Device for influencing sleep

Abstract

The invention relates to a device (1) which 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 influencing unit (3) for acting on the patient (8), and a control and evaluation unit (4). The control and evaluation unit (4) can be placed in the vicinity of the patient (8) and in their domestic environment and can be connected to the sensor unit (2) and the sleep influencing unit (3). Furthermore, it is designed to evaluate the at least one measurement signal (28) and to identify a current sleep state of the patient (8) therefrom, and to control the sleep influencing unit (3) on the basis of the identified current sleep state and hence influence the current sleep state. - Fig. 1 -

Description

[0001] Device for influencing sleep

[0002] The present patent application claims priority from German patent application DE 10 2024 208 367.4, the contents of which are incorporated herein by reference.

[0003] The invention relates to a device for influencing a patient's sleep.

[0004] 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.

[0005] German patent DE 20 2022 106 837 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.The object of the invention is to provide a device of the type described above with improved properties compared to the prior art.

[0006] 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.

[0007] 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.

[0008] 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.

[0009] 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.

[0010] Here and in the following, "in real time" is understood to mean, in particular, a processing latency of less than 1000 ms, especially less than 250 ms. For example, the measurement of a physical parameter, such as an electrophysiological measurement signal, the determination of a current sleep state, such as a current sleep phase, and / or the control of the sleep influencing unit, preferably the complete control and evaluation by the control and evaluation unit, can be carried out in real time.

[0011] 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.

[0012] 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.

[0013] 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.

[0014] It is also possible for the control and evaluation unit to be a single component. In particular, it can be positioned entirely on the patient's head. This enables particularly fast, and especially latency-free, processing and evaluation of the at least one measurement signal, as well as control of the sleep modification unit.

[0015] Advantageous embodiments of the device result from the features of the claims dependent on claim 1.

[0016] A particularly advantageous design is one in which the sleep modification unit is configured to influence the patient acoustically, especially via headphones, tactilely, especially via a vibrating wristband, or via transcranial alternating current stimulation. The influence on the patient can be both acoustic and tactile, or both acoustically and via transcranial alternating current stimulation. A combination of tactile stimulation and transcranial alternating current stimulation, or combinations of all three stimulation types, is also possible. This allows for particularly simple and highly effective sleep modification.

[0017] Suitable headphones for acoustic stimulation include in-ear headphones, over-the-ear headphones, and / or bone conduction speakers. Transcranial alternating current stimulation (tACS) is particularly suitable for stimulating cortical neurons and improving deep sleep-typical brainwaves, especially so-called 5-waves, and / or memory consolidation. Preferably, the stimulation frequency, amplitude, and / or phase of tACS can be adapted to patient-specific brainwave activity, preferably measured in real time, for example, during deep sleep.

[0018] Transcranial alternating current stimulation can be performed, in particular, with a current intensity between 250 pA and 500 pA.

[0019] Particularly preferred for transcranial alternating current stimulation are stimulation electrodes that are separate or independent from other electrodes of the sleep influencing device, for example measuring electrodes for measuring an EEG measurement signal.

[0020] An arrangement of stimulation electrodes for transcranial alternating current stimulation has proven particularly suitable, in which one or more stimulation electrodes in the forehead region interact with one or more stimulation electrodes in the neck region. The at least one stimulation electrode on the stimulating side and the at least one stimulation electrode on the neck side serve alternately as a current source and current sink, respectively. Preferably, the stimulation electrodes are arranged symmetrically with respect to a median sagittal plane of the patient's head, in particular centrally in the neck and / or on the forehead (one stimulation electrode on the stimulating side and one on the neck side) or symmetrically with respect to the center of the stimulating side or the center of the neck (two or more, in particular exactly two, stimulation electrodes).This arrangement has proven particularly suitable for stimulating brain regions that are especially relevant for deep sleep and the corresponding brainwave activity. The stimulation current flows primarily through the prefrontal cortex, the parietal / occipital cortex, and / or other subcortical regions.

[0021] In a favorable configuration, the control and evaluation unit is designed to influence the patient using both acoustic and transcranial alternating current stimulation, with the acoustic and transcranial alternating current stimulation being offset by a predetermined time interval. This enables a synergistic combination of the physiologically complementary acoustic and transcranial alternating current stimulation. Simultaneously, the predetermined time interval prevents sensory overstimulation of the patient, cortical desynchronization, and unintended interactions between different stimulation pathways.

