Electrical stimulation generating device and method for improving sleep disorder

Abstract

The invention relates to an electrical stimulation generating device for improving sleep disorders and a method for generating electrical stimulation pulses. Wherein the electrical stimulation generating device is used for generating a current, and the current is provided with an electrical stimulation pulse. Finally, the current with the electrical stimulation pulse is transmitted to the skin of an individual to achieve the effect of improving sleep disorders.

Description

Technical Field

[0001] The present invention relates to an electrical stimulation generating device and method for improving sleep disorders, and in particular to an electrical stimulation generating device and application method thereof that generates a low-frequency electrical stimulation signal and transmits it to a user's body for improving sleep disorders. Background Art

[0002] The main function of sleep is to repair the body's physical energy consumption during the day, restore the immune system, and organize emotional behavior and cognitive memory. Once you encounter abnormal sleep-related behaviors such as the inability to fall asleep normally or sleeping too long, it is called a sleep disorder. Insomnia is one of the most common sleep disorders. Sleep disorders may cause physical fatigue, immune system, endocrine system, or adverse changes in the psychological and mental aspects. Currently, drug therapy or behavioral therapy are more commonly used. Although drug therapy can quickly achieve the effect of falling asleep, it may have the side effect of drug addiction. Therefore, a non-drug, gentle and non-invasive treatment technology is extremely needed.

[0003] Furthermore, transcutaneous electrical nerve stimulators (TENS), also known as low-frequency therapy devices, are a well-known electrical stimulation technology. They primarily use an electrical stimulation generator to generate an electrical current signal, which is transmitted to the body via electrode patches attached to the skin for stimulation. Common uses include relieving muscle soreness and pain or training muscles through electrical stimulation signals. However, existing low-frequency devices on the market generally use biphasic electrical pulses, alternating between positive and negative phases. Some devices also use a medium-frequency interference signal that superimposes two frequencies. The output voltage generated by these devices is high volts (approximately 100V). Currently, low-frequency devices are rarely used to improve or treat sleep disorders. For example, electrical stimulation devices that use higher frequencies or higher voltages are not suitable for individuals with sleep disorders. Prolonged use of these devices can lead to muscle fatigue, further causing involuntary muscle tremors.

[0004] In view of this, in order to improve the problems of traditional technology and well-known electrical stimulation generation technology, such as unstable output voltage, inability to use high frequency for a long time, and safety when applied to individuals, the present invention provides an electrical stimulation generation device that can generate electrical stimulation signals. The low-frequency electrical stimulation signal can be transmitted to the individual through the skin via an electrode structure, which can effectively improve the user's sleep disorders (such as insomnia), and its low-frequency electrical stimulation signal will not cause muscle fatigue caused by common electrical stimulation. Summary of the Invention

[0005] The purpose of the present invention is to provide an electrical stimulation generating device for improving sleep disorders and a method for generating electrical stimulation signals, thereby applying electrical stimulation pulses to the human body that improve sleep disorders. The electrical stimulation generating device of the present invention generates a current that is transmitted to the human body through an electrode structure. The output voltage used can be applied to the human body. The human body is suitable for this voltage range and has relatively no use risks. Compared with the electrical stimulation signals generated by devices on the market, the electrical stimulation generating device is gentler and has no sensation. The electrical stimulation generating device can set different output frequencies through a program and can be selected and operated according to user needs. It is a non-invasive and easy-to-carry electrical stimulation generating device. Therefore, the electrical stimulation signal generated by the electrical stimulation generating device has the effect of improving insomnia.

[0006] To achieve the above-mentioned objectives, the present invention provides an electrical stimulation generating device for improving sleep disorders, the electrical stimulation generating device comprising a host, a signal generator, at least one signal transmission module, and at least one electrode structure. The signal generator is disposed in the host and is used to generate an electric current; one end of the signal transmission module is electrically connected to the signal generator; the electrode structure is electrically connected to the other end of the signal transmission module and has a contact surface for contacting the skin of an individual and transmitting the electric current to the individual; wherein the electric current generated by the signal generator has an electrical stimulation pulse, the frequency of the electrical stimulation pulse is 1 to 30 Hz, and includes a gradually increasing frequency group, a horizontal frequency group, or a gradually decreasing frequency group; the gradually increasing frequency group, the horizontal frequency group, and the gradually decreasing frequency group are each composed of a plurality of single-phase pulse groups, and the single-phase pulse group has a duty cycle of more than 60%.

