US2004020496A1PendingUtilityA1

Non-ocular circadian clock resetting in humans

Priority: May 12, 1997Filed: May 12, 2003Published: Feb 5, 2004
Est. expiryMay 12, 2017(expired)· nominal 20-yr term from priority
A61N 5/0618A61N 2005/0652
37
PatentIndex Score
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Cited by
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Claims

Abstract

A method for resetting the phase of the human circadian clock and for enhancing alertness and performance in humans is disclosed. The method involves the application of non-solar photic stimulation, in the range of 15 to 150,000 lux, to any non-ocular region of the human body during wakefulness or during sleep. Preferably, the photic stimulation has a wavelength within the visible spectrum (˜400-750 nm). The method can be used to both delay and advance the circadian clock according to a phase response curve (PRC). The method may also be used for acute/immediate enhancement of alertness and performance. The method is applicable to alleviation of problems associated with “jet-lag”, shift work sleep disturbance, and other sleep disturbances involving misalignment of circadian rhythms. The method provides a novel technique for shifting the phase of the circadian clock, and enhancing alertness and performance, using existing, or newly-developed devices.

Claims

exact text as granted — not AI-modified
What is claimed is:  
     
         1 . A method of resetting a human circadian clock comprising the step of exposing a non-ocular region of a human subject to a non-solar photic stimulation during one or more circadian cycles to reset the human circadian clock.  
     
     
         2 . The method according to  claim 1  further comprising the step of assessing a time when a daily minimum body temperature for the human subject occurs, wherein said step of exposing the non-ocular region begins at an exposure time dependent upon the assessed time.  
     
     
         3 . The method according to  claim 2  wherein said step of exposing the non-ocular region begins before the assessed time.  
     
     
         4 . The method according to  claim 3  wherein said step of exposing the non-ocular region begins within about six hours prior to the assessed time.  
     
     
         5 . The method according to  claim 2  wherein said step of exposing the non-ocular region begins after the assessed time.  
     
     
         6 . The method according to  claim 5  wherein said step of exposing the non-ocular region begins within six hours after the assessed time.  
     
     
         7 . The method according to  claim 1  wherein said step of exposing the non-ocular region occurs while the human subject is awake.  
     
     
         8 . The method according to  claim 1  wherein said step of exposing the non-ocular region occurs while the human subject is asleep.  
     
     
         9 . The method according to  claim 1  wherein said step of exposing the non-ocular region lasts for a duration ranging from between about 15 minutes to about 12 hours.  
     
     
         10 . The method according to  claim 9  wherein the duration of said non-ocular exposure is about three hours.  
     
     
         11 . The method according to  claim 1  wherein said non-solar photic stimulation has an intensity between about 15 lux to about 150,000 lux.  
     
     
         12 . The method according to  claim 11  wherein said non-solar photic stimulation has an intensity between about 10,000 lux to about 13,000 lux.  
     
     
         13 . The method according to  claim 1  wherein said non-solar photic stimulation has a bandwidth in the visible spectrum.  
     
     
         14 . The method according to  claim 13  wherein said non-solar photic stimulation has a bandwidth between about 455 nanometers (nm) and 540 nm.  
     
     
         15 . The method according to  claim 1  wherein the given number of circadian cycles is one.  
     
     
         16 . The method according to  claim 1  wherein the given number of circadian cycles is two or more.  
     
     
         17 . The method according to  claim 1  wherein the non-ocular region of the human subject has ample surface vasculature.  
     
     
         18 . The method according to  claim 19  wherein the non-ocular region is a popliteal region of the human subject.  
     
     
         19 . The method according to  claim 1  wherein said step of exposing the non-ocular region is used to treat a circadian rhythm sleep disorder.  
     
     
         20 . The method according to  claim 19  wherein said step of exposing the non-ocular region is used to treat the circadian rhythm sleep disorder resulting from transmeridian travel (jet-lag).  
     
     
         21 . The method according to  claim 19  wherein said step of exposing the non-ocular region is used to treat Shift Work Sleep Disorder.  
     
     
         22 . The method according to  claim 19  wherein said step of exposing the non-ocular region is used to treat Advanced Sleep Phase Syndrome (ASPS).  
     
