The invention relates to the field of methods for determining the dichotomy index of an individual, i.e. the index identifying the regularity of the alternation of day activity and night rest as well as their amplitude over 24H giving the possibility of providing a measurement of the circadian rhythm.
Disruptions of the circadian system which may be caused by working in shifts significantly increase the risk of cancer, notably breast, colon and prostate cancer. Also, perturbation of the activity—rest circadian rhythms, measured by actimetry, represents a negative prognostic factor in terms of survival in patients affected with metastatic colon, breast, kidney, ovary or lung cancer, independently of known prognostic factors.
Actimetry consists in a non-invasive technique for measuring the activity/rest cycle and of the sleep-wake rhythm: the circadian rhythm. To do this, an actimeter is used, appearing as a casing provided with at least one accelerometer and which records the successive zero-crossings of the acceleration.
This type of device coupled with a server allowing analysis of the collected data gives the possibility of reliably estimating periods of activity and of sleep, well correlated with those detected by polysomnography, with however greater uncertainty for falling asleep than for awaking.
Although the actimeter is considered as the “gold standard” for measuring activity/rest, it is not ideal for individuals admitted to hospital with a severe pathology and/or which have very reduced mobility, and therefore low physical activity. This is notably due to the fact that the activity levels are considerably lower than those of healthy individuals which makes it extremely difficult to make a distinction between the rest phase and the wakefulness phase, in particular for falling asleep.
The usual methods for detecting activity in this type of individual, adapt the detection thresholds by using parametric or non-parametric algorithms based on smoothing, logical combinations or approaches based on artificial neurone networks as disclosed in Tilmanne, J. “algorithms for sleep-wake identification using actigraphy: a comparative study and new results” Journal of Sleep Research 2009, 18, (1) pp 85-98.
In particular, these are neural networks which give the best result. However, in spite of these algorithmic progress, a percentage of errors persists at the detection of the breach between rest and awareness for hospitalized individuals.
The present invention therefore has the purpose of proposing a method for automatically determining the dichotomy index I<O of an individual, giving the possibility of at least overcoming a portion of the drawbacks of the prior art, by proposing a means for automatically and specifically detecting the activity and rest states on the basis of the dichotomy index which may be applied to all individuals, including persons having very low activity such as elderly persons, or hospitalized persons without using the thresholding methods applied by the prior algorithms.
For this purpose, the invention relates to a method for automatically determining the dichotomy index I<O of an individual, from at least data from a system comprising:
with:
The dichotomy index I<O, represents the percentage of activity, per minute during the rest period (usually at night), which is less than the median of activity away from the bed (usually during daytime). It is a reliable indicator of the activity-rest circadian rhythm. It is calculated from the measurement of the number of accelerations per minute and from the position of the patient by means of a thorax actimeter worn for at least three consecutive days. This is a non-invasive measurement, generally well accepted by the patients.
“ZCM” or the Zero Crossing Mode corresponds to the number of times that the signal passes through 0 for each time period.
“positionX” corresponds to the value of the angle formed by the accelerometer relatively to the ascending vertical when the latter is worn on the chest of the individual.
According to a particularity, the data signals comprise values taken at a regular interval over a time period of 24 hours.
According to another particularity, when the number of values of the data signals for the temperature sensor and the accelerometer are different, the processor carries out a normalization step on the data recorded in the memory prior to step B, by using a cubic spline polynomial interpolation so that each value from the temperature signal is assigned to a value of the positionX and ZCM signals, and said values are recorded in the memory of the system.
According to another particularity, during step B, the processor suppresses from the memory all the values of temperature data strictly less than 30° C. and the values of the positionX and ZCM signals which are associated in time with the temperature value strictly less than 30° C.
According to another particularity, during step C, the processor independently applies on the whole of the positionX and ZCM data the following sub-steps:
According to another particularity, the blocks of values are constituted by 31 values corresponding to a time period of 31 minutes of the signals, the median is calculated over the first 10 data of the unique data set and the reset to zero is accomplished by sub-sets of 5 data corresponding to 5 consecutive minutes, if there are less than 2 values greater than the median, then the processor resets to zero in the memory the corresponding sub-set.