[0007] In one embodiment of the present invention, the frequency range of the gradually increasing frequency group and the gradually decreasing frequency group of the electrical stimulation pulses of the electrical stimulation generating device is 5 to 30 Hz, and the frequency range of the horizontal frequency group is 4 to 8 Hz.

[0008] In one embodiment of the present invention, the gradually increasing frequency group of the electrical stimulation pulse of the electrical stimulation generating device has an output time of 350 to 470 seconds, the gradually decreasing frequency group has an output time of 170 to 250 seconds, and the horizontal frequency group has an output time of 1750 to 1850 seconds.

[0009] In one embodiment of the present invention, the gradually increasing frequency group of the electrical stimulation pulse of the electrical stimulation generating device includes a first gradually increasing frequency, a second gradually increasing frequency, and a third gradually increasing frequency in sequence; the horizontal frequency group includes a first horizontal frequency, a second horizontal frequency, a third horizontal frequency, a fourth horizontal frequency, and a fifth horizontal frequency in sequence; the gradually decreasing frequency group includes a first gradually decreasing frequency, a second gradually decreasing frequency, and a third gradually decreasing frequency in sequence.

[0010] In one embodiment of the present invention, the first gradually increasing frequency to the third gradually increasing frequency, the first horizontal frequency to the fifth horizontal frequency, and the first gradually decreasing frequency to the third gradually decreasing frequency of the electrical stimulation generating device have respective frequency ranges and respective output times.

[0011] In one embodiment of the present invention, the duty cycle of the monophasic pulse group of the electrical stimulation generating device is a 70% duty cycle or a 100% duty cycle.

[0012] In one embodiment of the present invention, each of the monophasic pulse groups of the electrical stimulation generating device is composed of a plurality of monophasic pulse waves with a duty cycle of 40% to 60%.

[0013] In one embodiment of the present invention, the waveform of the electrical stimulation pulse of the electrical stimulation generating device is a square wave, a sine wave, a triangle wave, or a sawtooth wave.

[0014] In one embodiment of the present invention, the signal transmission module is a signal transmission wire or a combination of a signal transmission wire and a magnetic buckle.

[0015] In one embodiment of the present invention, a potential difference range of the current of the electrical stimulation generating device is less than 10 Vpp.

[0016] In one embodiment of the present invention, the electrode structure of the electrical stimulation generating device contacts the abdominal skin of the individual.

[0017] The present invention also provides a method for generating the electrical stimulation pulses on the electrical stimulation generating device. The electrical stimulation pulses generated by this method can be sequentially transmitted from the signal generator to the individual via the electrode structure. After the electrical stimulation pulses act on the individual, they can effectively improve sleep disorders, compared to effects unattainable by traditional techniques.

[0018] To achieve the above objectives, the present invention provides an electrical stimulation generating device that can be used to improve sleep disorders and a method for generating the electrical stimulation pulses.

[0019] After referring to the accompanying drawings and the embodiments described below, those skilled in the art will understand other objectives of the present invention, as well as the technical means and implementation plans of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 This is a schematic diagram of a specific implementation of an electrical stimulation generating device according to an embodiment of the present invention;

[0021] Figure 2 is a schematic diagram of the system blocks within the electrical stimulation generating device of the present invention;

[0022] Figure 3is a schematic diagram of an electrical stimulation pulse in an embodiment of the present invention;

[0023] Figure 4 is a schematic diagram showing an electrical stimulation pulse displayed on an oscilloscope in an embodiment of the present invention;

[0024] Figure 5 is a schematic diagram of the potential difference generated by the electrical stimulation pulse in an embodiment of the present invention;

[0025] Figure 6 Schematic diagram of a single-phase pulse group formed by a single-phase pulse wave and a working period of the single-phase pulse group in an embodiment of the present invention;

[0026] Figure 7 is a schematic diagram of an electrical stimulation pulse for improving sleep disorders in an embodiment of the present invention;

[0027] Figure 8a This is a quantitative analysis result diagram of the severity of insomnia and the duration of in-bed use of an individual before and after using an electrical stimulation generating device in an embodiment of the present invention;

