Device for influencing sleep

Abstract

The device (1) is used to influence the sleep of a patient (8). It has a sensor unit (2) for detecting at least one measurement signal (28) recorded from the patient (8), a sleep-influence unit (3) for acting on the patient (8), and a control and evaluation unit (4). The control and evaluation unit (4) can be placed near the patient (8) in their home environment and can be connected to the sensor unit (2) and the sleep-influence unit (3). Furthermore, it is designed to evaluate the at least one measurement signal (28) and thereby recognize the patient's (8) current sleep state, and, depending on the recognized current sleep state, to control the sleep-influence unit (3) and thus influence the current sleep state.

Description

[0001] The invention relates to a device for influencing a patient's sleep.

[0002] Sleep-inducing devices are known to exist due to their use in inpatient medical settings, such as hospitals or sleep laboratories. These devices are complex and very complicated to use, meaning they can only be operated by trained personnel. They are unsuitable for use by the patient themselves or in the patient's home environment.

[0003] German patent DE 20 2022 106 837 U1 discloses a device for sleep diagnosis suitable for use in the patient's home environment. Electrodes applied by the patient to their scalp record electrophysiological signals, which are then transmitted to a multi-component control / evaluation unit for analysis. These electrophysiological signals include, in particular, electroencephalography (EEG) signals for recording the electrical activity of the brain, electrooculography (EOG) signals for recording eye movements, and / or electromyography (EMG) signals for recording muscle activity in the head region. This device is used exclusively for sleep diagnosis; it cannot be used to influence sleep.

[0004] The object of the invention is to provide a device of the type described above with improved properties compared to the prior art.

[0005] To solve this problem, a device according to the features of claim 1 is specified. The device according to the invention comprises a sensor unit for acquiring at least one measurement signal recorded from the patient, a sleep modification unit for influencing the patient, and a control and evaluation unit. The control and evaluation unit can be placed near the patient and in their home environment and can be connected to the sensor unit and the sleep modification unit. Furthermore, it is designed to evaluate the at least one measurement signal and thereby recognize the patient's current sleep state, and, depending on the recognized current sleep state, to control the sleep modification unit and thus influence the current sleep state.

[0006] The device is, in particular, an ambulatory device that can advantageously be operated by the patient themselves and used in their home environment. Preferably, the control and evaluation unit can be placed in the immediate vicinity of the patient. This also applies in particular to all other components of the device that are required for its proper operation.

[0007] The device thus enables the patient being treated to remain in their home environment, so that sleep is not negatively affected by unfamiliar external circumstances. This latter issue has frequently occurred in the past, as patients undergoing sleep therapy previously always had to go to the unfamiliar environment of a clinic or sleep laboratory. With the inventive, home-use sleep-inducing device, this necessity is eliminated for the first time.

[0008] Furthermore, the entire evaluation and control process preferably takes place at the patient's bedside. Advantageously, no computing unit located remotely from the patient, such as a cloud computer, is required for the evaluation and control. All evaluation and control steps are performed by the control and evaluation unit located close to the patient's bedside. In particular, the control and evaluation unit is designed to perform at least part, and preferably all, of the control and evaluation in real time. This allows the device to automatically initiate and implement measures to influence the sleep state precisely and in accordance with the detected current sleep state.

[0009] The sensor unit is specifically designed to capture at least one electrophysiological signal from the patient, such as an electroencephalography (EEG) signal to record the electrical activity of the brain, an electrooculography (EOG) signal to record eye movements, or an electromyography (EMG) signal to record muscle activity in the head region. Two or more electrophysiological signals can also be captured, in particular all three of those mentioned above. The sensor unit is specifically designed to capture additional signals, such as a body position signal and an acoustic signal of a noise produced by the patient during sleep, especially snoring. Furthermore, the sensor unit can also be designed to capture at least one additional, patient-independent signal, such as...to detect a light measurement signal, in particular that of ambient light.

[0010] The control and evaluation unit is designed to evaluate at least one measurement signal and from this to recognize the patient's current sleep state, to control the sleep influence unit depending on the recognized current sleep state and in particular to cause the patient to be exposed to an influence signal in order to influence the current sleep state.

