Closed-loop sleep regulation and control head band device and method integrated with earlobe micro-electrical stimulation

Abstract

The invention discloses a closed-loop sleep regulation and control head band device integrated with earlobe micro-electrical stimulation, and relates to the technical field of sleep regulation and control head bands, the closed-loop sleep regulation and control head band device comprises a head band main body, connecting rods, a sponge belt and a connecting mechanism, massage instruments are symmetrically arranged on the outer wall of the head band main body, and the connecting rods are symmetrically and fixedly connected to the outer wall of the head band main body; the end part of the connecting rod is fixedly connected with an earlobe stimulator, the sponge belt is arranged outside the head band main body, and a connecting mechanism is arranged inside the head band main body. By means of the arrangement mode that the sponge belt, the winding rod, the connecting belt, the positioning assembly and the clamping assembly are matched, the length of the connecting belt can be adjusted through the positioning assembly, the tightness degree can be freely set according to the head circumference of a user, the tightening feeling is eliminated, and the winding rod and the clamping assembly ensure that the connecting belt is stably released and wound; it is ensured that the electroencephalogram collection electrode and the earlobe stimulator do not deviate from a preset part, and the accuracy of physiological signal collection and the effectiveness of stimulation intervention are guaranteed.

Description

Technical Field

[0001] This invention relates to the field of sleep regulation headband technology, and in particular to a closed-loop sleep regulation headband device and method integrating earlobe micro-electrical stimulation. Background Technology

[0002] The sleep regulation headband is a head-mounted device used for sleep monitoring and intervention. It integrates EEG acquisition and earlobe electrical stimulation functions, which can monitor sleep EEG waves in real time and dynamically output electrical stimulation according to the EEG state to achieve precise closed-loop regulation to improve sleep quality.

[0003] Existing sleep regulation headbands, in order to fit different patients, need to address the significant differences in individual head size and shape. Current designs generally use elastic bands to achieve a quick and tight fixation between the headband and the head. However, elastic bands exert continuous pressure on the head, which can easily cause discomfort after prolonged wear. In addition, the existing earlobe stimulators are separate from the head-mounted device, preventing the system from performing dynamic closed-loop control based on real-time sleep EEG status, causing inconvenience during use. Summary of the Invention

[0004] The purpose of this invention is to provide a closed-loop sleep regulation headband device and method integrating micro-electrical stimulation of the earlobe, so as to solve the problems mentioned in the background art.

[0005] To achieve the above objectives, the present invention provides the following technical solution: a closed-loop sleep regulation headband device integrating earlobe micro-electrical stimulation, comprising: The headband body has massagers symmetrically arranged on its outer wall; A connecting rod is symmetrically and fixedly connected to the outer wall of the headband body, and an earlobe stimulator is fixedly connected to the end of the connecting rod; A sponge band is provided on the outside of the headband body, and a connecting mechanism is provided inside the headband body for adjusting the position of the sponge band.

[0006] Preferably, the connecting mechanism includes: The headband body has a winding groove inside, and the winding rod is rotatably mounted inside the winding groove. A connecting strap, one end of which is fixedly connected to a sponge belt, and the other end of which is wrapped around the outside of a take-up rod; A positioning component, disposed inside the take-up bar, is used to adjust the length of the connecting belt; A clamping assembly, disposed inside the headband body, is used to secure the connecting strap.

[0007] Preferably, the positioning component includes: A rotating rod is fixedly connected to the top and bottom ends of a winding rod, and the rotating rod is rotatably inserted into the inner wall of the winding groove; An extrusion plate, wherein the rotating rod has an extrusion groove inside, and the extrusion plate is located inside the extrusion groove; A pull rod, which is fixedly inserted into the extrusion plate and rotatably inserted into the inner cavity of the winding rod; A pull plate, which is fixedly connected to the top of the pull rod; The positioning rod is fixedly connected to the bottom end of the pull plate at equal intervals, and the top end of the headband body is provided with positioning grooves that cooperate with the positioning rod at equal intervals; A first compression spring is sleeved on the outside of the pull rod.