[0022] The combination of acoustic stimulation and transcranial alternating current stimulation (tACS) has proven particularly beneficial for supporting deep sleep. Acoustic stimulation, especially in the form of short acoustic pulses such as pink noise, can induce thalamocortical coupling, thereby enhancing endogenous brainwave activity during deep sleep. TACS can stimulate cortical neurons and support deep sleep brainwave activity as well as memory consolidation. The combination of acoustic and TACs therefore primarily results in the stimulation of cortical neurons followed by the activation of thalamocortical pathways, thus amplifying endogenous brainwave activity.This particularly supports sensory-induced (so-called bottom-up) activation and direct cortical (so-called top-down) activation.

[0023] The acoustic stimulation and the transcranial alternating current stimulation are offset by a predetermined time interval. In particular, the acoustic stimulation and the transcranial alternating current stimulation can begin or commence at different times, respectively, by the prescribed time interval. Preferably, the acoustic stimulation and the transcranial alternating current stimulation have different durations. Particularly preferably, the transcranial alternating current stimulation and the acoustic stimulation overlap, at least temporarily. For example, the acoustic stimulation can commence after the transcranial alternating current stimulation and have a shorter duration.

[0024] A predetermined time interval between the start of transcranial alternating current stimulation and acoustic stimulation can, for example, be between 5 ms and 500 ms, particularly between 60 ms and 500 ms, or particularly between 125 ms and 200 ms. The time interval can, for example, be fixed or adjusted depending on the patient's physiological measurements.

[0025] 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 a 5-signal component, in particular the beginning of a 5-signal component in the EEG measurement signal, especially in real time. The beginning of a 5-signal component indicates, in particular, the beginning of a deep sleep phase. Detection is achieved, for example, by means of FFT analysis and / or so-called phase-locked loop (PLL) algorithms and an evaluation of the frequency content of the EEG measurement signal, whereby a 5-signal component lies in a frequency range between 0.5 Hz and 3.5 Hz, in particular between 0.5 Hz and 2 Hz (= 5-frequency interval), and a high 5-signal 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 taken into account.They are evaluated to identify the beginning of a deep sleep phase.

[0026] As mentioned, the 5-wave component is characteristic of deep sleep. This component is characterized by synchronized, low-frequency brain waves. It is therefore also referred to as slow-wave activity (SWA). Similarly, deep sleep is also called slow-wave sleep (SWS) or 5-wave sleep. The term N3 or sleep stage N3 is also commonly used for deep sleep.

[0027] According to a further advantageous embodiment, the control and evaluation unit is designed to determine the frequency, amplitude, and / or phase of the 5-signal component in the EEG measurement signal. For example, a frequency component particularly characteristic of the 5-signal component can be used to determine the 5-frequency, amplitude, and / or phase, such as a dominant frequency component, a median frequency, and / or a center frequency. Preferably, the 5-frequency, amplitude, and phase are determined based on a dominant frequency of the 5-signal component of the respective patient. Hereinafter, the frequency component of the 5-signal component used to determine the 5-frequency, amplitude, and / or phase, in particular the dominant frequency component, is referred to as the 5-main wave.The term "5-wave main wave" refers specifically to a patient-specific frequency component of the 5-wave signal, in particular a dominant frequency component, a median frequency, and / or a center frequency. A dominant frequency component is, in particular, the frequency of the 5-wave signal that contributes significantly to the overall 5-wave activity, for example, the frequency with the greatest amplitude. The 5-wave main wave typically has a frequency between 0.5 Hz and 2.0 Hz. Therefore, the 5-wave frequency, 5-wave amplitude, and / or 5-wave phase are the frequencies, amplitudes, and phases, respectively, of the 5-wave main wave. The 5-wave phase is, in particular, the current phase angle of the 5-wave main wave.

[0028] The determination of the 5-wave main wave, in particular its 5-frequency, can be carried out, for example, as part of a calibration procedure, such as by measuring the patient's limbal activity during a night in which no stimulation has yet taken place. It is also possible to determine the 5-wave main wave, in particular its 5-frequency, 5-amplitude, and / or 5-phase, during deep sleep, especially at the beginning of deep sleep, for example, within the first few seconds after the onset of the 5-signal component.

[0029] The determination of the 5-wave main wave, in particular the 5-wave frequency, 5-wave amplitude, and / or 5-wave phase, is performed, for example, using FFT analysis and / or PLL algorithms. According to a further advantageous configuration, the control and evaluation unit is designed to influence the patient via transcranial alternating current stimulation, whereby the stimulation frequency, stimulation amplitude, and / or stimulation phase correspond to the 5-wave frequency, 5-wave amplitude, and / or 5-wave phase. This enables particularly efficient transcranial alternating current stimulation tailored to the patient. In particular, the stimulation is optimally adapted to the patient's endogenous 5-wave main wave. This ensures effective and safe influencing and, in particular, support of the deep sleep phase.