[0028] Figure 8b This is a diagram showing the quantitative analysis results of the Insomnia Severity Scale for individuals before and after using the electrical stimulation generating device according to an embodiment of the present invention;

[0029] Figure 8c This is a graph showing the assessment scores of the Insomnia Severity Scale for individuals before and after using the electrical stimulation device according to an embodiment of the present invention;

[0030] Figure 9 is a schematic diagram of a specific implementation of an electrical stimulation generating device according to another embodiment of the present invention;

[0031] Figure 10 is a schematic diagram of a specific implementation of an electrical stimulation generating device according to another embodiment of the present invention;

[0032] Figure 11 is an exploded view of an electrical stimulation generating device according to another embodiment of the present invention; and

[0033] Figure 12 This is an exploded view of an electrical stimulation generating device according to another embodiment of the present invention.

[0034] Description of Reference Numerals

[0035] 1000 electrical stimulation device

[0036] 1 host

[0037] 11 Interface Group

[0038] 111 Display Interface

[0039] 112 Operation Interface

[0040] 2 Signal Generator

[0041] 21 Control and drive unit

[0042] 22 Current output unit

[0043] 3 Signal transmission module

[0044] 4 Electrode structure. DETAILED DESCRIPTION

[0045] The present invention will be explained below through examples. The examples of the present invention are not intended to limit the present invention to any specific environment, application, or special method as described in the examples. Therefore, the description of the examples is only for the purpose of illustrating the present invention and is not intended to limit the present invention. It should be noted that in the following examples and drawings, elements that are not directly related to the present invention have been omitted and are not illustrated, and the dimensional relationships between the elements in the drawings are only for ease of understanding and are not intended to limit the actual proportions.

[0046] First, see Figures 1 to 2 , Figure 1 FIG. 1 is a schematic diagram of an electrical stimulation generating device 1000 according to an embodiment of the present invention. Figure 2 FIG. 1 is a schematic diagram of the system blocks within the electrical stimulation generating device 1000 of the present invention. Figure 1 As shown, the electrical stimulation generating device 1000 includes a host 1, a signal generator 2, two signal transmission modules 3, and two electrode structures 4. The signal generator 2 is disposed in the host 1, and the two electrode structures 4 are placed on the abdomen of a subject. The signal generator 2 can generate and transmit an electric current to the subject. It should be noted that in this embodiment, the electrical stimulation generating device 1000 uses two signal transmission modules 3 and two correspondingly connected electrode structures 4 as an example. This embodiment can be adjusted according to the usage scenario or needs, and is not limited to this embodiment.

[0047] In this embodiment, the host 1 may include an interface assembly 11, which is disposed on the surface of the host 1. The two ends of the signal transmission module 3 are respectively connected between the signal generator 2 and the electrode structure 4. Specifically, the interface assembly 11 may include a display interface 111 and an operation interface 112. The display interface 111 primarily provides the user with a display screen for operation adjustments or function operations, while the operation interface 112 primarily allows the user to select operation switches and pre-programmed command signals. It should be noted that in this embodiment, the display interface 111 and the operation interface 112 have independent functions. Considering the practicality and convenience of operating the electrical stimulation generating device 1000, they can also be combined into an interface that simultaneously performs display and operation functions, which is not limited here.

[0048] Next, the signal generator 2 is further described. Please refer to Figure 2 The signal generator 2 may include a control and drive unit 21 and a current output unit 22 for generating a current, wherein the generated current has an electrical stimulation pulse with a frequency of 1 to 30 Hz. The control and drive unit 21 may be triggered by a command signal generated by the user operating the operating interface 112 of the host 1, and then output a corresponding drive signal to control the current output unit 22, further causing the current output unit 22 to adjust the output of the electrical stimulation pulse and its duty cycle, frequency, and potential difference parameters pre-set by the program. It may also control the power on or off of the current output unit 22. Furthermore, the operating interface 112 may also transmit the selected parameter content and time information to be output via the control and drive unit 21 to the display interface 111, so that the user can confirm the current status of the device. It should be noted that the control and drive unit 21 may be a combination of a controller and a drive circuit, and the aforementioned control and drive unit 21 is illustrated as one. The combination of the control and drive units may be adjusted according to actual needs and is not limited here.