[0008] Preferably, one end of the first compression spring is fixedly connected to the extrusion plate, and the other end of the first compression spring is fixedly connected to the top of the inner wall of the extrusion groove.

[0009] Preferably, the positioning component further includes: The extrusion plate is fixedly connected to the bottom end of the pull rod, and the headband body has a lifting groove inside that matches the displacement of the extrusion plate.

[0010] Preferably, the clamping assembly includes: The clamping plate has a through groove on the outer wall of the headband body for the connecting belt to pass through, and the clamping plate is located inside the through groove; The sliding plate has symmetrical sliding grooves on the inner wall of the through groove. The sliding plate is fixedly connected to the clamping plate and slidably inserted into the inner cavity of the sliding groove. The second compression spring is disposed inside the sliding groove.

[0011] Preferably, one end of the second compression spring is fixedly connected to the sliding plate, and the other end of the second compression spring is fixedly connected to the inner wall of the sliding groove.

[0012] Preferably, the clamping assembly further includes: An extrusion rod is slidably inserted into the inner cavity of a sliding plate; The extrusion block has symmetrically formed inclined grooves on the outer wall of the sliding plate. The extrusion block is fixedly connected to the outer wall of the extrusion rod, and the extrusion block is slidably inserted into the inner cavity of the inclined groove. A timing plate is fixedly connected to the bottom end of the extrusion rod, and the timing plate cooperates with the extrusion disc.

[0013] Preferably, rubber pads are fixedly connected to opposite sides of the clamping plate, and the outer wall of the rubber pads is provided with anti-slip texture.

[0014] This invention also provides a method for using a closed-loop sleep regulation headband device integrating earlobe micro-electrical stimulation, including the following specific steps: Step 1: The user adjusts the headband according to their head circumference using the connecting mechanism: Pulling up the pull plate disengages the positioning rod from the positioning groove on the headband body, releasing the locking state of the winding rod. Simultaneously, the pull plate drives the extrusion plate to rise via the pull rod. The extrusion plate presses against the synchronous plate, causing the extrusion rod to slide the extrusion block within the inclined groove. This drives the sliding plate to overcome the elastic force of the second compression spring, causing the clamping plate to loosen the connecting belt. At this point, the user can adjust the sponge belt to a suitable position so that the headband body fits comfortably against the head. After releasing the pull plate, the first compression spring drives the pull plate to reset via the extrusion plate, causing the positioning rod to re-engage in the corresponding positioning groove and lock the winding rod. At the same time, the extrusion plate descends to release the pressure on the synchronous plate. The second compression spring pushes the sliding plate to reset, allowing the clamping plate to securely clamp the connecting belt with the rubber pad. Step 2: The massager on the headband serves as the basis for EEG acquisition electrodes, working in conjunction with the reference electrode built into the earlobe stimulator, and performing electrode contact impedance detection: when the contact impedance between the earlobe electrode and the skin drops below 5kΩ, it is determined to be a good contact, and the next step of the EEG acquisition process is initiated; if the impedance is higher than 5kΩ, the user is prompted via the APP to adjust the wearing position until the contact quality is qualified. Step 3: Start EEG acquisition. The raw EEG signal is first filtered by 50Hz power frequency to remove electromagnetic interference caused by the power line, and then bandpass filtered by 0.5-100Hz to retain the effective EEG frequency band, filter out extremely low frequency drift and extremely high frequency electromyography noise, remove eye movement artifacts, and obtain the EEG signal. Step 4: Based on the preprocessed EEG signals, perform real-time sleep stage analysis: determine whether the user has entered the sleep stage by calculating the trend of the change in the proportion of delta wave energy, identify the N2 stage by identifying the spindle wave density, and monitor the coherence of gamma waves for subsequent evaluation of the effect of electrical stimulation intervention. The characteristic parameters of different sleep stages provide a basis for closed-loop stimulation control. Step 5: Based on the current sleep stage results, implement a dynamic stimulation strategy: In N1 stage, output 40Hz / 1mA / 500ms pulse stimulation, while monitoring whether the delta wave growth rate reaches more than 15% / minute to assess the sleep induction effect; in N2 stage, switch to 40Hz / 0.5mA continuous wave stimulation, maintaining the spindle wave density in the target range of 2-4 times / minute; in N3 stage, use a 2-minute stimulation followed by a 1-minute off method to maintain the slow wave amplitude above 75μV to ensure deep sleep quality. Step Six: After the light stimulation is initiated, the earlobe electrical stimulation is initiated 10ms later, so that the two work together within a 20ms synchronization window to form a closed-loop control, which improves sleep quality while ensuring wearing comfort.

