SleepMars 105NCT01169233
Operational Evaluation of a Photic Countermeasure to Improve Alertness, Performance, and Mood During Nightshift Work on a 105-day Simulated Human Exploration Mission to Mars
A study testing Bright Light Box in people with Sleep and Alertness, run by Brigham and Women's Hospital at 1 site in Russia.
Trial summary
The success of human expedition missions critically depend on the ability of the crew to be alert and maintain high levels of cognitive function while operating complex, technical equipment. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- What is being tested?
- Bright Light Box
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteRussia
- Study dates
- Aug 2008to Dec 2013
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Any individual chosen by the Institute of Biomedical Problems to participate in or support the space flight simulation study was eligible to participate in the study.
Who cannot join
- None. Any individual chosen by the Institute of Biomedical Problems to participate in or support the space flight simulation study was eligible to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
The success of human expedition missions critically depend on the ability of the crew to be alert and maintain high levels of cognitive function while operating complex, technical equipment. Optimal human health, performance and safety during space flight requires sufficient sleep and synchrony between the circadian pacemaker-which regulates the timing of sleep, endocrine function, alertness and performance-and the timing of the imposed sleep-wake schedule.
Crewmembers of the 105-day simulation study will be required to work one night shift every sixth night. This schedule will likely result in sleep loss and circadian misalignment, especially when lighting conditions are similar to those that crewmembers experience during spaceflight. External mission controllers will work 24-hour shifts, also resulting in both sleep loss and circadian misalignment.
Read more
It has been well documented in laboratory and field studies that both working the night shift and working extended duration shifts result in decrement alertness, performance and mood. In addition to the negative effects that night shift work has on alertness, performance and mood, shift work causes significant short and long-term health problems. Shift workers, particularly night shift workers who invert their normal sleep/wake schedule, suffer for several reasons. First, their endogenous circadian rhythms and the imposed sleep/work schedule are typically out of phase. This is similar to the experience of jet lag. However, while environment cues (e.g., sunrise, sunset, the timing of meals and sleep) enable travelers to adapt quickly to a new time zone, crewmembers in the 105-day simulation will be unable to do so because they will only spend one night of every five working. When working the night shift, the timing of meals, work, and sleep will therefore be out of phase with the normal entrained phase of the circadian timing system. Ingestion of meals at an inappropriate circadian phase results in impaired metabolism, likely underlying the gastrointestinal and metabolic problems experienced by shift workers. Second, this circadian misalignment leads to a substantial loss of sleep efficiency during the (daytime) sleep period, independent of, and in addition to, environmental obstacles to sleep (e.g., noise, light, other crewmembers). Third, misalignment of circadian phase coupled with sleep loss will each result in deterioration of alertness and impairment of performance during the night. Since these adverse effects are particularly acute on the first night of work, the plan for crewmembers on the Mars 105 mission to work the midnight shift every sixth night will subject them repeatedly to the performance impairments associated with acute circadian misalignment and acute sleep deprivation.
Lighting Countermeasure. Our group at the Harvard Medical School has successfully developed and tested effective photic countermeasures to alleviate circadian misalignment and improve alertness, performance and mood in night shift workers. The most effective countermeasure to circadian alignment is appropriately-timed and sufficiently intense light. Light also acutely improves alertness, performance and mood. Most recently it has been reported that short wavelength light has been shown to be most effective for both resetting circadian rhythms and acutely improving performance during night work via antecedent suppression of the soporific hormone melatonin.
These photic countermeasures have been tested in individual subjects living in laboratory simulations (Countermeasures readiness level/Technology readiness level 7; Evaluation with human subjects in controlled laboratory simulating operational spaceflight environment). The next critical step is to evaluate our countermeasures in an operational simulation of space flight that includes study of the interaction among crew members in a high fidelity simulation (Countermeasures readiness level/Technology readiness level 8; Validation with human subjects in actual operational spaceflight to demonstrate efficacy and operational feasibility).