[0011] The control and evaluation unit is, in particular, multi-part or multi-component and / or at least partially, preferably entirely, designed as a mobile unit. It can include, as sub-components, at least one preprocessing unit, which can be placed, for example, near the electrodes used for signal acquisition, such as on the patient's head, and a computing unit, which is particularly portable and can be placed at the patient's bedside, such as a tablet computer, a smartphone, or a laptop computer. A data or communication connection, in particular a wireless data or wireless communication connection, for example according to the Bluetooth standard, exists between the individual sub-components of the control and evaluation unit.

[0012] Advantageous embodiments of the device result from the features of the claims dependent on claim 1.

[0013] A particularly advantageous design is one in which the sleep modification unit is designed to influence the patient acoustically, especially via headphones, or tactilely, especially via a vibrating wristband, or both acoustically and tactilely. This allows for a particularly simple and at the same time very effective sleep modification.

[0014] According to another advantageous embodiment, the control and evaluation unit is designed to expose the patient to an acoustic stimulating signal via the sleep induction unit. This acoustic stimulating signal can be a sequence of tones, a noise signal, or a tone pulse. The tones can, in particular, be a relaxing melody or a relaxing narrative. This, in each case, supports falling asleep. The noise signal can have a noise frequency bandwidth that lies primarily within the human audible frequency range, i.e., from 20 Hz to 20 kHz. By applying noise signals of varying compositions, targeted stimulation of sleep stages can be achieved. For example, exposure to white noise, i.e., with essentially the same volume or signal amplitude across the entire noise frequency bandwidth, supports or improves falling asleep.Deep sleep is supported or improved by exposure to pink noise, i.e., noise with a decreasing volume or signal amplitude across the noise frequency bandwidth, essentially at a rate of 1 / f. Here, f denotes the frequency. Furthermore, pink noise is used during the REM (Rapid Eye Movement) sleep stage to induce, for example, a sleep stage transition or awakening. Alternatively, brown noise (decreasing at a rate of 1 / f) can be used. 2 Pink and white noise can be used in combination or individually in the described scenarios. The tone pulse can be designed as an essentially mono-frequency tone pulse. This can, for example, trigger waking up or a change in sleep stage.

[0015] According to a further advantageous embodiment, the control and evaluation unit is designed to subject the patient to an acoustic stimulus signal via the sleep induction unit, the volume of which is above or below at least one individual acoustic threshold of the patient. Preferably, there can be three acoustic thresholds: the hearing threshold, the arousal threshold, and the awakening threshold. In this context, the hearing threshold denotes the lowest volume perceptible to the patient while awake, the arousal threshold the lowest volume that leads to arousal, and the awakening threshold the lowest volume that induces wakefulness in the patient. In general, all thresholds are individual and dependent on the frequency components of the acoustic stimulus. The hearing threshold is at the lowest volume, followed by the arousal and awakening thresholds.A deliberate awakening can be induced by means of an acoustic stimulus signal that is at least as loud as the arousal threshold. An arousal is triggered by an acoustic stimulus signal that is at least as loud as the arousal threshold but lower than the arousal threshold. This allows, in particular, a deliberate change in sleep stages to be induced. With a stimulus signal that is below the arousal threshold but at least as loud as the hearing threshold, no awakening response or arousal occurs. Instead, such an acoustic stimulus signal serves primarily to selectively stimulate a sleep stage. In this way, the intensity of the sleep stage can be increased and / or its duration extended.Since the individual acoustic thresholds depend in particular on the frequency components of the influencing signal, there may be more than three individual acoustic thresholds that should be given preferential consideration in this context.

[0016] According to another advantageous configuration, the control and evaluation unit is designed to determine at least one individual acoustic threshold of the patient. Determining the individual hearing threshold can be part of an initial calibration routine, which the patient completes while still awake. The individual arousal threshold, on the other hand, is preferably determined while the patient is asleep, for example, by gradually increasing the volume, starting from the hearing threshold, until the individual arousal threshold is reached, which can be recognized, for example, by a subsequent change in sleep stage.The individual arousal threshold can also be preferably determined while the patient is asleep, for example by means of a deliberately induced arousal reaction, whereby the volume is increased in particular until the individual arousal threshold is reached, which can be recognized by the subsequent waking up of the patient.