[0049] One end of the signal transmission module 3 is electrically connected to the signal generator 2, and the other end of the signal transmission module 3 is electrically connected to one side of the electrode structure 4. The other opposite side of the electrode structure 4 is used to contact the skin of the individual. The signal transmission module 3 is connected between the signal generator 2 and the electrode structure 4. When electrically connected, the signal generator 2 generates a current with an electrical stimulation pulse. Please refer to Figures 3 and 4 ,like Figure 3 The electrical stimulation pulse shown is a monophasic pulse wave with a 50% duty cycle, and Figure 4 The oscilloscope diagram shows a monophasic pulse wave with a 50% duty cycle. This 50% duty cycle indicates that the ratio of the monophasic pulse wave's on-time (time when an electrical signal is output) to its off-time (time when an electrical signal is not output) is 1:1. Specifically, a monophasic pulse wave is an electrical pulse outputted in a fixed positive phase. During the on-time period, at least 75% of the pulses in the monophasic waveform have a duty cycle of 50% ± 10%, enabling efficient and stable output signals from the electrical stimulation generating device 1000.

[0050] In this embodiment, if Figure 4 As shown, the schematic diagram of the electrical stimulation pulse displayed on the oscilloscope can show that the electrical stimulation pulse is a square wave output with a positive phase. It should be noted that the user can adjust the output of the controller and driving circuit of the control and driving unit 21 according to needs, and select other single waveforms with similar effects to the square wave, such as sine wave, triangle wave, or sawtooth wave, etc., which are not limited here.

[0051] Specifically, please see Figures 5 to 7 The potential difference generated by the electrical stimulation pulse is less than 10 Vpp. The potential difference used in the present invention is a voltage potential difference. Similarly, the potential difference used in the present invention can be commonly used in the technical field, including peak-to-peak voltage (Vpp), maximum voltage (Vmax), or root mean square voltage (Vrms). The potential difference is preferably less than 9.6 Vpp, and more preferably 4.8 to 9.6 Vpp. Compared to other common brands of electrical stimulation generating devices on the market, which have higher voltage outputs and less stable output amplitudes, the electrical stimulation generating device 1000 of the present invention can output a stable voltage potential difference within the aforementioned range, and provides the user with a voltage potential difference range suitable for application to the human body.