According to another particularity, during step D, on the whole of the positionX signal, the processor
According to another particularity, during step E, on the whole of the ZCM signal, the processor:
According to another particularity, during step F, the processor carries out a comparison of the ZCM_binary and positionX_binary data signals in order to determine the time indexes of the plateau for which the initial and final data values correspond to 1, the lying-down state.
According to another particularity, during step G, the processor does not take into account for calculating the dichotomy index, the data corresponding to a time period of one hour before and of one hour after the beginning of the plateau and one hour before and one hour after the end of the plateau.
Other features, details and advantages of the invention will become apparent upon reading the description which follows with reference to the appended figures:
A non-limiting example of an embodiment of the method for automatically determining the dichotomy index I<O of an individual according to the invention is now described. It uses data from a portable module composed of at least:
As an example, the accelerometer used may be the “ADXL345” accelerometer capable of generating a readout of the activity (or “ZCM” Zero Crossing Mode ZCM (zero crossing mode) which corresponds to the number of times during which the signal crosses 0 for each time period) and of the tilt (or “positionX”) every minute. The temperature sensor is preferably a sensor of the infrared type configured for measuring the body temperature every 5 minutes.
The portable module may be connected through a wireless communication circuit with a collector module for example through a Bluetooth, WIFI, or GPRS connection. Said collector module communicates the signals to the server. This communication may be GPRS, Bluetooth, WIFI, LIFI, infrared, radio or wired by means of a communication circuit of a computing resources, for example a server including a processing unit, for example a processor, a memory and a program using the data temporarily stored in the memory of the module and issued to the memory of the server through the communication circuit.
In some embodiment, the portable module does not require to be connected to the server. Indeed, the portable module can include the computing resources as a processing unit, for example a processor, a memory and a program using the data from the sensor and accelerometer, temporarily stored in the memory of the module, to perform the method for automatically determining the dichotomy index I<O of an individual. In other words, the portable module and the function of the server can be reunited in one portable element.
Thus, every 24 hours, the server receives the measurements corresponding to 3 data signals, a first signal corresponding to a succession of representative values of the body temperature of the individual for example taken every 5 minutes over a 24-hour period, (a higher frequency may of course be used but is not necessarily relevant given that the variation of the body temperature is slow), a second “ZCM” signal corresponding to a succession of values representative of the activity of the individual for example taken every minute over a period of 24 hours and a third “positionX” signal (
A “24-hours period” is understood to mean: a period of 24 hours which can include a corrective factor (which can be added to, or subtracted from, this time period) of the order of a few minutes to a maximum of the order of one hour. This correction factor may for example be calculated on the basis of previous measurements for an individual, in order to determine the duration of these cycles, for example over one or more past cycles. This factor can also be determined on the basis of statistical estimates of the duration of future cycles of the individual, for example on the basis of past measures and/or various predictive factors.
In order to obtain as many temperature values as there are “positionX” or “ZCM” values, the server carries out a normalization step on the temperature data recorded within the memory, by using a cubic spline polynomial interpolation so that every temperature readout gives 5 values in order to obtain a temperature value for each “positionX” and “ZCM” value versus time.
Subsequently, a step for suppressing the data generated by the portable module when it is not worn is carried out by the server. For this purpose, the server includes a program allowing during its execution, identification of the temperature values of less than 30° C. as well as their time index, i.e. the time reference for the taking of the measurement. This algorithm suppresses from the memory the temperature values of less than 30° C. as well as the “ZCM” and “positionX” values having the same time index (
A step for correcting the values from the “positionX” tilt signal may be carried out in order to not be found with negative angular values when the portable module is worn upside down. For this, when the “positionX” value is greater than 90° than the program executed by the server carries out the following transformation by subtracting from 180 the “positionX” value: 180−“positionX” value.
Subsequently, the server carries out an identification and zero reset step by the processor of the aberrant data from the “ZCM” and “positionX” signals. To do this, the processor independently carries out the following sub-steps on the whole of the “positionX” and “ZCM” data:
Following the step for removing the aberrant values “ZCM” and “positionX”, the server transforms the values of the “positionX” and “ZCM” signals into binary values 0 or 1. The binary value 1 corresponds to a rest state and the binary value 0 to a state of activity.