[0017] According to another advantageous embodiment, the control and evaluation unit is designed to subject the patient to an acoustic stimulating signal via the sleep modification unit. The volume of this signal is adjustable and, in particular, increases, preferably until an arousal, a change in sleep stage, or awakening occurs. The initial volume can be several times the patient's individual hearing threshold. The degree of sleep modification can be optimized by adjusting the volume.

[0018] According to a further advantageous embodiment, the control and evaluation unit is designed to determine the effect of a measure initiated by the sleep influencing unit on the patient's sleep and, if an undesirable or insufficient effect is detected, to modify the measure initiated by the sleep influencing unit. In the case of an acoustic influencing signal, this modification can, in particular, consist of increasing or decreasing its volume, which can be accomplished very easily. The control and evaluation unit is specifically designed to continuously determine the effect of a measure initiated by the sleep influencing unit and to adjust or modify it based on the effect, preferably in real time.

[0019] According to a further advantageous embodiment, the at least one measurement signal is an EEG measurement signal, and the control and evaluation unit is designed to subject the patient to an acoustic influence signal in the form of a tone sequence generated by the control and evaluation unit. This tone sequence contains frequency components and / or amplitude values ​​derived from those of the EEG measurement signal evaluated by the control and evaluation unit. This is, in particular, a feedback process. This supports relaxation and sleep onset. The patient remains awake during this intervention. The frequency components of the feedback acoustic influence signal are derived, in particular, from those of the acquired EEG measurement signal.For example, to determine the acoustic feedback signal, the frequencies of a frequency subrange of the EEG measurement signal are scaled by a factor. The frequency subrange of the EEG measurement signal considered here lies, for example, between 8 Hz and 32 Hz. The factor can, for example, have a uniform value of 10, so that the frequency components of the feedback acoustic feedback signal in this example lie between 80 Hz and 320 Hz. The signal amplitudes of the feedback acoustic feedback signal can be determined, in particular, in an analogous manner from those of the acquired EEG measurement signal.

[0020] According to a further advantageous configuration, the control and evaluation unit is designed to determine the patient's various sleep stages in real time and, in particular, with high precision. This makes it possible to immediately initiate appropriate sleep intervention measures via the sleep intervention unit if necessary. The sleep stages recorded by the control and evaluation unit include, in particular, at least the sleep onset phase, the REM (Rapid Eye Movement) sleep phase, the light sleep phases (N1, N2), the deep sleep phase (N3), and the wake phase (e.g., WASO (Wake after Sleep Onset)). The sleep stages are recorded, in particular, by means of FFT (Fast Fourier Transform) analysis of the at least one measurement signal and / or pattern recognition in the at least one measurement signal.Pattern recognition can be used, in particular, to check whether an EEG measurement signal contains signal areas that exhibit the temporal signal patterns typical of sleep spindles and / or K-complexes, and which indicate a light sleep phase (N1, N2). A REM sleep phase is characterized in particular by rapid, opposing eye movements, which can be preferably identified using recorded EOG measurement signals.

[0021] According to another advantageous embodiment, the control and evaluation unit is designed to detect a deep sleep phase and, during this phase, to expose the patient to an acoustic stimulating signal in the form of a noise signal via the sleep modification unit. This noise signal is specifically pink noise.

[0022] This can lead in particular to a lengthening and / or an increase in the intensity of deep sleep, which can be beneficial, for example, for the treatment of early dementia (Alzheimer's).

[0023] According to a further advantageous embodiment, the at least one measurement signal is an EEG measurement signal, and the control and evaluation unit is designed to detect the onset of a delta signal component in the EEG measurement signal, particularly in real time. The onset of a delta signal component indicates, in particular, the beginning of a deep sleep phase. Detection is achieved, for example, by means of an FFT analysis and an evaluation of the frequency content of the EEG measurement signal, whereby a delta signal component lies in a frequency range between 0.5 Hz and 3.5 Hz (= delta frequency interval), and a high delta component in the spectrum typically indicates a deep sleep phase. In addition to the EEG measurement signal, other measurement signals, such as an EOG measurement signal and / or an EMG measurement signal, can also be considered or evaluated to detect the onset of a deep sleep phase.