[0030] According to a further advantageous embodiment, the control and evaluation unit is designed to initiate transcranial alternating current stimulation in phase synchrony with the 5-phase, preferably at essentially 0° of the 5-phase. This enables particularly efficient stimulation of the essentially synchronous 5-phase main wave, especially when the stimulation frequency is simultaneously adapted to the 5-phase frequency. Particularly preferably, the transcranial alternating current stimulation begins at essentially 0° of the 5-phase, i.e., at the zero crossing of the rising edge of the 5-phase main wave. This means, in particular, that the transcranial alternating current stimulation is initiated between a phase angle of the 5-phase of -10° to 10°, particularly from -5° to 5°, particularly from -1° to 1°, and preferably at exactly 0°.

[0031] Preferably, the stimulation frequency, stimulation amplitude, and stimulation phase correspond to the 5-frequency, 5-amplitude, and 5-phase, respectively. Transcranial alternating current stimulation can, in particular, be synchronized with the 5-main wave. According to a further advantageous embodiment, the control and evaluation unit is designed to alternately perform a stimulation interval, during which transcranial alternating current stimulation takes place, and a measurement interval, during which no transcranial alternating current stimulation takes place, during a detected deep sleep phase. It has been recognized that EEG measurements can be prevented or made more difficult during transcranial alternating current stimulation. By providing these measurement intervals, artifact-free determination of the 5-signal component, and especially the 5-main wave, as well as its properties, can be ensured.The measurement interval thus makes it possible, in particular, to check the effects of the transcranial AC stimulation of the immediately preceding stimulation interval. This allows, in particular, flexible adaptation of the transcranial AC stimulation to possible changes in the EEG signal. The control and evaluation unit enables closed-loop regulation of the transcranial AC stimulation. Preferably, the measurement interval can also be used to adapt other types of stimulation, especially acoustic stimulation.

[0032] Stimulation and measurement intervals are preferably performed alternately over the entire duration of the deep sleep phase. This allows for the verification of whether the deep sleep phase is actually occurring during the measurement intervals.

[0033] The stimulation intervals and measurement intervals can have different or the same stimulation and measurement durations, respectively. The stimulation duration and / or measurement duration can, for example, be between 1 s and 30 s, particularly between 5 s and 30 s. As mentioned above, transcranial alternating current stimulation is preferably combined with acoustic stimulation. For example, transcranial alternating current stimulation and acoustic stimulation can be coupled. The acoustic stimulation can preferably be performed during one or more stimulation intervals. It is also possible to perform acoustic stimulation during the measurement intervals. The acoustic stimulation does not affect EEG measurements.

[0034] It is particularly advantageous to be able to adjust the acoustic stimulation, especially its timing, for example relative to transcranial stimulation, based on measurements during one or more measurement intervals.

[0035] 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 5-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.

[0036] The acoustic stimuli signal can occur, for example, on one or more of the rising edges of the 5-wave main wave during a stimulation interval. For instance, the acoustic stimuli signal can occur on the first rising edge of the stimulation interval or on several, in particular all, rising edges. Additionally or alternatively, it is also possible for the acoustic stimuli signal to occur on rising edges of the 5-wave main wave during one or more measurement intervals.

[0037] According to a further advantageous embodiment, the control and evaluation unit is designed to generate the acoustic stimulation signal for a fraction of a period of the 5-signal component, in particular the 5-main wave, at a 5-phase between 0° and 90°, especially between 45° and 80°. For example, the acoustic stimulation signal can be pink noise, particularly with a duration of approximately 50 ms. The acoustic stimulation signal can, in particular, be an acoustic pulse. Acoustic stimulation at a 5-phase between 0° and 90°, especially between 45° and 80°, has proven particularly suitable, especially in combination with transcranial alternating current stimulation.

[0038] 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.

[0039] 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 sequence of tones can, in particular, be a relaxation melody or a relaxation 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.

[0040] 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 transition between sleep stages. With a stimulus signal that is below the arousal threshold but at least as loud as the hearing threshold, no awakening 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.

[0041] 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 stages.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.

[0042] 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.

[0043] 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.

[0044] 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 interference 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 interference signal in this example lie between 80 Hz and 320 Hz. The signal amplitudes of the feedback acoustic interference signal can be determined, in particular, analogously from those of the acquired EEG measurement signal. According to a further advantageous embodiment, the control and evaluation unit is designed to determine different sleep stages of the patient in real time and, in particular, with sleep stage accuracy.This allows for the immediate implementation of appropriate sleep modification measures via the sleep modification 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 (NI, N2), the deep sleep phase (N3), and the wake phase (e.g., WASO (Wake after Sleep Onset)). The sleep stages are recorded primarily using FFT (Fast Fourier Transform) analysis of the at least one measurement signal and / or pattern recognition within that signal. Pattern recognition can specifically check whether an EEG measurement signal contains signal regions exhibiting the temporal signal patterns typical of sleep spindles and / or K-complexes, and indicating a light sleep phase (NI, N2).A REM sleep phase is characterized in particular by rapid, opposing eye movements, which can be preferably detected using recorded EOG measurement signals.