Adequate sleep and circadian alignment are critical to maintaining the health and performance of expedition mission crewmembers. Testing of the developed lighting countermeasure in a high fidelity operational environment imitating the conditions of a future expedition mission (e.g., to Mars) is critical to ensure countermeasure readiness and to reduce the risk of human performance errors due to factors related to circadian disruption, sleep loss and fatigue. Development and testing of this photic countermeasure for mission controllers working 24-hour shifts will further ensure the success of the future long duration expedition missions.
Read the detailed description
The objective and tasks of the investigation.
The purpose of this study is to validate the efficacy and operational feasibility of a photic countermeasure to improve alertness and performance during night shift work occurring during a simulated expedition mission. We propose to address the following specific aims:
Specific Aim 1. Evaluate the feasibility of monitoring sleep and circadian neuroendocrine rhythms in a high fidelity operational simulation of a 105-day expedition mission, in preparation for such monitoring in longer duration simulations that include the 24.65-hour Martian sol.
Specific Aim 2. Test the hypothesis that sleep, alertness, performance and mood will be impaired during acute circadian misalignment associated with night shift work operations in a high fidelity operational simulation of a 105-day expedition mission;
Specific Aim 3. Test the hypothesis that alertness, performance and mood of crewmembers exposed to shorter wavelength light (with a peak wavelength between 485 to 525 nm) during the night shift in the console monitoring room will be significantly better than the alertness, performance and mood of those same crewmembers when they are exposed to intermediate wavelength light (with a peak wavelength of either 545 nm to 555 nm) or longer wavelength light (620 nm to 690 nm) during the night shift. We hypothesize that these improvements in alertness, performance and mood will be associated with suppression of the pineal hormone melatonin. Melatonin levels are expected to be lowest across the night shift during exposure to the short 485 nm-525 nm light; low for the first quartile of the night shift during exposure to the intermediate wavelength 545 nm-555 nm light; and highest during exposure to the longer wavelength 620 nm-690 nm light. This aim will permit us to evaluate the feasibility of deploying lighting countermeasures (Light Tower; Sunnex Biotechnologies Winnipeg, Manitoba, Canada; ww.Sunnexbiotech.com) in the control panel room (inside the module EU-150) to assess the effects of this wavelength of light on alertness, performance, and subsequent sleep, in preparation for deploying lighting countermeasures in longer duration simulations that include the 24.65-hour Martian sol. Subjects will be randomized to the three lighting conditions using a balanced Latin square design.
Specific aim 4. Test the hypothesis that the alertness, performance and mood of the external mission controllers will be impaired during the final third of their extended duration, 24-hour work shifts as compared with the first third of that same work shift. We anticipate that the acute total sleep deprivation and circadian misalignment associated with hours 16 through 24 of their work shift will significantly degrade their alertness, performance and mood.
Specific aim 5. Test the hypothesis that the alertness, performance and mood of external mission controllers exposed to shorter wavelength light (with a peak wavelength between 485 to 525 nm) during the final third of their extended duration work shift will be significantly better than the alertness, performance and mood of those same crewmembers when they are exposed to intermediate wavelength light (with a peak wavelength of either 545 nm to 555 nm) or longer wavelength light (620 nm to 690 nm) during the final third of their extended duration work shift.
The purpose of the proposed studies is to address five specific hypotheses aimed at validating methods to collect data to monitor performance, sleep and circadian rhythms in an operational environment. We also plan to evaluate the efficacy of a photic countermeasure designed to improve alertness, performance, mood during acute circadian misalignment during the 105-day mission in which crewmembers will be required to be on duty in the console monitoring room during the night shift every sixth night. These five hypotheses are based on the results of our preliminary data which indicate that: (a) night shift workers who invert their normal sleep/wake schedule experience sleep loss, decreased alertness and performance; (b) individual working extended duration, 24-hour shifts experience sleep loss and impaired alertness, performance and mood, especially during a critical zone of vulnerability between the 16th and 24th hours of such extended duration work shifts; (c) shorter wavelength light acutely suppresses melatonin and increases alertness, performance and mood during night work; and (d) shorter wavelength visible light is more effective than intermediate or longer wavelength light at suppressing melatonin and increasing alertness, performance and mood during the night.