[0015] The technical effects and advantages of this invention are as follows: (1) The present invention utilizes a combination of a sponge band, a winding rod, a connecting band, a positioning component, and a clamping component. The length of the connecting band can be adjusted by the positioning component, and the tightness can be freely set according to one's own head circumference. Unlike traditional elastic bands, it does not continuously apply rebound pressure to the head, thus eliminating the feeling of constriction. The winding rod and clamping component ensure stable release and winding of the connecting band, ensuring that the distance between the sponge band and the headband body remains stable and unchanged, ensuring that the EEG acquisition electrodes and the earlobe stimulator do not deviate from the predetermined position, thus ensuring the accuracy of physiological signal acquisition and the effectiveness of stimulation intervention. (2) The present invention utilizes the combination of the extrusion plate and the clamping component. When the positioning component releases the positioning of the winding rod, the extrusion plate can drive the clamping component to adjust its state, which allows the clamping component to release the connecting belt simultaneously, thereby facilitating subsequent winding and unwinding operations. After positioning, the clamping component returns to the clamping and fixing state, simplifying the operation steps, ensuring wearing stability, and preventing the connecting belt from accidentally slipping during use. Attached Figure Description

[0016] The accompanying drawings are provided to further illustrate the invention and form part of the specification. They are used together with the embodiments of the invention to explain the invention, but do not constitute a limitation thereof. In the drawings: Figure 1 This is a schematic diagram of the overall structure of the present invention; Figure 2 This is a schematic diagram of the internal structure of the connecting mechanism of the present invention from the front. Figure 3 For the present invention Figure 2 Enlarged structural diagram at point A in the middle; Figure 4 This is a schematic diagram of the internal structure of the side of the connecting mechanism of the present invention; Figure 5 For the present invention Figure 4 Enlarged structural diagram at point B; Figure 6 This is a schematic diagram of the structure of the clamping plate of the present invention; Figure 7 This is a flowchart of the ear electrode contact quality judgment and EEG signal processing of the present invention.

[0017] In the attached image: 1. Headband body; 2. Massager; 3. Connecting rod; 4. Ear lobe stimulator; 5. Sponge band; 6. Connecting mechanism; 61. Retracting rod; 62. Connecting belt; 63. Positioning assembly; 631. Rotating rod; 632. Extrusion plate; 633. Pull rod; 634. Pull plate; 635. Positioning rod; 636. First compression spring; 637. Extrusion disc; 64. Clamping assembly; 641. Clamping plate; 642. Sliding plate; 643. Second compression spring; 644. Extrusion rod; 645. Extrusion block; 646. Synchronizing plate; 7. Rubber pad. Detailed Implementation

[0018] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0019] This invention provides, for example Figure 1-7 The integrated earlobe micro-electrical stimulation closed-loop sleep regulation headband device shown includes a headband body 1, a connecting rod 3, an earlobe stimulator 4, a foam band 5, and a connecting mechanism 6. A massager 2 is symmetrically arranged on the outer wall of the headband body 1, which can be used to relax the head and facilitate the laying of the foundation for EEG acquisition electrodes. The connecting rod 3 is symmetrically fixedly connected to the outer wall of the headband body 1, and the earlobe stimulator 4 is fixedly connected to the end of the connecting rod 3, realizing the physical integration of the stimulation module and the head-mounted device and avoiding cable interference. The foam band 5 is located on the outside of the headband body 1, and the connecting mechanism 6 is located inside the headband body 1 to adjust the position of the foam band 5. The foam band 5 easily conforms to the head, ensuring comfort, and the size of the ring formed with the headband body 1 can be easily adjusted through the connecting mechanism 6 to fit different head circumferences.