[0045] 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. This can, in particular, prolong and / or increase the intensity of deep sleep, which can be beneficial, for example, in the treatment of early-stage dementia (Alzheimer's disease).According to a further advantageous embodiment, the control and evaluation unit is designed to detect a REM sleep phase, in particular the beginning of a REM sleep phase, and to subject the patient to an acoustic influence signal by means of the sleep influencing unit in such a way 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 influence 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, is particularly beneficial 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.

[0046] According to another advantageous embodiment, the control and evaluation unit has an electrical energy storage device whose storage capacity is dimensioned for operation of the device for at least five nights. The device can therefore be operated for a sufficiently long period without the need for recharging or replacing the energy storage device or any other service action. This simplifies handling by the patient.

[0047] 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.

[0048] 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.

[0049] According to a further advantageous embodiment, the control and evaluation unit is designed to record and store, preferably in real time, a signal—particularly acoustic or tactile—generated by the sleep modification unit and delivered to the patient. This facilitates verification of the modification measure and, in particular, adjustment of the signal if the desired effect has not occurred.

[0050] 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:

[0051] Fig. 1 shows a block diagram of an exemplary embodiment of a

[0052] Sleep modification device with a sensor unit, a sleep modification unit, and a control and evaluation unit.

[0053] Fig. 2 shows a schematic partial representation of an embodiment of a sleep induction 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 the sleep induction unit and a preprocessing unit as part of the control and evaluation unit.

[0054] Figs. 3 to 5 show exemplary embodiments of frequency responses of the acoustic influencing signals in the form of various noise signals supplied to the patient by the sleep influencing unit according to Fig. 1 or 2.

[0055] Fig. 6 shows an EEG measurement signal recorded by the sensor unit according to Fig. 1 or 2 with marked times for the exposure of the patient to acoustic influence signals.

[0056] Figures 7A to 7C show a schematic partial representation of another embodiment of a sleep induction device according to Figure 1 in front, side and rear views, with measuring electrodes attached to the head of a patient for recording electrophysiological measurement signals as part of the sensor unit, headphones as a sleep induction unit, electrodes for transcranial alternating current stimulation and a preprocessing unit as part of the control and evaluation unit.

[0057] Fig. 8 shows a schematic flowchart for a method for analyzing and influencing a patient's sleep, in particular with the sleep-influencing device according to Fig. 7 A to 7C.

[0058] Fig. 9 schematically shows a diagram of the dominant frequency component of a 5-signal component of an EEG measurement signal and the stimulation adapted to it using transcranial alternating current and acoustic stimulation in stimulation intervals,

[0059] Figs. 10 and 11 schematically show variants of the stimulation adapted to the dominant frequency component of the 5-signal component according to Fig. 9, and Figs. 12A to 12C show a schematic partial representation of a further embodiment of a sleep influencing device according to Fig. 1 in front, side and rear views with measuring electrodes attached to the head of a patient for recording electrophysiological measurement signals as part of the sensor unit, headphones as a sleep influencing unit, electrodes for transcranial alternating current stimulation and a preprocessing unit as part of the control and evaluation unit.

[0060] Corresponding parts are provided with the same reference numerals in Figures 1 to 12. Details of the embodiments described in more detail below can also constitute an invention in themselves or be part of an invention.

[0061] 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.

[0062] The sensor unit 2 contains several sensors 5, 6, and 7 designed to detect measurement signals related to the sleep behavior of a patient 8. The sensors 5 are designed to detect electrophysiological measurement signals and include several measuring electrodes 9, 10, 11, and 12, which are to be placed on the scalp of the patient 8. As shown in Fig. 2, measuring electrode 9, which is preferably a ground electrode, is to be placed behind one ear of the patient 8. Measuring electrode 10 is to be placed to the right of the eyes, and measuring electrode 11 is to be placed opposite it, to the left of the eyes. The central measuring electrode 12 is to be placed, preferably, in the center of the forehead. The 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 currents; 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. Furthermore, the sensor unit contains two additional 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.

[0063] 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 particularly bidirectional. As shown in 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 other measuring electrodes 9, 10, and 11.

