DE4230084A1 - System for monitoring sleeping-waking pattern and diagnosing sleep problems - has recording unit, memory, data transfer interface, evaluation program and activation control - Google Patents

Abstract

The system consists of a recording unit with a memory and an interface for data transfer and a special program for evaluation of the data stored in the recording unit. The following are some of the parameters which can be recorded: time to fall asleep, duration of sleep, time lying down, time between waking and arising, degree of sleep continuity and times of going to bed and arising. The recording unit can operate for 24 hours and starts to record after a single knob is operated. It is a small, portable device with user-adjustable signal tone sound vol. and frequency. The recorded data can be passed to a standard PC via an interface. USE/ADVANTAGE - For monitoring sleeping patterns and diagnosing problems. The system enables easier monitoring and objective evaluation.

Description

The invention relates to a system for monitoring sleep-wake behavior and for the diagnosis of sleep disorders according to claim 1.

• 1. Sleep is the most important recovery phase in our lives. Usually we try to judge the quality from a subjective point of view. This is extremely difficult and fraught with many problems and gives the doctor Often not a real picture for a proper treatment.
• 2. Sleep disorders are widespread, disease-possessing conditions (Appendix 1 and 2). In Germany, about 15% of adults have chronic insomnia (Insomnia). About 5% of adults have sleep apnea. About half of the cases of chronic insomnia are caused by chronic distress.
• 3. Chronic sleep disturbances due to a strong suffering pressure affect in the long run
  • - Performance
  • - psychological well-being
  • - physical condition
  • - social relationships
  • - Driving
  • - general health
• They are risk factors for
  • - Neuroses
  • - Depressions
  • - psychosomatic diseases
• 4. for the complex diagnosis of sleep disorders is currently only one objective complex method, the very elaborate electrophysiological Sleeppolygraphy, which is usually applied to sleep laboratories in Sleep medical centers is bound (data accumulation 70 MByte / patient / night diagnostic proportion in sleep disorders 0.1%) Available.
• In special clinics (eg neurology / psychiatry) find psychodiagnostic methods use to insomnia (insomnia) too  diagnose. But they only allow the collection of subjective Dates. In the last decade sleep protocols are increasingly being used. Actographers alone only register a restless sleep. The Established doctor is only to use the medical history as a diagnostic method Education and diagnosis of sleep disorders dependent. Out Lack of time but this diagnosis often consists only of the uncontrollable statement of the patient, which the doctor believes. On this Basis are the drug regulations. The dubious value Such statements have been the subject of investigations. The results are from the annexes (Annexes 3 and 4).
• 5. If you consider that 40-50% of patients who have a general Consult a general practitioner for sleep disorders (Fischer 1967; Frey and Gensch 1989), this is the largest area in this field Responsible for the diagnosis and therapy of Sleep disorders. Investigations reveal this critical situation and show that the regulation of drugs in reverse ratio on the quality of the diagnosis, d. H. most sleep and Tranquilizers are used by general practitioners and general practitioners prescribed, which has completely inadequate diagnostic tools (Annex 5).
• As a result, these physicians capture only one-third of the sleep-disordered pa the age group 18-65 years and half of the age group over 65 years (studies 1989 in Mannheim). The general practitioners have doctors absolutely no methods to differential diagnostic or therapeutic to be able to act.
• 6. Except the highly specialized sleep medical clinics and Centers can therefore assess the current situation in diagnostics and Therapy of sleep disorders does not correspond to the basic medical principle "You must have a confirmed diagnosis before initiating therapy". For all other diseases involving diagnostic procedures with biological (objective) assessment are the yardstick of all things An analogous procedure would not be acceptable as in sleep disorders. For example, no doctor would give a patient without prior objective Findings cure if this claims he is suffering from one Heart attack.  
• 7. With a unique history as a diagnostic basis for Verification of sleep disorders is also the requirement of do not realize international sleep medical diagnostic manual, after the "chronic sleep disorders then exist, if at least decreased three times a week for at least one month Sleep quality is present, the permanent impairment of the Performance, well-being and quality of life ".
• 8. The currently commercially available benzodiazepines as sleep aids are a controversial issue. For doctors, the 4-k rule is recommended:
  • - clear indication
  • - small dose
  • - shortest treatment time
  • - never abrupt discontinuation.
• For a clear indication is missing the practical or established doctor for diagnosis and differential diagnosis of sleep disorders the methodical Instrumentrarium. Most benzodiazepines may be (occasionally or only briefly) turns) act as a sleepwalker. They are not suitable for long-term use. Maximum duration of Application: less than 3 months. Thereafter, breaks of several months.
• 9. Side effects of sleeping pills (benzodiazepines) with prolonged use (3 months)
  • - Dependence, addiction
  • - no physiological sleep
  • - more or less strong influence on REM sleep
  • - Kidney damage
  • - liver damage
  • - change in the cardiovascular system (blood pressure)
  • - neuroticism
  • - Therapy resistance
  • - Disruption of the rhythm hierarchy of the organism
  • - Starting difficulties in the morning / loss of power during the day
  • - Therapy resistance
  • - Risk factors for depression and neurosis.
• It is now estimated that due to the lack of basic diagnostics for the practicing physician and the uncritical prescription of medicines without any scientific basis, sleep medicine is in deep crisis. The physician-patient ratio is significantly disturbed in terms of sleep disorders. For the realization of a scientifically based drug prescription for sleep disorders, therefore, a meaningful objective functional diagnostics, which is also applicable in general medical practice as well as in district hospitals, is an absolute requirement. We developed a concept for the development of a diagnostic step program for the objective assessment of sleep quality in relation to performance and stress during the day. The diagnostic step program is designed so that the interrelation between wakefulness and sleep is the focus of attention. The developed concept provides
  • - the simplest possible handling of the method,
  • - to pay attention to the fact that man is a biopsychosocial unit,
  • - a low load capacity of the patients by the method and applications under domestic conditions,
  • - Biorhythmometric analysis of the data obtained and corresponding chrono-biological interpretation
  • - development of appropriate microelectronic medical technology,
  • - a mathematical definition of sleep periods,
  • - Low cost of the equipment and for the use of this method.
• The sleep-wake monitoring system for diagnosing Sleep Disorders represents a basic level of this diagnostic And can be used both in the primary care of patients, as well as being applied in special areas, such as the list of Applications shows.