[0024] According to a further advantageous embodiment, the control and evaluation unit is designed to expose the patient to an acoustic stimulating signal via the sleep induction unit at the beginning of a deep sleep phase. The acoustic stimulating signal is, in particular, a noise signal, preferably pink noise, preferably with a duration of 50 ms and, in particular, with a volume or signal amplitude below the arousal threshold and above the hearing threshold. This results in particularly efficient deep sleep support.

[0025] According to a further advantageous embodiment, the control and evaluation unit is designed to apply an acoustic stimulating signal to the patient via the sleep induction unit, synchronously with a rising edge caused by the delta signal component in the EEG measurement signal. Again, the acoustic stimulating signal is, in particular, a noise signal, preferably pink noise, preferably with a duration of 50 ms and with a volume or signal amplitude below the arousal threshold and above the hearing threshold. This measure also results in very efficient deep sleep support.

[0026] According to a further advantageous embodiment, the control and evaluation unit is designed to detect a REM sleep phase, in particular the onset of a REM sleep phase, and to subject the patient to an acoustic stimulating signal by means of the sleep induction unit, such that a sleep stage change, detected in particular by the control and evaluation unit, or an awakening, also detected in particular by the control and evaluation unit, occurs. In this application as well, the acoustic stimulating signal is in particular a noise signal, preferably repeating pink noise, preferably with a duration of 50 ms each. There is a pause of approximately 1 second between two noise signal tones.The control and evaluation unit is specifically designed to increase the signal amplitude or volume of the noise signal if an arousal associated with a sleep stage transition or awakening does not occur after, in particular, 10 noise tones. The signal amplitude or volume of the noise signal is, in particular, at least above the arousal threshold (for a sleep stage transition) and, if necessary, also above the hearing threshold (for awakening). This targeted deprivation of REM sleep, or sleep deprivation in general, has a particularly beneficial effect in the treatment of depression. In this way, REM sleep deprivation can be carried out very efficiently, yet simply and cost-effectively, over an extended period in the patient's home environment.

[0027] According to another advantageous embodiment, the control and evaluation unit has an electrical energy storage device whose storage capacity is dimensioned to operate the device for at least five nights. The device can therefore be operated for a sufficiently long period without requiring recharging or replacement of the energy storage device or any other service. This simplifies handling by the patient.

[0028] According to a further advantageous embodiment, the control and evaluation unit is designed to perform an initial calibration routine to determine the quality of the at least one measurement signal. Specifically, during the calibration routine, the at least one measurement signal is acquired at eye and eyelid positions specified by the control and evaluation unit for the patient, particularly during eye movements to the left, right, up, and down, as well as with the eyes open and closed. Furthermore, during the calibration routine, the position of the measuring electrode(s) used for acquiring the at least one measurement signal is photographed and checked against the photograph.

[0029] According to a further advantageous embodiment, the control and evaluation unit is designed to determine the electrode impedance of an electrode used to acquire the at least one measurement signal. This advantageously allows artifacts caused by temporarily poor electrode impedances to be taken into account during the evaluation, i.e., in particular, detected and excluded from the analysis.

[0030] According to a further advantageous embodiment, the control and evaluation unit is designed to record and store, preferably in real time, a stimulating signal, particularly acoustic or tactile, generated by the sleep modification unit and delivered to the patient. This facilitates verification of the stimulating measure and, in particular, modification of the stimulating signal should the desired effect not occur.

[0031] Further features, advantages, and details of the invention will become apparent from the following description of exemplary embodiments with reference to the drawing. It shows: Fig. 1 a block diagram of an embodiment of a sleep induction device with a sensor unit, a sleep induction unit and a control and evaluation unit, Fig. 2 a partial representation of an embodiment of a sleep-inhibiting device according to Fig. 1 with measuring electrodes attached to the head of a patient to record electrophysiological measurement signals as part of the sensor unit, a headphone as a sleep induction unit and a preprocessing unit as part of the control and evaluation unit, Fig. 3 to 5 Examples of frequency responses of the sleep influence unit according to Fig. 1 or Fig. 2 acoustic influence signals in the form of various noise signals supplied to the patient, and Fig. 6 one from the sensor unit according to Fig. 1 or Fig. 2. Recorded EEG measurement signal with marked times for the exposure of the patient to acoustic influence signals.