[0064] The sleep modification unit 3 is designed to apply a modification signal 18 to the patient 8. This modification signal 18 can be acoustic, tactile, or delivered via transcranial alternating current stimulation. Modification via multiple methods is also possible, specifically both acoustic and tactile, or both acoustic and transcranial alternating current stimulation. For delivering an acoustic modification signal 18, the sleep modification unit 3 includes headphones 19; for delivering a tactile modification signal 18, a vibrating wristband 20; and stimulation electrodes 30 for transcranial alternating current stimulation. There are embodiments in which the sleep modification unit 3 consists solely of the headphones 19, the vibrating wristband 20, or the stimulation electrodes 30.Combinations of headphones 19 and vibration armband 20, headphones 19 and stimulation electrodes 30 or vibration armband 20 and stimulation electrodes 30 are also possible.

[0065] In the embodiment shown in Fig. 2, the sleep induction unit 3 is implemented by the headphones 19. A unidirectional or bidirectional communication link 21 exists between the sleep induction 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.

[0066] Figure 2 shows the headphones as in-ear headphones, for example. Other embodiments may use bone conduction speakers or over-the-ear headphones.

[0067] Patient 8 interacts with the various units of the sleep influencing 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 influencing unit 3 and patient 8 is also, in particular, unidirectional. As already described, it is determined by the influencing signal 18, by means of which patient 8 is subjected to the sleep influencing 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.

[0068] 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.

[0069] 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.

[0070] The sleep-inducing device 1 has various applications for influencing the sleep state of patient 8.

[0071] In the first application scenario, patient 8 is still awake. In this case, the sleep-inducing device 1 supports the patient's sleep-falling behavior, for example, by presenting patient 8 with the influencing signal 18 in the form of a relaxation melody or a relaxation narrative. Alternatively, the influencing 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 influencing signal 18. The influencing signal 18 then represents a feedback signal that also serves to relax patient 8.

[0072] 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. 4 over the human-audible frequency range from 20 Hz to 20 kHz with logarithmic frequency scaling. The amplitude orThe volume of the noise signal in the form of pink noise 24 decreases with frequency f at 1 / f, specifically at 20 dB / decade. Figures 3 and 5 show other possible acoustic noise signals that can also be supplied to the patient 8 via the sleep induction unit 3 as an induction signal 18. The noise signal shown in Figure 3 is white noise 25, in which the signal amplitude or volume remains essentially constant over the entire frequency range. The amplitude or volume of the brown noise 26 shown in Figure 5 decreases more sharply with frequency f than that of the pink noise 24 shown in Figure 4, namely at 1 / f. 2 , especially at 40 dB / decade.

[0073] Pink noise 24 is used in the application to support the deep sleep phase. It is particularly advantageous if the patient 8 is exposed to such an influencing signal 18 at the correct time. The best effect in supporting deep sleep is achieved when the influencing signal 18, in the form of pink noise 24, is supplied synchronously with the rising edge of a 5-signal component in the EEG measurement signal. These particularly effective time points 27, which are synchronous with the rising edge of the 5-signal component in the EEG measurement signal, are marked in the section of such an EEG measurement signal 28 shown in Fig. 6. The EEG measurement signal 28 is plotted against time t in the diagram according to Fig. 6. At each of the marked time points 27, the influencing signal 18, in the form of pink noise 24, is supplied to the patient 8 for a duration of approximately 50 ms.This results in very effective support for deep sleep.

[0074] 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 is continued, 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 modification device 1 is an effective measure in the treatment of depression.

[0075] Figures 7A to 7C show a further embodiment of a sleep-inhibiting device as a schematic partial representation. The components of the sleep-inhibiting device, arranged on the head of patient 8, are shown. Figures 7A to 7C show a front, side, and rear view of patient 8 with the components of the sleep-inhibiting device arranged on the head.

[0076] The sleep modification device according to Figures 7A to 7C comprises – as already described with reference to Figure 2 – the preprocessing unit 14, headphones 19, and the measuring electrodes 9 to 12. The headphones 19 can, for example, be arranged bilaterally. These can preferably be over-ear headphones or bone conduction speakers. It is also possible to provide a headphone for only one ear of the patient 8.

[0077] The sleep-inhibiting device also includes stimulation electrodes 30 for transcranial alternating current stimulation. The stimulation electrodes 30 comprise two electrodes 31 and 32 located anteriorly in the forehead region and two stimulation electrodes 33 and 34 located posteriorly. The stimulation electrodes 31 and 32 on the frontal side and the posterior stimulation electrodes 33 and 34 alternately serve as current sources and current sinks for a stimulation current for transcranial alternating current stimulation. The stimulation electrodes 31 and 32 and the posterior electrodes 33 and 34 are preferably arranged symmetrically to the median sagittal plane of the patient's head 8. The stimulation electrodes 31, 32, 33, 34 are advantageously positioned such that the stimulation current flows through cortical areas that are particularly relevant for the deep sleep phase, especially with regard to 5-wave activity.The stimulation current flows primarily through the prefrontal cortex, the parietal / occipital cortex, and other subcortical regions. The arrangement of the stimulation electrodes 30 takes advantage of the biophysical properties of the human head, particularly the higher conductivity of the cerebrospinal fluid (CSF) and the scalp (-0.43 S / m to -1.79 S / m) compared to the skull (-0.01 S / m).