[0052] In this embodiment, if Figures 6 and 7 As shown, the electrical stimulation pulses include a gradually increasing frequency group, a horizontal frequency group, or a gradually decreasing frequency group; the gradually increasing frequency group, the horizontal frequency group, and the gradually decreasing frequency group are each composed of a plurality of single-phase pulse groups, and the duty cycle of the single-phase pulse group is greater than 60%. In this embodiment, the duty cycle of the single-phase pulse group is a 70% duty cycle or a 100% duty cycle. The 70% duty cycle means that the single-phase pulse group stably outputs power for 0.7 seconds and remains stationary for 0.3 seconds within 1 second in each output cycle. The duty cycle of the single-phase pulse group in another embodiment is a 100% duty cycle, which means that the single-phase pulse group stably outputs power continuously within the time. In detail, the frequency used in the present invention is an oscillation frequency generated by the signal generator 2. Similarly, the aforementioned oscillation frequency can also be replaced by a vibration frequency commonly used in the technical field. In this embodiment, the frequency range of the gradually increasing frequency group and the gradually decreasing frequency group is preferably 5 to 30 Hz, more preferably 8 to 28 Hz, and the frequency range of the horizontal frequency group is preferably 4 to 8 Hz, more preferably 5 to 7 Hz. The gradually increasing frequency group consists of a plurality of frequencies, each of which has an output time of 10 to 30 seconds. After a frequency is completed, the next frequency in the frequency group is executed, and the next output frequency is higher than the previous output frequency. The horizontal frequency group consists of a plurality of frequencies, each of which has an output time of 300 to 420 seconds. After a frequency is completed, the next frequency in the frequency group is executed. The gradually decreasing frequency group consists of a plurality of frequencies, each of which has an output time of 5 to 15 seconds. After a frequency is completed, the next output frequency is lower than the previous output frequency. Each of the aforementioned frequency groups has its own output time. For example, the gradually increasing frequency group has an output time of 350 to 470 seconds, the gradually decreasing frequency group has an output time of 170 to 250 seconds, and the horizontal frequency group has an output time of 1750 to 1850 seconds. In this embodiment, if Figure 7As shown, the electrical stimulation pulses generated by the electrical stimulation generating device 1000 are sequentially composed of a first gradually increasing frequency group, a second horizontal frequency group, and a third gradually decreasing frequency group. The duty cycle of each monophasic pulse wave is 50%, and the duty cycle of each monophasic pulse group is 100%. The first gradually increasing frequency group sequentially includes a first gradually increasing frequency, a second gradually increasing frequency, and a third gradually increasing frequency; the second horizontal frequency group sequentially includes a first horizontal frequency, a second horizontal frequency, a third horizontal frequency, a fourth horizontal frequency, and a fifth horizontal frequency; and the third gradually decreasing frequency group sequentially includes a first gradually decreasing frequency, a second gradually decreasing frequency, and a third gradually decreasing frequency. Furthermore, the first to third gradually increasing frequencies in the gradually increasing frequency group, the first to fifth horizontal frequencies in the horizontal frequency group, and the first to third gradually decreasing frequencies in the gradually decreasing frequency group have respective frequency ranges and respective output times. In detail, the gradually increasing frequency group includes, in sequence, a first gradually increasing frequency in the frequency range of 15 to 30 Hz, a second gradually increasing frequency in the frequency range of 10 to 20 Hz, and a third gradually increasing frequency in the frequency range of 5 to 15 Hz; the horizontal frequency group includes, in sequence, a first horizontal frequency in the frequency range of 6 to 8 Hz, a second horizontal frequency in the frequency range of 5 to 7 Hz, a third horizontal frequency in the frequency range of 4 to 6 Hz, a fourth horizontal frequency in the frequency range of 5 to 7 Hz, and a fifth horizontal frequency in the frequency range of 6 to 8 Hz; the gradually decreasing frequency group includes, in sequence, a first gradually decreasing frequency in the frequency range of 20 to 5 Hz, a second gradually decreasing frequency in the frequency range of 30 to 15 Hz, and a third gradually decreasing frequency in the frequency range of 30 to 25 Hz. Among them, the action time of the first gradually increasing frequency and the second gradually increasing frequency is 150 to 200 seconds, respectively, and the action time of the third gradually increasing frequency is 50 to 70 seconds; the action time of the first horizontal frequency, the second horizontal frequency, the third horizontal frequency, the fourth horizontal frequency, and the fifth horizontal frequency is 350 to 370 seconds, respectively; finally, the action time of the first gradually decreasing frequency and the second gradually decreasing frequency is 80 to 100 seconds, respectively, and the action time of the third gradually decreasing frequency is 10 to 50 seconds. The combination order of the gradually increasing frequency group, the horizontal frequency group, and the gradually decreasing frequency group, the frequencies used in the frequency range of each group, and the output time can be adjusted according to actual needs and are not limited here.

[0053] In this embodiment, the frequency range of the electrical stimulation pulse is preferably 1 to 30 Hz, more preferably 5 to 28 Hz. The frequency range used in the embodiments of the present invention is 5 to 7 Hz and 8 to 28 Hz. The frequency range can be adjusted according to actual needs and is not limited here.

[0054] In detail, the two signal transmission modules 3 included in the electrical stimulation generating device 1000 in this embodiment are two signal transmission wires for transmitting current, wherein the signal transmission module 3 connected to one end of the signal generator 2 includes providing corresponding positive electrodes and negative electrodes. At this time, the two signal transmission modules 3 connected to one end of the signal generator 2 can be combined and regarded as one signal transmission module 3. When the aforementioned signal transmission module 3 is ready to be used to connect the electrode structure 4 and to contact the biological body, it can be divided into one signal transmission module 3 for the positive electrode and one for the negative electrode (see Figure 1 ), the number of which can be adjusted according to actual needs and is not limited here.

