Circadian Rhythm Disorders, Sleep Disorders, Circadian Rhythm
- What is being tested?
- light exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Dec 2020
- 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 21 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy adults with conventional and regular sleep-wake timing
- non-smokers
- completion of medical, psychological, ophthalmological, and sleep screening tests
- able to spend 13 consecutive days/nights in the laboratory
Who cannot join
- history of neurological or psychiatric disorder
- history of eye injury, eye surgery, or visual disorder (corrective lenses are acceptable)
- history of sleep disorder or regular use of sleep-promoting medication
- current prescription, herbal, or over-the-counter medication use (oral contraceptives are acceptable)
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Sensitization of Human Circadian Responses to Light
Circadian rhythm disorders are a class of sleep disorders characterized by misalignment between the timing of sleep and the timing of rhythms driven by the biological clock. Light therapy can effectively treat these disorders, but the intensity and duration of light exposure required to do so has limited its practical use. In this study the investigators will test whether pre-exposure to dim light may enhance the response of the circadian system to light therapy. If so, this could result in shorter treatments that would have greater practical applications.
Read the detailed description
Sleep disorders affect 35-40% of adults, resulting in diminished quality of life, and increased morbidity, mortality, and risk of automobile and occupational accidents. Circadian rhythm sleep disorders form a distinct class of sleep disorders characterized by misalignment between the timing of sleep and the circadian pacemaker. While light therapy can be an effective treatment of circadian rhythm sleep disorders, there are numerous practical limitations.
Light is the most powerful signal from the environment that influences and regulates daily biological rhythms. It is well-established that the irradiance, duration, and timing of light exposure all affect the response of the circadian system. While it was once thought that these responses were mediated through the visual system, it is now known that there is a network of intrinsically photosensitive retinal ganglion cells (ipRGCs) that mediate circadian responses to light. Other new studies have demonstrated that recent light exposure history affects the circadian response to light in humans.
These recent findings have important implications for the use of light to treat circadian rhythm disorders, including delayed and advanced sleep phase disorders, shift work sleep disorder, and jet lag, and they may also have relevance for the use of light to treat seasonal affective disorder. Up to now, little attention has been paid to the duration or intensity of light exposure prior to such light treatments. The investigators now have evidence that the human circadian system can become desensitized to light during long exposures and evidence that it can be sensitized to light by prior exposure to dim light. These recent findings suggest that light treatment protocols that sensitize the circadian system prior to the light treatment will be more effective than those currently in use.
The 13-day inpatient studies the investigators propose will examine the effect on the human circadian system of different durations of dim-light sensitization prior to a standardized light treatment. These results will be compared within subjects in a randomized cross-over design study in which each subject will receive a control treatment and a light treatment with prior dim-light sensitization. The investigators will also include circadian phase disorder patients to test these mechanisms in the target patient population. Our findings will provide an important step in understanding how new knowledge about the circadian photoreceptive system can be used to refine and provide better treatment options for circadian rhythm disorders.
- Being tested
- light exposure
- Keywords
- light, melatonin, circadian, delayed sleep phase disorder, circadian light sensitivity, circadian timing system
- Medical subject headings
- Chronobiology Disorders, Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
light exposureOther
12-hour light exposure of approximately 200 lux
| Study group | Role | What they receive |
|---|---|---|
| sensitization duration 1.375h | Experimental | This group will experience a 1.375h sensitization duration prior to the 12h light exposure Receives: Other: light exposure |
| sensitization duration 5.5h | Experimental | This group will experience a 5.5h sensitization duration prior to the 12h light exposure Receives: Other: light exposure |
| sensitization duration 22h | Experimental | This group will experience a 22h sensitization duration prior to the 12h light exposure Receives: Other: light exposure |
| sensitization duration 0.33h | Experimental | This group will experience a 0.33h sensitization duration prior to the 12h light exposure Receives: Other: light exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
circadian phase timing
timing of circadian phase as assessed using melatonin and temperature data
Measured: During inpatient study, on days 6-7 and 11-12
Secondary outcomes (1)
melatonin suppression
percent of melatonin suppression
Measured: During inpatient study, on days 6-7 and 11-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2011 (estimated)
- Study startOct 2010
- Primary completionDec 2015
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronobiology 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jeanne Duffy, Brigham and Women's Hospital
- Investigators
- Charles A Czeisler, PhD, MD, Principal investigator, Brigham and Women's HospitalJeanne F Duffy, PhD, Study director, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01327040
- Sponsor's protocol ID
- 2010-P-000346
- Other IDs
- R01HL094654
- Status last verified
- Jun 2021
- First submitted
- 30 Mar 2011
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitization of Human Circadian Responses to Light
- ClinicalTrials.gov ID
- NCT01327040
- Acronym / sponsor ID
- 2010-P-000346
- Keywords
- light, melatonin, circadian, delayed sleep phase disorder, circadian light sensitivity, circadian timing system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 1 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.