[0032] Corresponding parts are in the Fig. Reference numerals 1 to 6 are provided with the same reference numerals. Details of the embodiments described in more detail below may also constitute an invention in themselves or be part of an invention.

[0033] In Fig. Figure 1 shows an embodiment of a sleep induction device 1 in a block diagram. The sleep induction device 1 comprises a sensor unit 2, a sleep induction unit 3, and a control and evaluation unit 4.

[0034] Sensor unit 2 contains several sensors 5, 6, and 7 designed to record measurement signals related to the sleep behavior of patient 8. Sensors 5 are designed to record electrophysiological measurement signals and include several measuring electrodes 9, 10, 11, and 12, which are to be placed on the scalp of patient 8. According to the illustration of Fig. 2. Measuring electrode 9, which is specifically designed as a ground electrode, is to be placed behind one of the patient's 8 ears. Measuring electrode 10 is to be placed to the right of the eyes, and measuring electrode 11 is to be placed opposite, to the left of the eyes. The central measuring electrode 12 is to be placed, specifically, in the center of the forehead. Measuring electrodes 9 to 12 each detect electrical potentials. The potential differences between any two of the measuring electrodes 9 to 12 are recorded as electrophysiological measurement signals.The potential difference between the central measuring electrode 12 and the ground electrode 9 provides an EEG (electroencephalography) measurement signal for recording the electrical activity of the brain, i.e., brain waves; the potential difference between the left measuring electrode 11 and the central measuring electrode 12 provides an EOG (electrooculography) measurement signal for the movement of the left eye; the potential difference between the right measuring electrode 10 and the central measuring electrode 12 provides another EOG measurement signal for the movement of the right eye; and the potential difference between the right measuring electrode 10 and the left measuring electrode 11 provides an EMG (electromyography) measurement signal for recording muscle activity in this head region. In addition, the sensor unit contains two further sensors, namely at least sensors 6 and 7. Sensor 6 is designed as a position sensor and serves to record the head position and / or head movements of the patient 8.Sensor 7 is an acoustic sensor used to detect snoring sounds from patient 8. Additional sensors may be present, such as a light sensor to detect ambient light. The measurement signals acquired by sensors 5 to 7 are transmitted to the control and evaluation unit 4. A unidirectional or bidirectional communication link 13 is available for this purpose, implemented either as a wired communication link 17 or as a wireless communication link, for example, according to the Bluetooth standard. In the illustrated embodiment, communication between sensors 5 or their measuring electrodes 9 to 12 and the control and evaluation unit 4 is wired, while communication between the other sensors 6 and 7 and the control and evaluation unit 4 is wireless. However, other configurations or variations are also possible.

[0035] In the illustrated embodiment, the control and evaluation unit 4 is designed in multiple parts. It comprises a preprocessing unit 14 and a mobile computing unit 15 in the form of a tablet computer. A communication link 16 also exists between the preprocessing unit 14 and the mobile computing unit 15, which in the illustrated embodiment is preferably implemented as a wireless communication link according to the Bluetooth standard. It is, in particular, bidirectional. According to the illustration of Fig. 2 The preprocessing unit 14 is exposed to the central measuring electrode 12, and an electrical communication link is simultaneously established between these two components. A wired communication link 17 exists to each of the remaining measuring electrodes 9, 10, and 11.