[0078] Figures 7A to 7C also schematically show a carrier 35 for at least some, preferably all, of the aforementioned components, in particular for the preprocessing unit 14, the measuring electrodes 9, 10, 11, 12, the stimulation electrodes 30 and / or the headphones 19. The carrier 35 can, for example, be in the form of a headband. The carrier 35 can, for example, include the headphones 19, in particular in the form of over-ear headphones and / or bone conduction speakers.

[0079] With reference to Figures 8 and 9, an exemplary method for promoting deep sleep activity is described, which can be carried out in particular with a sleep-inhibiting device designed according to Figures 7A to 7C. In a preparatory step 40, the sleep-inhibiting device is applied, in particular the individual components, for example electrodes, are positioned. This can preferably be done by applying a support element, in particular in the form of a headband.

[0080] In an EEG measurement step 41, an EEG measurement signal is recorded during the patient's sleep using suitable measuring electrodes, for example, measuring electrodes 9, 10, 11, 12. The recorded EEG measurement signal can, for example, correspond to the EEG measurement signal 28 in Fig. 6.

[0081] The recorded EEG measurement signal is evaluated using the control and evaluation unit 4, in particular using the preprocessing unit 14. In a sleep stage recognition step 42, the respective sleep stage of the patient 8 is determined, in particular with sleep stage accuracy.

[0082] In sleep stage comparison step 43, the detected sleep stage is compared with a target sleep stage, in this case, deep sleep (N3). If the patient is in a different sleep stage than deep sleep, sleep stage detection step 42 is repeated.

[0083] If the presence of a deep sleep phase (N3) is confirmed, a 5-signal analysis step 44 is performed. In the 5-signal analysis step 44, the presence of a 5-signal component is detected. In particular, a 5-main wave 45 of the patient is determined. A 5-main wave is understood here to be a patient-specific specific frequency component of the 5-signal component, in particular a dominant frequency component of the 5-signal component 8, a median frequency of the 5-signal component, and / or a center frequency of the 5-signal component. A dominant frequency component is, in particular, the frequency of the 5-signal component that has a major contribution to the 5-wave activity, for example, the frequency with the largest amplitude of the 5-signal component. The 5-main wave 45 has, in particular, a frequency between 0.5 Hz and 2.0 Hz. An exemplary 5-main wave 45 is plotted in Fig. 9 as a current I over time t as a dashed line.

[0084] The detection of the 5- signal component and in particular its analysis can be carried out, for example, by means of real-time spectral analysis (e.g., by means of FFT analysis), and / or by means of so-called phase-locked loop (PLL) algorithms.

[0085] In 5-signal analysis step 44, the amplitude, frequency, and phase of the 5-main wave 45 are determined in real time, particularly when the onset of deep sleep phase (N3) is detected. The frequency, amplitude, and phase of the 5-main wave 45 are also referred to as 5-frequency, 5-amplitude, and 5-phase, respectively.

[0086] It is also possible to determine a 5-wave main wave 45, in particular its individual, patient-dependent 5-frequency, in a preliminary calibration procedure, for example by measuring overnight. In the 5-signal analysis step, the existence of the 5-wave main wave 45, as well as its current 5-wave amplitude and 5-wave phase, can then be determined.

[0087] In a stimulation step 46, a transcranial alternating current stimulation 47 and an acoustic stimulation 48 are performed, which are coordinated in time.

[0088] The transcranial alternating current stimulation 47 is performed with a stimulation frequency, stimulation amplitude and / or stimulation phase that correspond to the 5-frequency, 5-amplitude and / or 5-phase respectively. In particular, phase-synchronous stimulation is performed, which essentially begins at a phase angle of 0° of the 5-phase of the 5-main wave 45.

[0089] Figure 9 shows the course of the stimulation current of the transcranial alternating current stimulation 47 over time t as a solid line. As can be seen in Figure 9, the stimulation current of the transcranial alternating current stimulation 47 follows the course of the 5-main wave 45, and in particular has a stimulation frequency, stimulation amplitude, and stimulation phase that correspond to the 5-frequency, 5-amplitude, and 5-phase, respectively. The transcranial alternating current stimulation 47 begins with a zero crossing of the 5-main wave (5-phase = 0°) and extends over several periods of the 5-main wave 45. In Figure 9, the course of the transcranial alternating current stimulation 47 and the course of the 5-main wave 45 are coincident in the time intervals in which the transcranial alternating current stimulation takes place (stimulation interval 49).