applications

• 1. For health control (control of sleep quality) over weeks, Months and years (unlimited time)
• 2. To control the relationship between sleep and wakefulness in relation to the time and the time of day (circadian rhythm)
• 3. To control the rhythmic way of life in relation to sleep-wakefulness cycle
• 4. For the diagnosis of sleep disorders in general medical practices, in clinics and hospitals.
  • 4.1. Use as single device possible
  • 4.2. Use in device systems, combined with other parameters (blood pressure, actogram, ECG, oxygen saturation, etc.) possible
  • 4.3. Use in combination with an actograph possible
• 5. Control of the course of therapy in sleep disorders
• 6. Verification of the effects of sleeping pills and sleep regulators
•  7. Control of sleep under human ecological aspects (ia. Traffic noise, chronic environmental influences, social isolation, tourism etc.)
•  8. Control of the sleep of pilots and train drivers with irregular sleep times
•  9. Control of sleep among shift workers
•  10. Control of sleep in orbital stations

The object of the invention is not previously burdening the sleep disturbed objective guidance of a written sleep log or diary o. Ä. through a technical realization for the ambulatory as well as clinical To replace and objectively assessable statements about the degree of a Sleep disturbance to come.  

program Description

The program SPIPP (sleep protocol) was to facilitate the evaluation manually guided sleep protocols and designed for automatic Data acquisition and processing extended by the sleep timer. When starting the program, a main menu appears, consisting of two parts which can be reached by switching from one menu to another. A comment line in the lower part of the screen indicates the function of the highlighted one Menu item down. The functions of some menu items will continue subdivided. When called, so a submenu, whose points turn are explained in corresponding comment line. Behind the current drive label, which appears in the picture on the top left is, is the name of the currently open file. Set some menu items certain provisions, without the invoked function not executable is. If such a message is not fulfilled, an error message appears Program indicating which of the conditions must first be fulfilled. For example, no protocol can be changed if no data file has been activated.

When switching from one main menu to the other, the activated data file becomes automatically closed, because for the functions of different Main menus also different data file types are necessary. The data were split to keep the size of the files low and the Compatibility of the data files as older versions of the program. you So you can select which data types are required for specific purposes are, but must for each necessary data type a reading function of the device carry out.

INPUT

This function is for manually entering the sleep logs. The first Picture prompts for the input of patient data. From the first 2 letters the name, the year of birth, the letter of the sex (m, w), the Number of weeks and the extension "ins" is composed of the filenames. While typing in a line, the usual buttons can be used for immediate Correction of errors can be used. Each line is called Enter completed. After completing a line, a following may be noticed  Errors can not be corrected immediately. It must first enter all information be completed.

So if an error has occurred when entering the data, so the point Repeat selected and all lines are run through again. Correct lines are confirmed with Enter. If you press to correct a line first a letter key, the old word is completely deleted; becomes on the other hand, first a function key z. B. cursor key pressed, the word remains as a basis and individual letters can be inserted or deleted become.

