Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Light application
Patent
1992-01-10
1994-04-19
Smith, Ruth S.
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Light application
A61N 506
Patent
active
053042123
DESCRIPTION:
DESCRIPTION
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
A first method is directed to the accurate assessment of the phase and amplitude resetting capacity of the endogenous circadian pacemaker for a particular subject within a relatively short time frame. A second method is directed to the actual modification of the phase and/or amplitude of that pacemaker using scheduled periods of bright light, advantageously enhanced with manipulation of dark (rest) periods, based on either normative phase assessments or on a phase assessment of that individual subject. Phase and amplitude modification may be achieved based on either empirically derived normative data or based on a mathematical model, relating to the existing state of the deep circadian pacemaker. Finally, devices which facilitate the practice of the assessment and modification methods are described.
1. Foundations for the Inventive Techniques of Assessing Circadian Phase
and Amplitude Resetting Capacity
As stated above in the Background of the Invention, there have been a variety of lengthy techniques used to try to assess the phase resetting capacity of the circadian timing system, none of which was ideally suitable for use in humans. The most commonly used technique used in animal studies, delivery of a stimulus during a synchronized free-run, is an inadequate means of testing the response capacity of the human circadian system to a signal. This is because after disturbance of the sleep-wake cycle the body temperature cycle would no longer oscillate at the compromise period it displays during a synchronized free run (T.sub.S) which is usually longer than its intrinsic period (T.sub.X), but would instead oscillate for 1-2 cycles at its intrinsic period. This would make most signals appear to cause a modest phase advance, as occurs in response to one night of sleep deprivation (see C. A. Czeisler et al., "Sleep Deprivation in Constant Light Phase Advance Shifts and Shortens the Free-Running Period of the Human Circadian Timing System," Sleep Research, Volume 14, p. 252. See also Honma, K., Honma, S., Wada, T., "Phase Dependent Responses of Human Circadian Rhythms to a Bright Pulse: Experiments in a Temporal Isolation Unit", J. Physol. Soc. Jap., Vol. 48, p. 416 (1986).). In addition, the free-running rest-activity cycle is not an accurate marker of the endogenous circadian phase in human subjects.
Thus, we designed a technique to combine a method to rapidly assess the phase and amplitude of the endogenous circadian pacemaker before and after delivery of a stimulus protocol. With the stimulus protocol itself.
Presently, the most widely recognized method to assess the phase and amplitude of the endogenous circadian oscillator is to track the body temperature cycle during long-term studies where behavioral activity is desynchronized from the output of the endogenous oscillator, thereby distributing masking effects of activity on the temperature cycle across a variety of temperature phases. Typically, this assessment method is carried out prior to, and following a particular intervention in order to assess the effect of that intervention on the circadian oscillator. However, since masking effects are not in any way eliminated, each of the assessments require the collection of 4-6 weeks of continuously recorded data in a time-isolated facility. Following spectral analysis of the data, an endogenous circadian period is determined. Using this period, an average waveform is educed. Endogenous circadian phase and amplitude are determined from this educed waveform. For statistical reasons, this estimate is most accurate only for days in the middle of the study, and achieves its greatest inaccuracies at the beginning and end of the study. Also, because this method is dependent upon an accurate period assessment, a misestimation of period, when iterated over the length of the study, can result a several hour misestimation of phase at the beginning or end of the study.
Because this method is inaccurate in initial and final phase estimation, it is unsuited to be used
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Allan James S.
Czeisler Charles A.
Kronauer Richard E.
Brigham and Women's Hospital
Smith Ruth S.
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