[0020] The connecting mechanism 6 includes a winding rod 61, a connecting strap 62, a positioning component 63, and a clamping component 64. The headband body 1 has a winding groove inside, and the winding rod 61 is rotatably positioned inside the winding groove. One end of the connecting strap 62 is fixedly connected to the sponge band 5, and the other end of the connecting strap 62 is wrapped around the outside of the winding rod 61. The positioning component 63 is located inside the winding rod 61 and is used to adjust the length of the connecting strap 62. The clamping component 64 is located inside the headband body 1 and is used to fix the connecting strap 62. The length of the connecting strap 62 can be adjusted through the positioning component 63, allowing for free setting of tightness according to one's head circumference. Unlike traditional elastic bands, it no longer continuously applies rebound pressure to the head, eliminating the feeling of constriction. Furthermore, the winding rod 61 and the clamping component 64 ensure stable release and winding of the connecting strap 62, maintaining a stable distance between the sponge band 5 and the headband body 1. This ensures that the EEG acquisition electrodes and the earlobe stimulator 4 do not deviate from their predetermined positions, guaranteeing the accuracy of physiological signal acquisition and the effectiveness of stimulation intervention.

[0021] Furthermore, the positioning assembly 63 includes a rotating rod 631, an extrusion plate 632, a pull rod 633, a pull plate 634, a positioning rod 635, a first compression spring 636, and an extrusion disc 637. The rotating rod 631 is fixedly connected to the top and bottom ends of the take-up rod 61, and the rotating rod 631 is rotatably inserted into the inner wall of the take-up groove. An extrusion groove is formed inside the rotating rod 631, and the extrusion plate 632 is located inside the extrusion groove. The extrusion plate 632 has a rectangular cross-section and can only move vertically inside the extrusion groove, not rotate. Thus, the extrusion plate 632 can drive the rotating rod 631 to rotate, thereby enabling the take-up rod 61 to perform the operation of winding and unwinding the connecting belt 62. The pull rod 633 is fixedly inserted into the extrusion plate 632, and the pull rod 633 is rotatably inserted into the inner cavity of the take-up rod 61. 634 is fixedly connected to the top end of the pull rod 633; ​​the positioning rod 635 is fixedly connected to the bottom end of the pull plate 634 at equal intervals, and the top end of the headband body 1 is provided with positioning grooves that cooperate with the positioning rod 635 at equal intervals; the first compression spring 636 is sleeved on the outside of the pull rod 633, one end of the first compression spring 636 is fixedly connected to the extrusion plate 632, and the other end of the first compression spring 636 is fixedly connected to the top end of the inner wall of the extrusion groove. The first compression spring 636 always provides a stable elastic force to the pull rod 633 through the extrusion plate 632, so that the positioning rod 635 on the pull plate 634 can be stably engaged with the positioning groove, thereby stably fixing the winding rod 61 inside the headband body 1. The extrusion plate 637 is fixedly connected to the bottom end of the pull rod 633, and the inside of the headband body 1 is provided with a lifting groove that cooperates with the displacement of the extrusion plate 637.