If all entries are correct, continue with Continue in the processing. Now a new input menu appears for each day. The week and the day are each displayed. The times out of the log questions 1-5 are taken, are entered in the appropriate line. The fifth line requires the number of nocturnal sleep interruptions. If the entered number is different from 0, a will appear additional menu for entering the duration of the individual faults. After completion of the daily input is by selecting the menu item New the Possibility of correcting incorrect entries. The correction is analogous to correct the patient data correction. Some content incorrect information however, are immediately noticed and displayed by the program (eg impossible times of day or letters in minutes) Due to the stupid work of data entry you can accidentally quickly get the Enter data one day at the wrong times and not notice it until the Day is really your turn. In that case, you should just finish the processed day. Afterwards you are back in the Line PgDn, New, Pgüp, you can reach the previous days again with Pgüp and can then correct them via New. With PgDn you leaf through again day by day forward. Overall, only so many weeks can be entered as agreed in the patient data menu at the beginning. For supplements you use the menu item Change of the main menu. When entering manually, only whole weeks can be entered. If The last week is incomplete, you can start by entering zeros for manage the remaining days. The input function automatically stops at the end of the last day and stores the data under the from the patient data in the above manner  created data file. Before the storage, however, only Check if a file with this name already exists. In this case a message appears with a decision menu. The old File can be overwritten by Overwrite, or it can be over New Filename a new filename with the extension "ins" can be entered. Also this is then checked before the data is stored. After returning to the main menu, the name of the file appears behind the Drive information on the screen.

LOAD

The main menu item Load offers the possibility to save data already saved are to call again or the data content of a sleep timer read. When selecting this function, a menu will appear with the points File from disc and Data from device.

Under the item File from disc you will find a window that contains the saved Data files (up to 100) displays. The section of the window covers only 10 Files, but can be moved up or down with cursor keys. In addition, the Home and End positioning functions can be used to connect to the Beginning or end of the list. The files appear in the window in the series of their storage on the disk. At the end of the list are still possible drive names to which switched can be.

By pressing Enter, the data file marked by the cursor becomes or drive selected and automatically returned to the main menu. The The drive name and the possibly selected data file are displayed in corresponding line on the screen. Became a drive Chosen, the load and file from disc must be called again to one Load data file from the selected volume. The file-from-disc function can be aborted at any time by ESC.

The function of the submenu Data from device is, as already mentioned, the Loading the data from a sleep timer. For this purpose, the device must over the connected to the COM 1 interface. The data is read immediately after the function has been called and if it is error-free Execution saved.  

To do this, the input field already known from the Input menu item appears the patient data. The only difference is that the Week number and start date already taken from the stored data was and can not be changed. As with all other charging functions the currently loaded data file will appear on the screen.

CHANGE

The change function of the main menu is similar to the input function. It is used for the subsequent modification of data files. For example Weeks are attached to the patient for more weeks of sleep protocol has performed, the week number is simply changed in the patient data menu. After you come to the individual daily overviews with Continue, appear the already stored days from the outset in the display. The cursor is located in the bottom menu bar, where between PgDn for the display the next day, PgÜp for the previous day's display and New for the day Change of the current day can be selected.

In the event that the week number was previously increased, the program goes to the last saved day automatically in the input mode as under Input over. The change function can also be easy to see for the individual times be used and canceled at any time with ESC.

Each time you exit the function, the data is saved again. As for the Case that the patient data has not been changed, the same filename the data under which the data was previously stored calls the Overwrite a menu that allows selection between Overwrite, New File and Cancil allows. The functions correspond to those of the similar menu at input. The Cancel function returns without saving the Changes.

PRINT

As the name of this function suggests, this is about the expression of the sleep protocol. For variable, needs-based Design became a submenu for presetting the print configuration created.

The Print item of this submenu causes only the actual printing in the preset configuration.  

This presetting is done with the function Coose pages. Here appears an overview of the pages of the protocol. The printing pages are with marked with a *. The selection corresponds to the saved one Standard Configuration. Enter can be used to * set or delete and so on the setting can be changed accordingly.

Use the cursor keys to go to the next lines. The Configuration is confirmed when leaving the menu by OK or Enter, whereas leaving with SDC preserves the old setting. The pressure of a sleep log is now set under Print in the Function done. The change of configuration will be made when exiting Canceled print menus.

If you want to print multiple files with the same setting, it is recommended Therefore, this as a standard with the function Save as standard of Save submenus. This setting is then on every call of Print active.  

VIEW

This function is used to display the entire sleep log on the Screen. With Enter the next page is called up to the whole Protocol were gone through.

OTHER MENU

As described in the first section, you can in this program switch between two menus. The item other menu therefore forms respectively the last function of both menus. With each switching may be activated files are closed and must be reloaded when needed again become.