[0036] The sleep modification unit 3 is designed to apply a modification signal 18 to the patient 8. This modification signal 18 can be acoustic or tactile. It is also possible to apply both types of modification, i.e., both acoustic and tactile. For delivering an acoustic modification signal 18, the sleep modification unit 3 includes headphones 19; for delivering a tactile modification signal 18, it includes a vibrating wristband 20. There are embodiments in which the sleep modification unit 3 is designed specifically as either only the headphones 19 or only the vibrating wristband 20. In the embodiment described in Fig. In the embodiment shown in Figure 2, the sleep influencing unit 3 is implemented by the headphones 19. A unidirectional or bidirectional communication link 21 exists between the sleep influencing unit 3 and the control and evaluation unit 4, which in the illustrated embodiment is implemented as a wireless communication link according to the Bluetooth standard.

[0037] Patient 8 interacts with the various units of the sleep modification device 1. In the case of sensor unit 2, this interaction relates to physical quantities that can be detected on the patient by sensors 5 to 7 of sensor unit 2. This interaction 22 is thus directed from patient 8 to sensor unit 2. It is, in particular, unidirectional. The interaction between the sleep modification unit 3 and patient 8 is also, in particular, unidirectional. As already described, it is determined by the modification signal 18, by means of which patient 8 is subjected to the sleep modification unit 3. In contrast, the interaction 23 between patient 8 and the control and evaluation unit 4 is bidirectional. Patient 8 can receive information from the control and evaluation unit 4, for example, visually or audibly.Conversely, the patient can send 8 inputs to the control and evaluation unit 4, for example as part of a calibration routine to be carried out before the actual use of the sleep influencing device 1.

[0038] During this calibration routine, at least one of the individual acoustic thresholds of patient 8, namely the hearing threshold, and the basic settings of the sleep-inhibiting device 1 resulting from the current conditions prevailing in patient 8 are determined. During the calibration routine, the position and placement of the measuring electrodes 9 to 12 applied by patient 8 are also checked, in particular by means of a photograph. The arousal threshold and the awakening threshold, other individual acoustic thresholds of patient 8, are preferably also determined, but not during the initial calibration routine, rather during a sleep phase of patient 8a.

[0039] The sleep modification device 1 is characterized by the fact that it can be operated by the patient 8 themselves and, above all, used in their home environment. All evaluations of the recorded measurement signals are performed by the control and evaluation unit 4, particularly in real time. The sleep modification device 1 is specifically designed to determine the sleep stages of the patient 8 in real time and with high accuracy. No remotely located, high-performance computer systems, such as a cloud computer, are required for this evaluation or determination. Rather, all evaluation steps can be carried out in the control and evaluation unit 4. This results in the further advantage of being able to react very quickly, and again in real time, to any identified need to influence or change the current sleep stage of the patient 8.The influencing signal 18 can then be delivered quickly and precisely to patient 8, thus selectively inducing the desired influence on patient 8's sleep state. All of this is possible using the sleep influencing device 1 in patient 8's familiar home environment.

[0040] The sleep influencing device 1 has various application areas for influencing the sleep state of patient 8.

[0041] In the first application scenario, patient 8 is still awake. In this case, the sleep induction device 1 supports the patient's sleep-inducing behavior, for example, by presenting patient 8 with the induction signal 18 in the form of a relaxation melody or a relaxation narrative. Alternatively, the induction signal 18 can also be derived from the recorded EEG measurement signal, for example, by using frequency components and / or amplitude values ​​of the EEG measurement signal, after processing appropriate to patient 8's condition, to generate the induction signal 18. The induction signal 18 then represents a feedback signal that also serves to relax patient 8.

[0042] In a second application, the sleep-inducing device 1 serves to support or prolong a sleep stage of patient 8. In particular, after detecting a deep sleep phase in patient 8, the influencing signal 18 can be delivered in the form of an acoustic noise signal. This can advantageously prolong and / or increase the intensity of deep sleep, which is promising for the treatment of early dementias, such as Alzheimer's disease. The acoustic noise signal with which patient 8 is exposed to support a deep sleep phase is, in particular, pink noise 24. A frequency response of this pink noise 24 is shown in the diagram of Fig. Figure 4 shows the human-audible frequency range from 20 Hz to 20 kHz with logarithmic frequency scaling. The amplitude or loudness of the noise signal in the form of pink noise 24 decreases with 1 / f over the frequency f, specifically at 20 dB / decade. Fig. 3 and Fig. Figure 5 shows other possible acoustic noise signals that can also be supplied to patient 8 via the sleep modification unit 3 as a modification signal 18. In the case of the Fig. The noise signal shown in Figure 3 is white noise 25, in which the signal amplitude or volume remains essentially constant across the entire frequency range. In the case of the noise signal shown in Figure 3, the noise signal is white noise 25, in which the signal amplitude or volume remains essentially constant across the entire frequency range. Fig. The amplitude or volume of the brown noise shown in Figure 5 decreases more sharply with frequency f than that of the pink noise shown in Figure 24. Fig. 4, namely with 1 / f 2 , especially at 40 dB / decade.