[0022] Furthermore, the clamping assembly 64 includes a clamping plate 641, a sliding plate 642, a second compression spring 643, a pressing rod 644, a pressing block 645, and a synchronization plate 646. The outer wall of the headband body 1 has a through groove for the connecting belt 62 to pass through, and the clamping plate 641 is located inside the through groove. The inner wall of the through groove has symmetrical sliding grooves. The sliding plate 642 is fixedly connected to the clamping plate 641, and the sliding plate 642 is slidably inserted into the inner cavity of the sliding groove. The second compression spring 643 is disposed inside the sliding groove. One end of the second compression spring 643 is fixedly connected to the sliding plate 642, and the other end of the second compression spring 643 is fixedly connected to the inner wall of the sliding groove. The second compression spring 643 always provides a stable elastic force to the sliding plate 642, so that the clamping plate 641 can clamp the connecting belt 62, thereby ensuring that the connecting belt 62 wound on the winding rod 61 will not loosen, and also ensuring that the distance adjusted by the connecting belt 62 remains stable. The extrusion rod 644 is slidably inserted into the inner cavity of the sliding plate 642; the outer wall of the sliding plate 642 is symmetrically provided with inclined grooves, and the extrusion block 645 is fixedly connected to the outer wall of the extrusion rod 644, and the extrusion block 645 is slidably inserted into the inner cavity of the inclined groove; the synchronization plate 646 is fixedly connected to the bottom end of the extrusion rod 644, and the synchronization plate 646 cooperates with the extrusion disc 637. With the cooperation of the inclined groove, the sliding plate 642 can make the synchronization plate 646 on the extrusion rod 644 closely adhere to the extrusion through the extrusion block 645. The clamping plate 641 can stably clamp and fix the connecting belt 62 when the positioning component 63 is locked. When it is necessary to adjust the length of the connecting belt 62, the clamping plate 646 can be squeezed by the clamping plate 637, so that the clamping rod 644 can drive the clamping block 645 to move. The inclined groove allows the sliding plate 642 to overcome the elastic force of the second compression spring 643, so that the clamping plate 641 no longer clamps the connecting belt 62, which is convenient for adjustment and easy to use.

[0023] Rubber pads 7 are fixedly connected to each other on opposite sides of the clamping plate 641. The outer wall of the rubber pads 7 has anti-slip texture. The rubber pads 7 increase the coefficient of friction with the connecting strip 62, ensuring that the clamping is stable and reliable. At the same time, the rubber material has a certain elasticity, which can buffer the pressure during clamping, avoid hard damage to the connecting strip 62, and extend the service life.

[0024] How to use this invention: Step 1: The user adjusts the headband according to their head circumference using the connecting mechanism 6: Pulling up the pull plate 634 disengages the positioning rod 635 from the positioning groove on the headband body 1, releasing the locking state of the winding rod 61. Simultaneously, the pull plate 634, through the pull rod 633, drives the extrusion plate 637 to rise. The extrusion plate 637 presses against the synchronous plate 646, causing the extrusion rod 644 to slide the extrusion block 645 within the inclined groove. This drives the sliding plate 642 to overcome the elastic force of the second compression spring 643, causing the clamping plate 641 to loosen the connecting belt 62. At this time, the user can adjust the sponge band 5 to a suitable position so that the headband body 1 fits comfortably against the head. After releasing the pull plate 634, the first compression spring 636 drives the pull plate 634 to reset through the squeezing plate 632, so that the positioning rod 635 re-engages into the corresponding positioning groove to lock the winding rod 61. At the same time, the squeezing plate 637 descends to release the squeezing of the synchronization plate 646. The second compression spring 643 pushes the sliding plate 642 to reset, so that the clamping plate 641, together with the rubber pad 7, firmly clamps the connecting band 62, ensuring that the tightness of the fit is appropriate and that it will not slip during sleep. Step 2: The massager 2 on the headband body 1 serves as the basis for EEG acquisition electrodes, working in conjunction with the reference electrode built into the earlobe stimulator 4, and performing electrode contact impedance detection: when the contact impedance between the earlobe electrode and the skin drops below 5kΩ, it is determined to be a good contact, and the next step of the EEG acquisition process is initiated; if the impedance is higher than 5kΩ, the user is prompted through the APP to adjust the wearing position until the contact quality is qualified. Step 3: Start EEG acquisition. The raw EEG signal is first filtered by 50Hz power frequency to remove electromagnetic interference caused by the power line, and then bandpass filtered by 0.5-100Hz to retain the effective EEG frequency band, filter out extremely low frequency drift and extremely high frequency electromyography noise, remove eye movement artifacts, and obtain the EEG signal. Step 4: Based on the preprocessed EEG signals, perform real-time sleep stage analysis: determine whether the user has entered the sleep stage by calculating the trend of the change in the proportion of delta wave energy, identify the N2 stage by identifying the spindle wave density, and monitor the coherence of gamma waves for subsequent evaluation of the effect of electrical stimulation intervention. The characteristic parameters of different sleep stages provide a basis for closed-loop stimulation control. Step 5: Based on the current sleep stage results, implement a dynamic stimulation strategy: In N1 stage, output 40Hz / 1mA / 500ms pulse stimulation, while monitoring whether the delta wave growth rate reaches more than 15% / minute to assess the sleep induction effect; in N2 stage, switch to 40Hz / 0.5mA continuous wave stimulation, maintaining the spindle wave density in the target range of 2-4 times / minute; in N3 stage, use a 2-minute stimulation followed by a 1-minute off method to maintain the slow wave amplitude above 75μV to ensure deep sleep quality. Step Six: After the light stimulation is initiated, the earlobe electrical stimulation is initiated 10ms later, so that the two work together within a 20ms synchronization window to form a closed-loop control, which improves sleep quality while ensuring wearing comfort.