- Being tested
- Bright Light Box
- Keywords
- Sleep, Alertness, fatigue, performance, spaceflight, isolation, light, Sleep , alertness and performance during a simulated spaceflight mission
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright Light BoxDevice
Increased lighting used during night shifts to prevent sleepiness.
| Study group | Role | What they receive |
|---|---|---|
| Shorter Wavelength (green) | Other | Not described Receives: Device: Bright Light Box |
| Intermediate Wavelength (white w/ green filter) | Other | Not described Receives: Device: Bright Light Box |
| Longer Wavelength (red) | Other | Placebo Receives: Device: Bright Light Box |
What is being measured
The primary outcome is the main question the study is designed to answer.
performance on variety of cognitive tasks (e.g., psychomotor vigilance task, digit symbol substitution task)
Measured: During the 105-day isolation
sleep, measured with actigraphy
Measured: During the 105-day isolation
circadian phase
Measured: During the 105-day isolation
subjective alertness
Measured: During the 105-day isolation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2010 (estimated)
- Study startAug 2008
- Primary completionJun 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for SleepStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Institute of Biomedical Problems, University of Pennsylvania, National Space Biomedical Research Institute
- Responsible party
- Principal investigator, Charles Andrew Czeisler, MD, PhD, Brigham and Women's Hospital
- Investigators
- Charles A Czeisler, Ph.D., M.D., Principal investigator, Brigham and Women's Hospital, Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169233
- Sponsor's protocol ID
- 2008-P-001304
- Other IDs
- HFP00002
- Acronym
- Mars 105
- Status last verified
- Apr 2015
- First submitted
- 12 Jan 2010
- Last updated
- 30 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Akerstedt T. Sleepiness as a consequence of shift work. Sleep. 1988 Feb;11(1):17-34. doi: 10.1093/sleep/11.1.17.
PubMed 3283910Akerstedt T, Gillberg M. Subjective and objective sleepiness in the active individual. Int J Neurosci. 1990 May;52(1-2):29-37. doi: 10.3109/00207459008994241.
PubMed 2265922Ashkenazi IE, Reinberg AE, Motohashi Y. Interindividual differences in the flexibility of human temporal organization: pertinence to jet lag and shiftwork. Chronobiol Int. 1997 Mar;14(2):99-113. doi: 10.3109/07420529709001148.
PubMed 9095371Brown EN, Czeisler CA; New Collective Author. The statistical analysis of circadian phase and amplitude in constant-routine core-temperature data. J Biol Rhythms. 1992 Fall;7(3):177-202. doi: 10.1177/074873049200700301.
PubMed 1421473Budnick LD, Lerman SE, Baker TL, Jones H, Czeisler CA. Sleep and alertness in a 12-hour rotating shift work environment. J Occup Med. 1994 Dec;36(12):1295-300. doi: 10.1097/00043764-199412000-00010.
PubMed 7884570Cajochen C, Munch M, Kobialka S, Krauchi K, Steiner R, Oelhafen P, Orgul S, Wirz-Justice A. High sensitivity of human melatonin, alertness, thermoregulation, and heart rate to short wavelength light. J Clin Endocrinol Metab. 2005 Mar;90(3):1311-6. doi: 10.1210/jc.2004-0957. Epub 2004 Dec 7.
PubMed 15585546Czeisler CA, Dijk DJ. Use of bright light to treat maladaptation to night shift work and circadian rhythm sleep disorders. J Sleep Res. 1995 Dec;4(S2):70-73. doi: 10.1111/j.1365-2869.1995.tb00231.x.