Circadian rhythm disorders are a class of sleep disorders characterized by misalignment between the timing of sleep and the timing of rhythms driven by the biological clock. Light therapy can effectively treat these disorders, but the intensity and duration of light exposure required to do so has limited its practical use. In this study the investigators will test whether pre-exposure to dim light may enhance the response of the circadian system to light therapy. If so, this could result in shorter treatments that would have greater practical applications.
Detailed description
Sleep disorders affect 35-40% of adults, resulting in diminished quality of life, and increased morbidity, mortality, and risk of automobile and occupational accidents. Circadian rhythm sleep disorders form a distinct class of sleep disorders characterized by misalignment between the timing of sleep and the circadian pacemaker. While light therapy can be an effective treatment of circadian rhythm sleep disorders, there are numerous practical limitations.
Light is the most powerful signal from the environment that influences and regulates daily biological rhythms. It is well-established that the irradiance, duration, and timing of light exposure all affect the response of the circadian system. While it was once thought that these responses were mediated through the visual system, it is now known that there is a network of intrinsically photosensitive retinal ganglion cells (ipRGCs) that mediate circadian responses to light. Other new studies have demonstrated that recent light exposure history affects the circadian response to light in humans.
These recent findings have important implications for the use of light to treat circadian rhythm disorders, including delayed and advanced sleep phase disorders, shift work sleep disorder, and jet lag, and they may also have relevance for the use of light to treat seasonal affective disorder. Up to now, little attention has been paid to the duration or intensity of light exposure prior to such light treatments. The investigators now have evidence that the human circadian system can become desensitized to light during long exposures and evidence that it can be sensitized to light by prior exposure to dim light. These recent findings suggest that light treatment protocols that sensitize the circadian system prior to the light treatment will be more effective than those currently in use.
The 13-day inpatient studies the investigators propose will examine the effect on the human circadian system of different durations of dim-light sensitization prior to a standardized light treatment. These results will be compared within subjects in a randomized cross-over design study in which each subject will receive a control treatment and a light treatment with prior dim-light sensitization. The investigators will also include circadian phase disorder patients to test these mechanisms in the target patient population. Our findings will provide an important step in understanding how new knowledge about the circadian photoreceptive system can be used to refine and provide better treatment options for circadian rhythm disorders.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| sensitization duration 1.375h | Experimental | Other: light exposureThis group will experience a 1.375h sensitization duration prior to the 12h light exposure |
| sensitization duration 5.5h | Experimental | Other: light exposureThis group will experience a 5.5h sensitization duration prior to the 12h light exposure |
| sensitization duration 22h | Experimental | Other: light exposureThis group will experience a 22h sensitization duration prior to the 12h light exposure |
| sensitization duration 0.33h | Experimental | Other: light exposureThis group will experience a 0.33h sensitization duration prior to the 12h light exposure |
Who may qualify
- Ages
- 21 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy adults with conventional and regular sleep-wake timing
- non-smokers
- completion of medical, psychological, ophthalmological, and sleep screening tests
- able to spend 13 consecutive days/nights in the laboratory
Key exclusion criteria (4 listed)
- history of neurological or psychiatric disorder
- history of eye injury, eye surgery, or visual disorder (corrective lenses are acceptable)
- history of sleep disorder or regular use of sleep-promoting medication
- current prescription, herbal, or over-the-counter medication use (oral contraceptives are acceptable)
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 exposure12-hour light exposure of approximately 200 lux | Other | sensitization duration 0.33h, sensitization duration 1.375h, sensitization duration 22h, sensitization duration 5.5h |
Primary outcome
circadian phase timing
Time frame: During inpatient study, on days 6-7 and 11-12
timing of circadian phase as assessed using melatonin and temperature data
1 secondary outcome
melatonin suppression
Time frame: During inpatient study, on days 6-7 and 11-12
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 1 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Charles A Czeisler, PhD, MD principal investigator
Brigham and Women's Hospital
Jeanne F Duffy, PhD study director
Brigham and Women's Hospital
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 exposure in people with Chronobiology Disorders and 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 4 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 1 Jul 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. 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 timing (time frame: During inpatient study, on days 6-7 and 11-12). 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 1 Jul 2021.