[0025] Step six involves dynamically adjusting the electrical stimulation intensity based on the difference between the target gamma energy and the actual gamma energy. The calculation formula is: stimulation intensity equals the base value plus 0.1 multiplied by the difference between the target gamma energy and the actual gamma energy, achieving precise closed-loop control. This effectively improves sleep quality while ensuring wearing comfort.

[0026] The above can also be used in the following application scenarios: Home sleep improvement scenarios: Targeting patients with chronic insomnia and sub-healthy individuals with poor sleep quality, the device analyzes the alpha / theta wave ratio through 10 minutes of baseline EEG monitoring during the pre-sleep preparation stage (21:00-22:00). The APP recommends personalized stimulation parameters based on historical data (default 40Hz, adjustable range 38-42Hz). During the sleep induction stage (22:00-23:30), when delta wave energy is detected to be >30%, it triggers bilateral 40Hz / 1mA microcurrent stimulation and simultaneously performs 40Hz prefrontal cortex micro-light stimulation to form cross-modal synergy. During the deep sleep maintenance stage (00:00-06:00), the stimulation intensity is dynamically adjusted (0.5-2mA) to maintain the N3 stage sleep ratio >20%, achieving intelligent sleep intervention throughout the entire cycle. Clinical adjunctive treatment scenarios: For patients with early-stage Alzheimer's disease and other individuals with sleep disorders and abnormal gamma oscillations, the device provides medical-grade precise parameter control, with the stimulation frequency precisely locked at 40.00±0.05Hz (controlled by a crystal oscillator), and the current intensity supports graded adjustment of 0.5 / 1.0 / 1.5 / 2.0mA with a doctor mode unlocking function. The collected data can be synchronized to the hospital's HIS system via the HL7 protocol, providing objective evidence for clinical diagnosis and treatment effect evaluation, and realizing a closed loop of sleep monitoring inside and outside the hospital. Special environment adaptation scenarios: For high-altitude hypoxic environments, the device adds a blood oxygen monitoring module. When SpO2 < 90%, it automatically reduces the stimulation intensity by 50% and adjusts the stimulation frequency to 38Hz to match the EEG characteristics under hypoxic conditions. For cross-time zone travel scenarios, the system automatically calculates the time phase advance based on the destination time difference (use 30 minutes in advance for every 1 hour difference) to help users quickly adjust their biological clock and effectively alleviate sleep disorders caused by jet lag.

[0027] During use, electrode contact impedance detection, multi-level filtering for noise reduction, and eye movement artifact removal ensure the purity and reliability of EEG signal acquisition, laying a data foundation for accurate sleep staging. Furthermore, based on real-time sleep staging results, stimulation parameters are dynamically adjusted (such as 40Hz / 1mA pulse stimulation, spindle wave density maintenance, and slow wave amplitude modulation), achieving closed-loop regulation throughout the entire cycle from sleep induction to deep sleep maintenance, thus improving the personalized intervention effect. Finally, through the temporal synergy of light and electrical stimulation (10ms delay, 20ms synchronization window) and multi-scenario adaptation (home insomnia improvement, clinical adjunctive treatment, and special environment response), cross-modal synergistic gain is formed, effectively improving the sleep quality of different groups while ensuring safety and comfort, and making it easy to use.