[0043] Pink noise is used to support the deep sleep phase. It is particularly advantageous if the patient is exposed to such an influencing signal at the right time. The best effect in supporting deep sleep is achieved when the influencing signal in the form of pink noise is applied synchronously with a rising edge of a delta signal component in the EEG measurement signal. These particularly effective times, which are synchronous with the rising edge of the delta signal component in the EEG measurement signal, are shown in the Fig. Section 6 of such an EEG measurement signal 28 is marked. The EEG measurement signal 28 is shown in the diagram according to Fig.The data is plotted over time t. At each of the marked time points 27, the influence signal 18, in the form of pink noise 24, is delivered to the patient 8 for a duration of approximately 50 ms. This results in very effective support of deep sleep.

[0044] In a third application, the sleep modification device 1 serves not to support, but to prevent or modify a sleep stage, specifically a REM (rapid eye movement) sleep phase. As soon as such a REM sleep stage is detected in the control and evaluation unit in this application, the patient 8 is supplied with the modification signal 18 to terminate the REM sleep phase, for example, by deliberately inducing an awakening of the patient 8 or by an arousal that causes a change in the sleep stage without complete awakening. In this application as well, the modification signal 18 is an acoustic noise signal in the form of pink noise 24 with a noise tone duration of 50 ms. The injection of these noise tones is repeated cyclically.Furthermore, the control and evaluation unit 4 uses the recorded measurement signals to check whether the desired outcome, namely the termination of the REM sleep phase, has been achieved. If this is not the case after a certain number of pink noise tones, for example, ten consecutive tones, the volume or signal amplitude of the pink noise 24 is increased. This increase continues, in particular, until the desired transition away from the REM sleep phase occurs. The resulting deprivation of REM sleep, or sleep deprivation, induced by the sleep-inhibiting device 1 is an effective measure in the therapy of depression.

[0045] Overall, the sleep modification device 1 can be used in various ways to influence the sleep state of patient 8. Each application results in a beneficial effect for patient 8. A particularly noteworthy advantage is that the sleep therapy effected by the sleep modification device 1 can take place not in an unfamiliar environment, such as a clinic or sleep laboratory, but in the familiar home environment. Therefore, undesirable influences on patient 8's sleep behavior, which can otherwise be caused by an unfamiliar environment, are advantageously irrelevant with the sleep modification device 1. Furthermore, the complete independence of the sleep modification device 1 from external processing units is beneficial. All evaluation and control steps are performed locally and, in particular, in real time by the control and evaluation unit 4.This prompted the development of the sleep modification device 1. Therefore, it offers a very efficient, simple, and cost-effective method for sleep therapy. QUOTES INCLUDED IN THE DESCRIPTION

[0000] This list of documents cited by the applicant was automatically generated and is included solely for the reader's convenience. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions. Cited patent literature

[0000] DE 20 2022 106 837 U1

[0003]