[0090] The stimulation amplitude of the transcranial alternating current stimulation 47 is in particular between 250 pA and 500 pA, in particular adapted to the current 5-amplitude of the 5-main wave 45.

[0091] The acoustic stimulation 48 begins with a time delay relative to the transcranial alternating current stimulation 47. The acoustic stimulation 48 occurs as an acoustic pulse during the rising edge of the 5-phase main wave 45, i.e., between 0° and 90° of the 5-phase. In the illustrated embodiment, the acoustic stimulation occurs as an acoustic pulse between 45° and 80° of the 5-phase. Depending on the 5-frequency, this corresponds to a time delay relative to the onset of the transcranial alternating current stimulation 47 of between 5 ms and 500 ms, particularly between 60 ms and 500 ms, and especially between 125 ms and 200 ms. In Fig. 9, the acoustic stimulation is schematically represented as a musical note symbol, which is assigned to the rising edge on which the acoustic stimulation occurs.

[0092] The acoustic stimulation is provided as an acoustic impulse, in particular the short-term playback of pink noise, for example for a period of about 50 ms.

[0093] Transcranial alternating current stimulation is performed in stimulation intervals 49 with a stimulation duration TS. Between two stimulation intervals 49, a measurement interval 50 with a measurement duration TM is performed. No stimulation, in particular no transcranial alternating current stimulation 47, is performed during the measurement interval 50. This enables artifact-free measurement of the EEG signal in the EEG measurement step 41, in particular artifact-free sleep stage detection in the sleep stage detection step 42 during the measurement interval 50. The sleep stage alignment step 43 and the 5-signal analysis step 44 can also be performed artifact-free during the measurement interval 50. The measurement interval 50 therefore enables a particularly precise determination of the 5 main wave 45 and, if necessary, adjustment of the transcranial alternating current stimulation 47 and / or acoustic stimulation 48 accordingly.The alternating stimulation intervals 49 and measurement intervals 50 enable a closed control loop for particularly precise stimulation using transcranial alternating current stimulation.

[0094] The stimulation duration TS of the stimulation intervals 49 can be the same or vary for different stimulation intervals 49. The stimulation duration TS can be the same or different from the measurement duration TM of the measurement intervals 50. In particular, 1 s < TS < 30 s, especially 5 s < TS < 30 s, and / or 1 s < TM < 30 s, especially 5 s < TM < 30 s.

[0095] The interaction between transcranial alternating current stimulation 47 and acoustic stimulation 48 is particularly advantageous. Their sequence first activates the cortical neurons and then the thalamocortical pathways, thus enhancing endogenous oscillations.

[0096] Transcranial alternating current stimulation adapted to the 5th main wave, 47, and in particular its phase-accurate onset at essentially 0° of the 5th phase, is especially precisely adapted to the respective cortical activity dynamics of the patient 8. Harmful interferences that could, for example, disrupt deep sleep are avoided. The efficiency and safety of sleep modification are improved, especially for elderly patients 8.

[0097] In the variant shown in Fig. 9, the acoustic stimulation takes place on the first rising edge of the 5 main wave 45 in a stimulation interval 49. Further variants are shown in Figs. 10 and 11.

[0098] In the variant shown in Fig. 10, the acoustic stimulation 48 takes place on several, in particular all, rising edges of the 5 main wave 45 during a stimulation interval 49.

[0099] In the variant shown in Fig. 11, acoustic stimulation also occurs on the rising edges of the 5-main wave 45 during the measurement interval 50. The acoustic stimulation does not interfere with the EEG measurement. In the variant shown in Fig. 11, acoustic stimulation occurs only on the first rising edge of the 5-main wave 45 of the respective stimulation interval 49. It is also possible to combine acoustic stimulation during the measurement interval 50 with further acoustic stimulation, in particular on all rising edges of the 5-main wave 45 in the stimulation intervals 49.

[0100] Figures 12A to 12C show a further embodiment of a sleep-inhibiting device in a schematic partial view, showing only the components located on the patient's head 8. The embodiment shown in Figures 12A to 12C largely corresponds to the embodiment shown in Figures 7A to 7C. It differs only in the arrangement of the stimulation electrodes 30. In the embodiment shown in Figures 12A to 12C, a front stimulation electrode 55, positioned centrally on the forehead, is combined with a posterior stimulation electrode 56 in the neck region. This arrangement of the stimulation electrodes 55 and 56 also provides the advantages discussed with regard to the stimulation electrodes 30 in Figures 7A to 7C.