[0028] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A closed-loop sleep regulation headband device integrating earlobe micro-electrical stimulation, characterized in that, include: The headband body (1) has massagers (2) symmetrically arranged on the outer wall of the headband body (1). Connecting rod (3), the connecting rod (3) is symmetrically fixed to the outer wall of the headband body (1), and an earlobe stimulator (4) is fixedly connected to the end of the connecting rod (3). A sponge band (5) is provided on the outside of the headband body (1), and a connecting mechanism (6) is provided inside the headband body (1) for adjusting the position of the sponge band (5).

2. The closed-loop sleep regulation headband device integrating earlobe micro-electrical stimulation according to claim 1, characterized in that, The connecting mechanism (6) includes: The headband body (1) has a winding groove inside, and the winding rod (61) is rotatably disposed inside the winding groove. A connecting strip (62) is fixedly connected at one end to a sponge strip (5), and the other end of the connecting strip (62) is wrapped around the outside of the winding rod (61). Positioning component (63), which is disposed inside the winding rod (61) and is used to adjust the length of the connecting belt (62); A clamping assembly (64) is disposed inside the headband body (1) for fixing the connecting strap (62).

3. The closed-loop sleep regulation headband device integrating earlobe micro-electrical stimulation according to claim 2, characterized in that, The positioning component (63) includes: Rotating rod (631), the rotating rod (631) is fixedly connected to the top and bottom of the winding rod (61), and the rotating rod (631) is rotatably inserted into the inner wall of the winding groove; The extrusion plate (632) has an extrusion groove inside the rotating rod (631), and the extrusion plate (632) is located inside the extrusion groove; A pull rod (633) is fixedly inserted into the extrusion plate (632), and the pull rod (633) is rotatably inserted into the inner cavity of the winding rod (61); A pull plate (634) is fixedly connected to the top end of a pull rod (633); Positioning rod (635), the positioning rod (635) is fixedly connected to the bottom end of the pull plate (634) at equal intervals, and the top end of the headband body (1) is provided with positioning grooves that match the positioning rod (635) at equal intervals; A first compression spring (636) is sleeved on the outside of the pull rod (633).

4. The closed-loop sleep regulation headband device integrating earlobe micro-electrical stimulation according to claim 3, characterized in that, One end of the first compression spring (636) is fixedly connected to the extrusion plate (632), and the other end of the first compression spring (636) is fixedly connected to the top of the inner wall of the extrusion groove.

5. The closed-loop sleep regulation headband device integrating earlobe micro-electrical stimulation according to claim 3, characterized in that, The positioning component (63) further includes: The extrusion plate (637) is fixedly connected to the bottom end of the pull rod (633), and the headband body (1) is provided with a lifting groove that cooperates with the displacement of the extrusion plate (637).

6. The closed-loop sleep regulation headband device integrating earlobe micro-electrical stimulation according to claim 2, characterized in that, The clamping assembly (64) includes: The clamping plate (641) has a through groove on the outer wall of the headband body (1) for the connecting belt (62) to pass through, and the clamping plate (641) is located inside the through groove; The sliding plate (642) has symmetrical sliding grooves on the inner wall of the through groove. The sliding plate (642) is fixedly connected to the clamping plate (641), and the sliding plate (642) is slidably inserted into the inner cavity of the sliding groove. The second compression spring (643) is disposed inside the sliding groove.

7. The closed-loop sleep regulation headband device integrating earlobe micro-electrical stimulation according to claim 6, characterized in that, One end of the second compression spring (643) is fixedly connected to the sliding plate (642), and the other end of the second compression spring (643) is fixedly connected to the inner wall of the sliding groove.