PubMed 10607216Czeisler CA, Walsh JK, Roth T, Hughes RJ, Wright KP, Kingsbury L, Arora S, Schwartz JR, Niebler GE, Dinges DF; U.S. Modafinil in Shift Work Sleep Disorder Study Group. Modafinil for excessive sleepiness associated with shift-work sleep disorder. N Engl J Med. 2005 Aug 4;353(5):476-86. doi: 10.1056/NEJMoa041292.
PubMed 16079371Czeisler CA and Wright Jr. KP. Influence of light on circadian rhythmicity in humans. edited by Turek FW and Zee PC. New York: Marcel Dekker, Inc., 1999, p. 149-180.
Di Lorenzo L, De Pergola G, Zocchetti C, L'Abbate N, Basso A, Pannacciulli N, Cignarelli M, Giorgino R, Soleo L. Effect of shift work on body mass index: results of a study performed in 319 glucose-tolerant men working in a Southern Italian industry. Int J Obes Relat Metab Disord. 2003 Nov;27(11):1353-8. doi: 10.1038/sj.ijo.0802419.
PubMed 14574346Dubbelman M, Van der Heijde GL. The shape of the aging human lens: curvature, equivalent refractive index and the lens paradox. Vision Res. 2001 Jun;41(14):1867-77. doi: 10.1016/s0042-6989(01)00057-8.
PubMed 11369049el-Hajj Fuleihan G, Klerman EB, Brown EN, Choe Y, Brown EM, Czeisler CA; New Collective Author. The parathyroid hormone circadian rhythm is truly endogenous--a general clinical research center study. J Clin Endocrinol Metab. 1997 Jan;82(1):281-6. doi: 10.1210/jcem.82.1.3683.
PubMed 8989274Foster RG; New Collective Author. Neurobiology: bright blue times. Nature. 2005 Feb 17;433(7027):698-9. doi: 10.1038/433698a. No abstract available.
PubMed 15716938Gais S, Plihal W, Wagner U, Born J. Early sleep triggers memory for early visual discrimination skills. Nat Neurosci. 2000 Dec;3(12):1335-9. doi: 10.1038/81881.
PubMed 11100156Gold DR, Rogacz S, Bock N, Tosteson TD, Baum TM, Speizer FE, Czeisler CA; New Collective Author. Rotating shift work, sleep, and accidents related to sleepiness in hospital nurses. Am J Public Health. 1992 Jul;82(7):1011-4. doi: 10.2105/ajph.82.7.1011.
PubMed 1609900
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operational Evaluation of a Photic Countermeasure to Improve Alertness, Performance, and Mood During Nightshift Work on a 105-day Simulated Human Exploration Mission to Mars
- ClinicalTrials.gov ID
- NCT01169233
- Acronym / sponsor ID
- Mars 105 / 2008-P-001304
- Keywords
- Sleep, Alertness, fatigue, performance, spaceflight, isolation, light, Sleep , alertness and performance during a simulated spaceflight mission
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- The Institute of Biomedical Problems, University of Pennsylvania, National Space Biomedical Research Institute
- Study start
- Aug 2008
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 26 Jul 2010 (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 success of human expedition missions critically depend on the ability of the crew to be alert and maintain high levels of cognitive function while operating complex, technical equipment. Optimal human health, performance and safety during space flight requires sufficient sleep and synchrony between the circadian pacemaker-which regulates the timing of sleep, endocrine function, alertness and performance-and the timing of the imposed sleep-wake schedule.
Crewmembers of the 105-day simulation study will be required to work one night shift every sixth night. This schedule will likely result in sleep loss and circadian misalignment, especially when lighting conditions are similar to those that crewmembers experience during spaceflight. External mission controllers will work 24-hour shifts, also resulting in both sleep loss and circadian misalignment.