Claims

[1] Device comprising for influencing a patient’s sleep (8) a) a sensor unit (2) for recording at least one measurement signal (28) taken from the patient (8), b) a sleep modification unit (3) for acting on the patient (8), and c) a control and evaluation unit (4) wherein d) the control and evaluation unit (4) d1) can be placed in the vicinity of the patient (8) and in his home environment, and d2) is connectable to the sensor unit (2) and the sleep influencing unit (3), and is designed to be, d3) to evaluate at least one measurement signal (28) and to identify the patient's current sleep state (8) from it, and d4) depending on the detected current sleep state, to control the sleep control unit (3) and thus influence the current sleep state. [2] Device according to claim 1,characterized by , that the sleep influencing unit (3) is designed to act acoustically or tactilely or both acoustically and tactilely on the patient (8). [3] Device according to claim 1 or 2, characterized by , that the control and evaluation unit (4) is designed to subject the patient (8) to an acoustic influence signal (18) by means of the sleep influence unit (3), wherein the acoustic influence signal (18) is designed as a sequence of tones, as a noise signal (24; 25; 26) or as a tone impulse. [4] Device according to any one of the preceding claims, characterized by , that the control and evaluation unit (4) is designed to subject the patient (8) to an acoustic influence signal (18) via the sleep influence unit (3), the loudness of which is above or below an individual acoustic threshold of the patient (8). [5] Device according to any one of the preceding claims, characterized by , that the control and evaluation unit (4) is designed to determine at least one individual acoustic threshold of the patient (8). [6] Device according to any one of the preceding claims, characterized by , that the control and evaluation unit (4) is designed to subject the patient (8) to an acoustic influence signal (18) by means of the sleep influencing unit (3), the volume of which is variable and in particular increases, preferably until an arousal, a change of sleep stage or an awakening occurs. [7] Device according to any one of the preceding claims, characterized by, that the control and evaluation unit (4) is designed to determine the effect of a measure initiated by the sleep influencing unit (3) on the sleep of the patient (8) and, in the event of an undesirable or insufficient effect being detected, to change the measure initiated by the sleep influencing unit (3). [8] Device according to any one of the preceding claims, characterized by , that the at least one measurement signal is an EEG measurement signal (28) and the control and evaluation unit (4) is designed to subject the patient (8) to an acoustic influence signal (18) in the form of a tone sequence generated by the control and evaluation unit (4) by means of the sleep influencing unit (3), wherein the tone sequence has frequency components and / or amplitude values ​​derived from those of the EEG measurement signal (28) evaluated by the control and evaluation unit (4). [9] Device according to any one of the preceding claims, characterized by , that the control and evaluation unit (4) is designed to determine different sleep stages of the patient (8) in real time. [10] Device according to any one of the preceding claims, characterized by , that the control and evaluation unit (4) is designed to detect a deep sleep phase and to subject the patient (8) during the deep sleep phase to an acoustic influence signal (18) in the form of a noise signal (24) by means of the sleep influence unit (3). [11] Device according to any one of the preceding claims, characterized by , that the at least one measurement signal is an EEG measurement signal (28) and the control and evaluation unit (4) is designed to detect the beginning of a δ-signal component in the EEG measurement signal (28), especially in real time. [12] Device according to claim 11, characterized by, that the control and evaluation unit (4) is designed to subject the patient (8) to an acoustic influence signal (3) by means of the sleep influence unit (3) at the beginning of a deep sleep phase. [13] Device according to claim 11 or 12, characterized by , that the control and evaluation unit (4) is designed to subject the patient (8) to an acoustic influence signal (18) synchronously with a rising edge caused by the δ-signal component in the EEG measurement signal (28) by means of the sleep influencing unit (3). [14] Device according to any one of the preceding claims, characterized by , that the control and evaluation unit (4) is designed to detect a REM sleep phase and to subject the patient (8) to an acoustic influence signal (18) by means of the sleep influence unit (3) in such a way that a change of sleep stage or an awakening occurs. [15] Device according to any one of the preceding claims, characterized by , that the control and evaluation unit (4) has an electrical energy storage device whose storage capacity is dimensioned for operation of the device for at least five nights. [16] Device according to any one of the preceding claims, characterized by , that the control and evaluation unit (4) is designed to perform an initial calibration routine to determine the quality of the at least one measurement signal (28). [17] Device according to any one of the preceding claims, characterized by , that the control and evaluation unit (4) is designed to determine an electrode impedance of an electrode (9, 12) used to detect the at least one measurement signal (28). [18] Device according to any one of the preceding claims, characterized by, that the control and evaluation unit (4) is designed to record and store an influence signal (18) generated by the sleep influencing unit (3) and supplied to the patient (8), preferably in real time.

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