[0055] In this embodiment, the electrode structure 4 is in the form of a sheet, cloth, or wearable device. This structure can be attached to or contacted with a living organism, and transmit the current generated by the signal generator 2 to the living organism. The present invention is not limited to this structure. Furthermore, in this embodiment, the electrode structure 4 has a contact surface, and the contact surface is located on the skin of the living organism. In this embodiment, the application site is preferably the abdominal skin. Unlike conventional electrical stimulation devices that are used near the head to stimulate related nerves, this embodiment primarily delivers electrical stimulation pulses to the individual's abdomen. This can reduce unnecessary stimulation to the brain and potential damage, and can also improve sleep disorders through the interaction of the electrical stimulation pulses with the living organism.

[0056] Please also refer to Figures 9 to 12In another embodiment of the present case, the signal transmission module 3 is a combination of a signal transmission wire and a magnetic buckle. Among them, the signal generator 2 of the electrical stimulation generating device 1000 is arranged in the host 1, and the signal transmission wire in the signal transmission module 3 is also arranged in the host 1 (not shown), one end of which is electrically connected to the signal generator 2, and the other end is connected to a pair of magnetic buckles (female) on the surface of the host 1, and the pair of magnetic buckles (female) are arranged on the host 1. When electrically connected, the current output by the signal generator 2 is connected to the pair of magnetic buckles (female) on the surface of the host 1 through the signal transmission wire for output. In other words, the signal transmission module 3 of the electrical stimulation generating device 1000 is a design of a signal transmission wire connected to a magnetic buckle, and the electrode structure 4 is a conductive carbon film combined with a hydrogel patch, and its number can be adjusted according to actual needs and is not limited here. In this embodiment, a magnetic buckle type hydrogel patch is used to connect the host 1 and the individual. The surface of the hydrogel patch is an insulating layer, and has a pair of magnetic buckles (male) corresponding to the pair of magnetic buckles (female). The pair of magnetic buckles (male) penetrate the insulating layer and directly connect to the conductive carbon film below. Below the conductive carbon film is a layer of conductive hydrogel, and the hydrogel patch is attached to the individual's skin through the hydrogel. The pair of magnetic buckles (female) on the host 1 will directly connect to the pair of magnetic buckles (male) on the patch with magnetic force and conduct electrical signals to the patch. The conductive carbon film evenly disperses the electrical signals conducted by the connected magnetic buckles, and then transmits them to the individual's epidermis through the hydrogel, such as Figure 9 and Figure 11 As shown. It should be noted that the hydrogel patches can be used in pairs connected to the host 1. The two hydrogel patches can be separate or connected to form a single structure via an insulating layer. The two magnetic clasps are adjacent to the conductive carbon film / hydrogel but do not contact each other. Therefore, the electrical stimulation generating device 1000 in this embodiment transmits current to the individual via wireless electrical signal transmission.

[0057] In another embodiment of the present invention, Figure 10 and Figure 12As shown, the signal transmission module 3 of the electrical stimulation generating device 1000 is also a combination of a signal transmission wire and a magnetic buckle. Its electrode structure 4 is two carbon film electrodes, the number of which can be adjusted according to actual needs and is not limited here. In this embodiment, a conductive belt is used to connect the host 1 and the individual. The conductive belt is made of fabric material, has a pair of magnetic buckles (male) on the outer surface, and contains a pair of carbon film electrodes on the inner surface for contacting the individual's skin. The magnetic buckles and the carbon film electrodes are connected by a signal transmission wire embedded in the belt fabric (not shown). The conductive belt has a plastic belt loop on one end and Velcro on the other end. When worn, the magnetic buckle faces outward and the carbon film electrodes face inward. It is wrapped around the waist of the person, and the end with the Velcro is passed through the belt loop on the other end. After adjusting the appropriate tightness, it is secured with the Velcro. In addition, the main unit 1 has a pair of female magnetic buckles that connect to the male magnetic buckles on the outside of the belt through magnetic force and transmit electrical signals. The electrical signals are transmitted to the individual carbon film electrodes via signal transmission wires within the belt fabric. The carbon film electrodes then contact the skin and transmit the electrical signals to the individual. Therefore, the electrical stimulation generating device 1000 in this embodiment transmits current to the individual by wirelessly transmitting electrical signals.