It has been well documented in laboratory and field studies that both working the night shift and working extended duration shifts result in decrement alertness, performance and mood. In addition to the negative effects that night shift work has on alertness, performance and mood, shift work causes significant short and long-term health problems. Shift workers, particularly night shift workers who invert their normal sleep/wake schedule, suffer for several reasons. First, their endogenous circadian rhythms and the imposed sleep/work schedule are typically out of phase. This is similar to the experience of jet lag. However, while environment cues (e.g., sunrise, sunset, the timing of meals and sleep) enable travelers to adapt quickly to a new time zone, crewmembers in the 105-day simulation will be unable to do so because they will only spend one night of every five working. When working the night shift, the timing of meals, work, and sleep will therefore be out of phase with the normal entrained phase of the circadian timing system. Ingestion of meals at an inappropriate circadian phase results in impaired metabolism, likely underlying the gastrointestinal and metabolic problems experienced by shift workers. Second, this circadian misalignment leads to a substantial loss of sleep efficiency during the (daytime) sleep period, independent of, and in addition to, environmental obstacles to sleep (e.g., noise, light, other crewmembers). Third, misalignment of circadian phase coupled with sleep loss will each result in deterioration of alertness and impairment of performance during the night. Since these adverse effects are particularly acute on the first night of work, the plan for crewmembers on the Mars 105 mission to work the midnight shift every sixth night will subject them repeatedly to the performance impairments associated with acute circadian misalignment and acute sleep deprivation.
Lighting Countermeasure. Our group at the Harvard Medical School has successfully developed and tested effective photic countermeasures to alleviate circadian misalignment and improve alertness, performance and mood in night shift workers. The most effective countermeasure to circadian alignment is appropriately-timed and sufficiently intense light. Light also acutely improves alertness, performance and mood. Most recently it has been reported that short wavelength light has been shown to be most effective for both resetting circadian rhythms and acutely improving performance during night work via antecedent suppression of the soporific hormone melatonin.
These photic countermeasures have been tested in individual subjects living in laboratory simulations (Countermeasures readiness level/Technology readiness level 7; Evaluation with human subjects in controlled laboratory simulating operational spaceflight environment). The next critical step is to evaluate our countermeasures in an operational simulation of space flight that includes study of the interaction among crew members in a high fidelity simulation (Countermeasures readiness level/Technology readiness level 8; Validation with human subjects in actual operational spaceflight to demonstrate efficacy and operational feasibility).
Adequate sleep and circadian alignment are critical to maintaining the health and performance of expedition mission crewmembers. Testing of the developed lighting countermeasure in a high fidelity operational environment imitating the conditions of a future expedition mission (e.g., to Mars) is critical to ensure countermeasure readiness and to reduce the risk of human performance errors due to factors related to circadian disruption, sleep loss and fatigue. Development and testing of this photic countermeasure for mission controllers working 24-hour shifts will further ensure the success of the future long duration expedition missions.
Detailed description
The objective and tasks of the investigation.
The purpose of this study is to validate the efficacy and operational feasibility of a photic countermeasure to improve alertness and performance during night shift work occurring during a simulated expedition mission. We propose to address the following specific aims:
Specific Aim 1. Evaluate the feasibility of monitoring sleep and circadian neuroendocrine rhythms in a high fidelity operational simulation of a 105-day expedition mission, in preparation for such monitoring in longer duration simulations that include the 24.65-hour Martian sol.
Specific Aim 2. Test the hypothesis that sleep, alertness, performance and mood will be impaired during acute circadian misalignment associated with night shift work operations in a high fidelity operational simulation of a 105-day expedition mission;
Specific Aim 3. Test the hypothesis that alertness, performance and mood of crewmembers exposed to shorter wavelength light (with a peak wavelength between 485 to 525 nm) during the night shift in the console monitoring room will be significantly better than the alertness, performance and mood of those same crewmembers when they are exposed to intermediate wavelength light (with a peak wavelength of either 545 nm to 555 nm) or longer wavelength light (620 nm to 690 nm) during the night shift. We hypothesize that these improvements in alertness, performance and mood will be associated with suppression of the pineal hormone melatonin. Melatonin levels are expected to be lowest across the night shift during exposure to the short 485 nm-525 nm light; low for the first quartile of the night shift during exposure to the intermediate wavelength 545 nm-555 nm light; and highest during exposure to the longer wavelength 620 nm-690 nm light. This aim will permit us to evaluate the feasibility of deploying lighting countermeasures (Light Tower; Sunnex Biotechnologies Winnipeg, Manitoba, Canada; ww.Sunnexbiotech.com) in the control panel room (inside the module EU-150) to assess the effects of this wavelength of light on alertness, performance, and subsequent sleep, in preparation for deploying lighting countermeasures in longer duration simulations that include the 24.65-hour Martian sol. Subjects will be randomized to the three lighting conditions using a balanced Latin square design.