     
         23 . The method according to  claim 19  wherein said step of exposing the non-ocular region is used to treat Delayed Sleep Phase Syndrome (DSPS).  
     
     
         24 . The method according to  claim 19  wherein said step of exposing the non-ocular region is used to treat Non-24-Hour Sleep-Wake Disorder.  
     
     
         25 . The method according to  claim 19  wherein said step of exposing the non-ocular region is used to treat Irregular Sleep-Wake Pattern.  
     
     
         26 . The method according to  claim 1  wherein said step of exposing the non-ocular region is used to treat sleep and circadian rhythm disorders associated with blindness.  
     
     
         27 . The method according to  claim 1  wherein said step of exposing the non-ocular region is used to treat sleep and circadian rhythm disorders in individuals for whom ocular light exposure is contraindicated.  
     
     
         28 . A method of enhancing nighttime alertness and performance in a human subject comprising the step of exposing a substantially non-ocular region of the human subject to a non-solar photic stimulation during one or more circadian cycles.  
     
     
         29 . The method according to  claim 28  wherein said step of exposing the non-ocular region is used to enhance alertness and performance of workers on rotating shift work schedules.  
     
     
         30 . The method according to  claim 28  wherein said step of exposing the non-ocular region is used to enhance alertness and performance of individuals working permanent work schedules.  
     
     
         31 . The method according to  claim 28  wherein said step of exposing the non-ocular region lasts for a duration ranging from between about 15 minutes to about 12 hours.  
     
     
         32 . The method according to  claim 28  wherein said non-solar photic stimulation has an intensity between about 15 lux to about 150,000 lux.  
     
     
         33 . The method according to  claim 28  wherein said non-solar photic stimulation has a bandwidth in the visible spectrum.  
     
     
         34 . The method according to  claim 28  wherein the non-ocular region of the human subject has ample surface vaculature.  
     
     
         35 . The method according to  claim 28  wherein the non-ocular region is a popliteal region of the human subject.  
     
     
         36 . A method of resetting a human circadian clock comprising the steps of: 
 assessing a time when a minimum body temperature for a human subject; and    exposing a substantially non-ocular region of the human subject to a non-solar photic stimulation for one or more circadian cycles to reset the human circadian clock at an exposure time dependent upon the assessed time.    
     
     
         37 . The method according to  claim 36  wherein said step of exposing the non-ocular region begins before the assessed time.  
     
     
         38 . The method according to  claim 36  wherein said step of exposing the non-ocular region begins about six hours prior to the assessed time.  
     
     
         39 . The method according to  claim 36  wherein said step of exposing the non-ocular region begins after the assessed time.  
     
     
         40 . The method according to  claim 39  wherein said step of exposing the non-ocular region begins within six hours after the assessed time.  
     
     
         41 . The method according to  claim 36  wherein said step of exposing the non-ocular region occurs while the human subject is awake.  
     
     
         42 . The method according to  claim 36  wherein said step of exposing the non-ocular region occurs while the human subject is asleep.  
     
     
         43 . The method according to  claim 36  wherein said step of exposing the non-ocular region lasts for a duration ranging from between about 15 minutes to about 12 hours.  
     
     
         44 . The method according to  claim 43  wherein the duration of said non-ocular exposure is about three hours.  
     
     
         45 . The method according to  claim 36  wherein said non-solar photic stimulation has an intensity between about 15 lux to about 150,000 lux.  
     
     
         46 . The method according to  claim 45  wherein said non-solar photic stimulation has an intensity between about 10,000 lux to about 13,000 lux.  
     
     
         47 . The method according to  claim 36  wherein said non-solar photic stimulation has a bandwidth in the visible spectrum.  
     
     
         48 . The method according to  claim 47  wherein said non-solar photic stimulation has a bandwidth between about 455 nm and 540 nm .  
     
     
         49 . The method according to  claim 36  wherein the number of circadian cycles is one.  
     
     
         50 . The method according to  claim 36  wherein the number of circadian cycles is two or more.  
     
     
         51 . The method according to  claim 36  wherein the non-ocular region of the human subject has ample surface vasculature.  
     
     
         52 . The method according to  claim 51  wherein the non-ocular region is a popliteal region of the human subject.

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