[0058] In this embodiment, the electrical stimulation generating device 1000 can be used to improve sleep disorders, including but not limited to insomnia, such as sleep abnormalities including narcolepsy, sleep apnea, rapid eye movement sleep behavior disorder, bruxism, sleepwalking and other parasomnias, sleep disorders related to mental, neurological and other health problems, and snoring.

[0059] In this embodiment, a method for applying the above-mentioned electrical stimulation generating device is also provided. The application method includes generating an electrical stimulation pulse that can improve sleep disorders.

[0060] Continuing from the above, the application method provides an electrical stimulation generating device 1000, which includes a host 1, a signal generator 2, two signal transmission modules 3, and two electrode structures 4. The signal generator 2 is disposed in the host 1, one end of the two signal transmission modules 3 is electrically connected to the signal generator 2, and the two electrode structures 4 are electrically connected to the other end of the signal transmission modules 3. The signal generator 2 then generates a current, which is transmitted to the individual through the electrode structures 4. The current generated by the signal generator 2 comprises an electrical stimulation pulse, the frequency of which is 1 to 30 Hz, and includes a gradually increasing frequency group, a horizontal frequency group, or a gradually decreasing frequency group. The gradually increasing frequency group, the horizontal frequency group, and the gradually decreasing frequency group are each composed of multiple single-phase pulse groups, each of which has a duty cycle of 60% or more. It should be noted that in this embodiment, two signal transmission modules 3 and two correspondingly connected electrode structures 4 are used as examples. Their quantity and type can be adjusted according to the usage scenarios or requirements of the electrical stimulation generating device 1000 in the above-mentioned different embodiments, and are not limited to this embodiment.

[0061] Example 1

[0062] [Improve sleep quality and sleep disorders]

[0063] First, the experiment was designed and executed, recruiting two groups of subjects, with 5 people in each group, and the male-female ratio ranged from 1:1 to 1:2. Each subject was given an electrical stimulation generating device 1000 of the present invention. The method of use was to attach the electrode structure 4 in the electrical stimulation generating device 1000 to the subject's abdomen and use it at bedtime for two consecutive weeks, and the usage time was recorded. The subject underwent a first sleep multi-physiological monitoring examination and basic body parameter measurement one day before using the electrical stimulation generating device for electrical stimulation treatment, and then underwent a second sleep physiological monitoring examination and basic body parameter measurement one day after the end of the two-week treatment period. The subjects were required to fill out the Pittsburgh Sleep Quality Index (PSQI) and the Insomnia Severity Index (ISI) before and after treatment. After two weeks of treatment, the improvement of the PSQI and ISI was compared.

[0064] The Pittsburgh Sleep Quality Inventory (PQSI) was developed by Dr. Buysse of the University of Pittsburgh in 1989. It is used to collect objective data on the subjects' sleep content in the past month. Appropriate self-assessment questions are selected according to the subjects' sleep conditions for assessment. The scale's assessment content includes 19 independent indicators, which can be divided into 7 combinations: subjective sleep quality, sleep latency, sleep time, habitual sleep efficiency, sleep disorders, use of sleeping pills and daytime dysfunction. These 7 combinations are scored between 0 and 3. Finally, the 7 combination scores are summed up, and the total score ranges from 0 to 21 points. A higher score indicates poorer sleep quality, and a lower score indicates healthier sleep quality.

[0065] The Insomnia Severity Index (ISI) is an internationally used assessment tool for identifying and categorizing the severity of insomnia, published by Dr. Charles M. Morin in 2011. It includes five indicators of sleep-related problems, divided into seven items, each scored between 0 and 4. The seven scores are then summed up to create a total score ranging from 0 to 28. Higher scores indicate more severe insomnia, while lower scores indicate better sleep quality.

[0066] The results of this electrical stimulation treatment on the subjects' insomnia severity scale can be found in Figures 8a to 8c After the subjects received the electrical stimulation pulses generated by the electrical stimulation generating device 1000 of the present invention for two weeks, experimental data were obtained and statistically analyzed using the t-value test.