[0101] Overall, the sleep-influence 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-influence device 1 can take place not in an unfamiliar environment, such as a clinic or sleep laboratory, but in the patient's 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-influence device 1. Furthermore, the complete independence of the sleep-influence 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.

Claims

Patent claims 1. Device for influencing the sleep of a patient (8) comprising a) a sensor unit (2) for recording at least one measurement signal (28) taken from the patient (8), b) a sleep influencing unit (3) for acting on the patient (8), and c) a control and evaluation unit (4), wherein d) the control and evaluation unit (4) dl) can be placed in the vicinity of the patient (8) and in his / her home environment, and d2) can be connected to the sensor unit (2) and the sleep influencing unit (3), and is designed to d3) evaluate the at least one measurement signal (28) and to recognize a current sleep state of the patient (8) from it, and d4) control the sleep influencing unit (3) depending on the recognized current sleep state and thus influence the current sleep state.

2. Device according to claim 1, characterized in that the sleep influencing unit (3) is designed to act on the patient (8) acoustically, tactilely and / or by means of transcranial alternating current stimulation, in particular both acoustically and tactilely or both acoustically and by means of transcranial alternating current stimulation.

3. Device according to claim 1 or 2, characterized in that the control and evaluation unit (4) is designed to act on the patient (8) by means of both acoustic stimulation and transcranial alternating current stimulation, wherein the acoustic stimulation and the transcranial alternating current stimulation are offset by a predetermined time interval.

4. Device according to one of the preceding claims, characterized in that the at least one measurement signal is an EEG measurement signal (28) and the control and evaluation unit (4) is designed to detect a 5-signal component, in particular a beginning of the 5-signal component, in the EEG measurement signal (28), especially in real time.

5. Device according to claim 4, characterized in that the control and evaluation unit (4) is designed to determine a 5-frequency, a 5-amplitude and / or a 5-phase of the 5-signal component in the EEG measurement signal (28).

6. Device according to claim 5, characterized in that the control and evaluation unit (4) is designed to act on the patient (8) by means of transcranial alternating current stimulation, wherein the stimulation frequency, stimulation amplitude and / or the stimulation phase correspond to the 5-frequency, 5-amplitude and / or 5-phase.

7. Device according to claim 6, characterized in that the control and evaluation unit (4) is designed to perform the transcranial To initiate alternating current stimulation in phase synchrony with the 5-phase, preferably at essentially 0° of the 5-phase.

8. Device according to one of claims 4 to 7, characterized in that the control and evaluation unit (4) is designed to alternately perform a stimulation interval, in which transcranial alternating current stimulation takes place, and a measurement interval, in which no transcranial alternating current stimulation takes place, during a detected deep sleep phase.

9. Device according to one of claims 5 to 8, characterized in 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 5-signal component in the EEG measurement signal (28) by means of the sleep influencing unit (3).

10. Device according to claim 9, characterized in that the control and evaluation unit (4) is designed to generate the acoustic influence signal (18) for a fraction of a period length of the 5- signal component at a 5-phase between 0° and 90°, in particular between 45° and 80°.

11. Device according to claim 9 or 10, characterized in 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.

12. Device according to one of the preceding claims, characterized in 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 pulse.

13. Device according to one of the preceding claims, characterized in 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), the volume of which is above or below an individual acoustic threshold of the patient (8).

14. Device according to one of the preceding claims, characterized in that the control and evaluation unit (4) is designed to determine at least one individual acoustic threshold of the patient (8).

15. Device according to one of the preceding claims, characterized in 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.

16. Device according to one of the preceding claims, characterized in 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).

17. Device according to one of the preceding claims, characterized in 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) by means of the sleep influencing unit (3) with an acoustic influencing signal (18) in the form of a tone sequence generated by the control and evaluation unit (4), 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).

18. Device according to one of the preceding claims, characterized in that the control and evaluation unit (4) is designed to determine different sleep stages of the patient (8) in real time.

19. Device according to one of the preceding claims, characterized in 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).

20. Device according to one of the preceding claims, characterized in 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.

21. Device according to one of the preceding claims, characterized in 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.

22. Device according to one of the preceding claims, characterized in that the control and evaluation unit (4) is designed to perform an initial calibration routine in order to determine the quality of the at least one measurement signal (28).

23. Device according to one of the preceding claims, characterized in 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).

24. Device according to one of the preceding claims, characterized in that the control and evaluation unit (4) is designed to preferably record and store in real time an influencing signal (18) generated by the sleep influencing unit (3) and supplied to the patient (8).

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