In order to do this, on the whole of the positionX signal, the processor:
For the transformation into binary values of the “ZCM” values, the processor over the whole of the “ZCM” signal, carries out the following operations:
For example:
ZCM_time[0]=CalculationVariance(ZCM_time [0], ZCM_time[1], . . . ,ZCM_time [9])
ZCM_time[1]=CalculationVariance(ZCM_time [1], ZCM_time[2], . . . ,ZCM_time [10])
ZCM_time[2]=CalculationVariance(ZCM_time [2], ZCM_time[3], . . . ,ZCM_time [11])
For example:
RMS[0]=Calculation_RMS(ZCM_time[0], ZCM_time[1])
RMS[1]=Calculation_RMS(ZCM_time[1], ZCM_time[2])+RMS[0]
RMS[2]=Calculation_RMS(ZCM_time[2], ZCM_time[3])+RMS[1]
Also the processor, on the whole of the “ZCM” signal, carries out the following operations:
Following these binary transformation steps, the server compares the binary values of the “ZCM” and “positionX” signals and identifies at least one rest state of the individual, represented by a set of at least 180 binary values equals to 1.
Finally the server calculates the dichotomy index and proceeds with its display on the display means such as a screen, by applying the following equation:
with:
To do this, the server, by executing the program on its processor, carries out the following sub-steps:
In order to improve accuracy, in a preferred embodiment, the processor does not take into account for calculating the dichotomy index, the data corresponding to a time period corresponding to one hour before and one hour after the beginning of the plateau and one hour before and one hour after the end of the plateau. In other words, ZCM_C corresponds to the set of the ZCM values for which the points are contained in the plateau except for the first and last hour of the plateau, and ZCM_L corresponds to the set of ZCM values for which the points are on either side of the plateau except for one hour before the plateau and one hour just after the plateau.
Thus, in this particular embodiment, for calculating the dichotomy index, the latter is only calculated over a period of 20 hours per slice of 24 hours (
According to another embodiment, if this is required in order to calculate the medians, a set of 16 values identical with the last value of the “ZCM” or “positionX” signal may be added at the end of the signals in order to obtain a sufficient number of values for carrying out the calculation of the medians.
Moreover, when the dichotomy index is greater than 97%, this means that the individual is well asleep and that his/her circadian rhythm is not perturbed.
This result represents a poor prognostic factor in terms of survival in hospitalized individuals, in particular for cancers notably when the dichotomy index is less than 97%.
Obtaining this result gives the possibility of knowing the circadian rhythm of an individual affected with cancer, which allows optimization of the time-modulated administration of the anticancer drugs thereby allowing improvement in tolerance and of the efficiency of the relevant anticancer drugs.
Such a method according to the invention gives the possibility of giving support to a physician with view to elaborating an optimum time-therapeutic scheme for each individual.
In addition, all the variables described above can all be dynamic variables (for example like the 24 hours period described above), which are defined on the basis of measured data and/or statistical estimates. Therefore, a a corrective factor can be added to or subtracted from them. Such corrective factor allows to take the individual variations between the patients into account for a given variable, for example as described herein.
The description of the present invention and the figures related thereto are not provided for limiting the scope of the invention but simply illustrate selected embodiments. One skilled in the art will understand that the technical features of a given embodiment according to a particularity, may in fact be combined with features of another embodiment according to another particularity unless the opposite is explicitly mentioned or if it is obvious that these features are incompatible. Further, the technical features described in a given embodiment according to a particularity, may be isolated from the other features of this embodiment unless the opposite is explicitly mentioned.
It should be obvious for those skilled in the art that the present invention allows embodiments under many other specific forms without departing from the field defined by the scope of the appended claims. They should be considered as an illustration and the invention should not be limited to the details given above.
Number | Date | Country | Kind |
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1562557 | Dec 2015 | FR | national |
Filing Document | Filing Date | Country | Kind |
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PCT/EP2016/081576 | 12/16/2016 | WO | 00 |