[0067] The above experimental results show that the insomnia severity scale has been significantly improved after electrical stimulation treatment compared with that before treatment, such as Figure 8a and Figure 8b As shown in Figure 1, after the individual was treated with the electrical stimulation device 1000, the severity of insomnia was significantly reduced (P<0.01), and the reduction in insomnia severity was also accompanied by a reduction in the time the individual spent in bed. Figure 8c As shown, it can be found from the evaluation scores of the Insomnia Severity Scale that the scores of almost all subjects decreased significantly (P<0.01). The above experimental results show that after the subjects use the electrical stimulation generating device 1000 of the present invention, by generating a single-phase pulse group with at least 60% duty cycle formed by a single-phase pulse wave with 50% duty cycle, a frequency, and an electrical stimulation pulse of potential difference and transmitting it to the individual, the severity of the subjects' insomnia can be effectively reduced, and their sleep quality and sleep disorders can be greatly improved.

[0068] The above embodiments are intended only to illustrate the embodiments of the present invention and to illustrate the technical features of the present invention, and are not intended to limit the scope of protection of the present invention. Any modifications or equivalent arrangements that can be easily accomplished by those skilled in the art fall within the scope claimed by the present invention, and the scope of protection of the present invention shall be subject to the claims.

Claims

1. An electrical stimulation device for improving sleep disorders, comprising: One host; a signal generator, disposed in the host, for generating a current; at least one signal transmission module, one end of which is electrically connected to the signal generator; at least one electrode structure electrically connected to the other end of the signal transmission module and having a contact surface for contacting the skin of an individual and transmitting the current to the individual; The current generated by the signal generator has an electrical stimulation pulse, the frequency of the electrical stimulation pulse is 1 to 30 Hz, and includes a gradually increasing frequency group, a horizontal frequency group, or a gradually decreasing frequency group; the gradually increasing frequency group, the horizontal frequency group, and the gradually decreasing frequency group are each composed of multiple single-phase pulse groups, and the duty cycle of the single-phase pulse group is greater than 60%.

2. The electrical stimulation device for improving sleep disorders according to claim 1, wherein: The frequency ranges of the gradually increasing frequency group and the gradually decreasing frequency group are 5 to 30 Hz, and the frequency range of the horizontal frequency group is 4 to 8 Hz.

3. The electrical stimulation device for improving sleep disorders according to claim 1, wherein: The gradually increasing frequency group has an output time of 350 to 470 seconds, the gradually decreasing frequency group has an output time of 170 to 250 seconds, and the horizontal frequency group has an output time of 1750 to 1850 seconds.

4. The electrical stimulation device for improving sleep disorders according to claim 1, wherein: The gradually increasing frequency group includes a first gradually increasing frequency, a second gradually increasing frequency, and a third gradually increasing frequency in sequence; the horizontal frequency group includes a first horizontal frequency, a second horizontal frequency, a third horizontal frequency, a fourth horizontal frequency, and a fifth horizontal frequency in sequence; the gradually decreasing frequency group includes a first gradually decreasing frequency, a second gradually decreasing frequency, and a third gradually decreasing frequency in sequence.

5. The electrical stimulation generating device for improving sleep disorders according to claim 4, wherein: The first gradually-increasing frequency to the third gradually-increasing frequency, the first horizontal frequency to the fifth horizontal frequency, and the first gradually-decreasing frequency to the third gradually-decreasing frequency have respective frequency ranges and respective output times.

6. The electrical stimulation device for improving sleep disorders according to claim 1, wherein: The duty cycle of the single-phase pulse group is 70% duty cycle or 100% duty cycle.

7. The electrical stimulation device for improving sleep disorders according to claim 1, wherein: Each of the single-phase pulse groups is composed of a plurality of single-phase pulse waves with a duty cycle of 40% to 60%.

8. The electrical stimulation generating device for improving sleep disorders according to claim 1, wherein: The waveform of the electrical stimulation pulse is a square wave, a sine wave, a triangle wave, or a sawtooth wave.

9. The electrical stimulation device for improving sleep disorders according to claim 1, wherein: A potential difference range of the current is less than 10 Vpp.

10. The electrical stimulation generating device for improving sleep disorders according to claim 1, wherein: The signal transmission module is a signal transmission wire or a combination of a signal transmission wire and a magnetic buckle.

11. The electrical stimulation generating device for improving sleep disorders according to any one of claims 1 to 10, wherein: The electrode structure contacts the individual's abdominal skin.

12. A method applied to the electrical stimulation generating device for improving sleep disorders according to any one of claims 1 to 11.

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