Specific aim 4. Test the hypothesis that the alertness, performance and mood of the external mission controllers will be impaired during the final third of their extended duration, 24-hour work shifts as compared with the first third of that same work shift. We anticipate that the acute total sleep deprivation and circadian misalignment associated with hours 16 through 24 of their work shift will significantly degrade their alertness, performance and mood.
Specific aim 5. Test the hypothesis that the alertness, performance and mood of external mission controllers exposed to shorter wavelength light (with a peak wavelength between 485 to 525 nm) during the final third of their extended duration work shift will be significantly better than the alertness, performance and mood of those same crewmembers when they are exposed to intermediate wavelength light (with a peak wavelength of either 545 nm to 555 nm) or longer wavelength light (620 nm to 690 nm) during the final third of their extended duration work shift.
The purpose of the proposed studies is to address five specific hypotheses aimed at validating methods to collect data to monitor performance, sleep and circadian rhythms in an operational environment. We also plan to evaluate the efficacy of a photic countermeasure designed to improve alertness, performance, mood during acute circadian misalignment during the 105-day mission in which crewmembers will be required to be on duty in the console monitoring room during the night shift every sixth night. These five hypotheses are based on the results of our preliminary data which indicate that: (a) night shift workers who invert their normal sleep/wake schedule experience sleep loss, decreased alertness and performance; (b) individual working extended duration, 24-hour shifts experience sleep loss and impaired alertness, performance and mood, especially during a critical zone of vulnerability between the 16th and 24th hours of such extended duration work shifts; (c) shorter wavelength light acutely suppresses melatonin and increases alertness, performance and mood during night work; and (d) shorter wavelength visible light is more effective than intermediate or longer wavelength light at suppressing melatonin and increasing alertness, performance and mood during the night.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Shorter Wavelength (green) | Other | Device: Bright Light Box |
| Intermediate Wavelength (white w/ green filter) | Other | Device: Bright Light Box |
| Longer Wavelength (red) | Other | Device: Bright Light BoxPlacebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Any individual chosen by the Institute of Biomedical Problems to participate in or support the space flight simulation study was eligible to participate in the study.
Key exclusion criteria (1 listed)
- None. Any individual chosen by the Institute of Biomedical Problems to participate in or support the space flight simulation study was eligible to participate in the study.
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 |
|---|---|---|
| Bright Light BoxIncreased lighting used during night shifts to prevent sleepiness. | Device | Intermediate Wavelength (white w/ green filter), Longer Wavelength (red), Shorter Wavelength (green) |
Primary outcome
performance on variety of cognitive tasks (e.g., psychomotor vigilance task, digit symbol substitution task)
Time frame: During the 105-day isolation
sleep, measured with actigraphy
Time frame: During the 105-day isolation
circadian phase
Time frame: During the 105-day isolation
subjective alertness
Time frame: During the 105-day isolation
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 Apr 2015.
- Background: PubMed 3283910Akerstedt T. Sleepiness as a consequence of shift work. Sleep. 1988 Feb;11(1):17-34. doi: 10.1093/sleep/11.1.17.
- Background: PubMed 2265922Akerstedt T, Gillberg M. Subjective and objective sleepiness in the active individual. Int J Neurosci. 1990 May;52(1-2):29-37. doi: 10.3109/00207459008994241.