8. The closed-loop sleep regulation headband device integrating earlobe micro-electrical stimulation according to claim 6, characterized in that, The clamping assembly (64) further includes: A compression rod (644) is slidably inserted into the inner cavity of a sliding plate (642); The extrusion block (645) has symmetrically provided inclined grooves on the outer wall of the sliding plate (642). The extrusion block (645) is fixedly connected to the outer wall of the extrusion rod (644). The extrusion block (645) is slidably inserted into the inner cavity of the inclined groove. Synchronous plate (646) is fixedly connected to the bottom end of extrusion rod (644), and the synchronous plate (646) cooperates with extrusion disc (637).

9. The closed-loop sleep regulation headband device integrating earlobe micro-electrical stimulation according to claim 6, characterized in that, Each of the clamping plates (641) is fixedly connected to a rubber pad (7) on the opposite side, and the outer wall of the rubber pad (7) is provided with anti-slip texture.

10. The method of using the integrated earlobe micro-electrical stimulation closed-loop sleep regulation headband device according to any one of claims 1-9, characterized in that, The specific usage steps are as follows: Step 1: The user adjusts the headband body (1) according to their head circumference using the connecting mechanism (6): Pull up the pull plate (634) to disengage the positioning rod (635) from the positioning groove on the headband body (1), releasing the locking state of the winding rod (61). At the same time, the pull plate (634) drives the extrusion plate (637) to rise through the pull rod (633). The extrusion plate (637) extrudes the synchronous plate (646), causing the extrusion rod (644) to drive the extrusion block (645) to slide in the inclined groove, thereby driving the sliding plate (642) to overcome the elastic force of the second compression spring (643) and drive the clamping plate (642) to move. 41) Loosen the connecting strap (62). At this time, the user can adjust the sponge strap (5) to a suitable position so that the headband body (1) fits comfortably against the head. After loosening the pull plate (634), the first compression spring (636) drives the pull plate (634) to reset through the squeezing plate (632), so that the positioning rod (635) is re-engaged into the corresponding positioning groove to lock the winding rod (61). At the same time, the squeezing plate (637) descends to release the squeezing of the synchronous plate (646). The second compression spring (643) pushes the sliding plate (642) to reset, so that the clamping plate (641) cooperates with the rubber pad (7) to firmly clamp the connecting strap (62). Step 2: The massager (2) on the headband body (1) serves as the basis for EEG acquisition electrodes. It works in conjunction with the reference electrode built into the earlobe stimulator (4) and performs electrode contact impedance detection: When the contact impedance between the earlobe electrode and the skin drops below 5kΩ, it is determined to be a good contact and proceeds to the next step of the EEG acquisition process. If the impedance is higher than 5kΩ, the user is prompted by the APP to adjust the wearing position until the contact quality is qualified. Step 3: Start EEG acquisition. The raw EEG signal is first filtered by 50Hz power frequency to remove electromagnetic interference caused by the power line, and then bandpass filtered by 0.5-100Hz to retain the effective EEG frequency band, filter out extremely low frequency drift and extremely high frequency electromyography noise, remove eye movement artifacts, and obtain the EEG signal. Step 4: Based on the preprocessed EEG signals, perform real-time sleep stage analysis: determine whether the user has entered the sleep stage by calculating the trend of the change in the proportion of delta wave energy, identify the N2 stage by identifying the spindle wave density, and monitor the coherence of gamma waves for subsequent evaluation of the effect of electrical stimulation intervention. The characteristic parameters of different sleep stages provide a basis for closed-loop stimulation control. Step 5: Based on the current sleep stage results, implement a dynamic stimulation strategy: In N1 stage, output 40Hz / 1mA / 500ms pulse stimulation, while monitoring whether the delta wave growth rate reaches more than 15% / minute to assess the sleep induction effect; in N2 stage, switch to 40Hz / 0.5mA continuous wave stimulation, maintaining the spindle wave density in the target range of 2-4 times / minute; in N3 stage, use a 2-minute stimulation followed by a 1-minute off method to maintain the slow wave amplitude above 75μV to ensure deep sleep quality. Step Six: After the light stimulation is initiated, the earlobe electrical stimulation is initiated 10ms later, so that the two work together within a 20ms synchronization window to form a closed-loop control, which improves sleep quality while ensuring wearing comfort.

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