INFO

A window will appear showing the information about the developer contains and also includes the possibility of entering the username. The username appears next to the developer name, Patient name and patient number on each sheet of the patient Protocol expression.

CYCLO GRAM

This menu function again has several subfunctions. In a submenu the dots File from disc, Data from device, Overall view and Choose day.

The first two functions are analogous to functions of the same name Main menu item Load. Do you want data from a device for the cyclogram representation could be used and maybe already data for the sleep protocol read under load, you still have to use the Data function again from device under Cyclogram. There are other data from this necessary for the device and these are also stored in another form. Everyone's like stored data files receive the extension "cyc". The data files are not compatible with the "ins" -files of the sleep protocol. From the loaded file, which is displayed again on the screen, can now under Overall view a cyclogram overview of all days shown become. If not all Cyclogramme fit on the screen, can with the Cursor functions are moved up or down. By entering  "P" prints the entire overview.

The cyclograms can be displayed in two time modes. The mode relatively time takes the bedtime walk of each day as a reference point and sets so the relative times to bedtime.

The absolute time mode, on the other hand, sets the curve as a function of the actual time of day. Between both modes you can always use "C" change.

Due to the rather inaccurate time axis division in this overview can Singlecyclograms can not be analyzed accurately. However, the purpose of this is the last function of the Cyclogram menu. By selecting the item Choose day prompts for a window for specifying the week and the day that is in the Single cycle should be displayed.

In the individual cycloogram are more accurate times of sleep interruptions with shown. Each single cyclogram can be printed. By PgDn and PgUp can be scrolled forward or backward by day, without the function to leave in between.  

Attachment 1

Annex 2

Annex 3

Annex 4

Annex 5

Annex 6

Table 1

SLEEP PROTOCOL

Annex 6

Table 2

Claims (8)

1. According to claim 1, the system is characterized in that

• - it from a registration unit with memory and interface for data transmission and
• - from a special program for data evaluation, the data stored in the registration unit exists (see Fig. 1).

2. According to claim 2, the registration unit of the system is characterized in that

• - the registration of the following sleep-wake parameters is enabled:
• - Sleep time
• - sleep duration
• - laytime
• - morning lull between waking up and getting up (useless couch time)
• - frequency of nocturnal awakening
• - Duration of nocturnal awakening
• - Time of going to bed
• - sleep contingency measure
• - Time of morning awakening
• - Time of getting up
• - The registration of the times after switching by one-button operation is done
• - The operating time of the registration unit is 24 hours
• - The registration unit an operation lt. Fig. 2 permits
• - The volume and frequency of the beep are individually adjustable by the user via the adjustment knob
• - The registration unit is a small portable device
• - The data stored in the registration unit can be connected via an interface to standardized PC technology.

3. According to claim 3, the system is characterized in that

• - The program for data analysis, the data stored in the registration unit, according to claim 2, the statistical analysis based on the examination day - night or month allows
• - allows the presentation of the day-night-related sleep-wake cyclogram
• - Cluster analysis, the data stored in the registration unit, according to claim 2, allows
• the biorhythmometric analysis, the data stored in the registration unit and the derived parameter Reff. (effective sleep time) according to claim 4 allows.

4. According to claim 4, the system is characterized in that

• - The data analysis program, the data stored in the registration unit, a possibility for biorhythmic analysis of the data contains.

5. According to claim 5, the system is characterized in that the program for biorhythmic data analysis the ability to verify Periodicities of the parameters according to claim 2 in examination sections of at least 14 days / nights. 6. According to claim 6, the system is characterized in that the program for Data analysis a classification of sleep-wake response groups according to Claim 7 allows. 7. According to claim 7, the system is characterized in that the program for biorhythmic data analysis allows a classification of the following reaction groups:

• First, a 7-day rhythm is always detectable for at least 4 weeks
  Reaction group: stable reaction
• Second, a 7-day rhythm is detectable alternating with a significant 2-4-day rhythm
  Reaction group: adaptive reaction
• Third, a 7-day rhythm is alternating with a significant rhythm ( 7 days detectable)
  Reaction group: relatively adaptive reaction
• Fourth, rhythms (or) 7-day or period decay are detectable.
  Reaction group: labile reaction

8. According to claim 8, the system is characterized in that the diagnosis of sleep disorders (sleep disordered - non-drowsy) after at least 4 weeks examination time according to the following classification, with the aid of formulated in claim 7 reaction groups, is carried out: Sleep healthy adaptive reaction group Sleep well until sleep problems or borderline: Sleep health - sleep disturbed relative adaptive reaction group Chronically or temporarily disturbed sleep stable reaction group Chronically disturbed sleep labile reaction group