- Background: PubMed 9095371Ashkenazi IE, Reinberg AE, Motohashi Y. Interindividual differences in the flexibility of human temporal organization: pertinence to jet lag and shiftwork. Chronobiol Int. 1997 Mar;14(2):99-113. doi: 10.3109/07420529709001148.
- Background: PubMed 1421473Brown EN, Czeisler CA; New Collective Author. The statistical analysis of circadian phase and amplitude in constant-routine core-temperature data. J Biol Rhythms. 1992 Fall;7(3):177-202. doi: 10.1177/074873049200700301.
- Background: PubMed 7884570Budnick LD, Lerman SE, Baker TL, Jones H, Czeisler CA. Sleep and alertness in a 12-hour rotating shift work environment. J Occup Med. 1994 Dec;36(12):1295-300. doi: 10.1097/00043764-199412000-00010.
- Background: PubMed 15585546Cajochen C, Munch M, Kobialka S, Krauchi K, Steiner R, Oelhafen P, Orgul S, Wirz-Justice A. High sensitivity of human melatonin, alertness, thermoregulation, and heart rate to short wavelength light. J Clin Endocrinol Metab. 2005 Mar;90(3):1311-6. doi: 10.1210/jc.2004-0957. Epub 2004 Dec 7.
- Background: PubMed 10607216Czeisler CA, Dijk DJ. Use of bright light to treat maladaptation to night shift work and circadian rhythm sleep disorders. J Sleep Res. 1995 Dec;4(S2):70-73. doi: 10.1111/j.1365-2869.1995.tb00231.x.
- Background: PubMed 16079371Czeisler CA, Walsh JK, Roth T, Hughes RJ, Wright KP, Kingsbury L, Arora S, Schwartz JR, Niebler GE, Dinges DF; U.S. Modafinil in Shift Work Sleep Disorder Study Group. Modafinil for excessive sleepiness associated with shift-work sleep disorder. N Engl J Med. 2005 Aug 4;353(5):476-86. doi: 10.1056/NEJMoa041292.
- BackgroundCzeisler CA and Wright Jr. KP. Influence of light on circadian rhythmicity in humans. edited by Turek FW and Zee PC. New York: Marcel Dekker, Inc., 1999, p. 149-180.
- Background: PubMed 14574346Di Lorenzo L, De Pergola G, Zocchetti C, L'Abbate N, Basso A, Pannacciulli N, Cignarelli M, Giorgino R, Soleo L. Effect of shift work on body mass index: results of a study performed in 319 glucose-tolerant men working in a Southern Italian industry. Int J Obes Relat Metab Disord. 2003 Nov;27(11):1353-8. doi: 10.1038/sj.ijo.0802419.
- Background: PubMed 11369049Dubbelman M, Van der Heijde GL. The shape of the aging human lens: curvature, equivalent refractive index and the lens paradox. Vision Res. 2001 Jun;41(14):1867-77. doi: 10.1016/s0042-6989(01)00057-8.
- Background: PubMed 8989274el-Hajj Fuleihan G, Klerman EB, Brown EN, Choe Y, Brown EM, Czeisler CA; New Collective Author. The parathyroid hormone circadian rhythm is truly endogenous--a general clinical research center study. J Clin Endocrinol Metab. 1997 Jan;82(1):281-6. doi: 10.1210/jcem.82.1.3683.
- National Space Biomedical Research InstituteLink provided by the sponsor.
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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, Ph.D., M.D. principal investigator
Brigham and Women's Hospital, Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright Light Box in people with Sleep and Alertness, run by Brigham and Women's Hospital at 1 site in Russia.
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 1 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 Apr 2015. 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 Russia. 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?
performance on variety of cognitive tasks (e.g., psychomotor vigilance task, digit symbol substitution task) (time frame: During the 105-day isolation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01169233, which also lists 37 linked publications.
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 Apr 2015.