Ear electroencephalogram acquisition sleep monitoring device based on conductive leather and personalized audio intervention method thereof

Abstract

The invention discloses an ear electroencephalogram acquisition sleep monitoring device based on conductive leather and a personalized audio intervention method of the ear electroencephalogram acquisition sleep monitoring device, and aims to solve the problems that existing sleep assisting equipment is poor in wearing comfort and inaccurate in monitoring, and an intervention scheme is lack of personalization. The device comprises preparation of a conductive leather electrode and integration of the conductive leather electrode, an earplug, a loudspeaker and other devices. According to the conductive leather electrode, a conductive polymer (such as poly (3, 4-ethylenedioxythiophene) and a derivative thereof) is combined with natural leather through an in-situ polymerization method to form a flexible electrode material with high biocompatibility. The electrode is combined with an earplug, a loudspeaker and other devices and can be stably attached to the ear canal, and high-signal-to-noise-ratio sleep physiological electric signal (such as myoelectricity, electroencephalogram or electrocardiosignals) collection is achieved. The sleep stage is identified through machine learning, and the loudspeaker module is controlled to play different types of sleep-aiding audios. The core lies in that the device can synchronously evaluate sleep physiological signal changes of a user under different audio stimulation, so that personalized sleep-aiding audios which are most effective for the individual are screened out, and an exclusive scheme library is established. The system has the advantages of being comfortable to wear, high in signal quality, wide in applicability and the like, and can be widely applied to the fields of health monitoring, human-computer interaction, medical diagnosis and the like.

Description

Technical Field

[0001] This invention relates to the field of wearable health monitoring technology, and in particular to an in-ear physiological electrical signal acquisition device based on conductive leather, and its application in the fields of sleep monitoring and audio intervention. Background Technology

[0002] In recent years, the rapid development of wearable technology has brought revolutionary opportunities to the healthcare field, particularly demonstrating enormous potential and market prospects in personalized health monitoring. Wearable medical devices can break through the time and space limitations of traditional medical models, providing users with convenient home care, customized health tracking, and continuous physiological data monitoring. These devices not only help users build personal health databases but also issue early warnings when potential health risks emerge, thereby changing people's perceptions and behaviors regarding health management and disease prevention.

[0003] For efficient and reliable health monitoring, the interface between wearable devices and human skin is crucial. Good skin contact and fit directly affect the quality of signal acquisition and the user's wearing experience. Traditional sensors based on rigid silicon materials are often large and hard, making it difficult to adapt to the complex surface contours of the human body, thus limiting their application in long-term, dynamic monitoring. Therefore, the research community has increasingly turned its attention to flexible electronics technology, developing novel sensors using flexible materials such as polymer elastomers. These materials are lightweight, soft, and stretchable, enabling conformal fit with the skin, significantly improving human-computer interaction performance and wearing comfort, and opening up broad application prospects for flexible wearable medical devices.

[0004] With the advancement of technology, people's pace of life is accelerating, and changes in stress and lifestyle leave many feeling exhausted. Maintaining healthy sleep is crucial for coping with these challenges. However, sleep problems are becoming increasingly serious globally. Research by the American Sleep Association indicates that almost everyone in the world experiences sleep issues to some degree. The prevalence of sleep problems not only affects individual quality of life but also has a profound impact on society. Common sleep disorders include insomnia, sleepwalking, hypersomnia, and sleep apnea. Effective sleep monitoring is key to solving sleep problems.

[0005] The ear canal offers unique advantages as a monitoring site for physiological electrical signals (such as electroencephalograms (EEGs) and electrocardiograms (ECGs). First, the ear canal's proximity to the cerebral cortex results in a short signal transmission path and low skin impedance, leading to less signal attenuation and a higher signal-to-noise ratio. This simplifies signal acquisition, allowing for clearer raw data without the need for complex amplification or filtering techniques. Second, the ear's relatively fixed anatomical position on the head prevents displacement due to limb movements, ensuring stable electrode contact with the skin, reducing signal fluctuations caused by poor contact, and improving the reliability of long-term monitoring. Furthermore, compared to traditional frontal EEG monitoring, using the ear canal as a signal acquisition fulcrum effectively isolates motion artifacts caused by head movements. These interfering signals are significantly attenuated by the time they reach the ear canal, resulting in a purer EEG signal that is more suitable for precise monitoring in dynamic environments.

[0006] Therefore, there is an urgent need to develop a new type of electrode material and integration solution that combines high signal-to-noise ratio, biocompatibility, and wearability comfort to promote the application of in-ear physiological monitoring devices in promoting sleep. Summary of the Invention

[0007] This invention aims to provide an ear-brain electrical signal acquisition and sleep monitoring device based on conductive leather and its personalized audio intervention method, to solve the problems of poor comfort and unstable signal quality in existing physiological electrical monitoring devices, and to address the technical problem of the lack of personalized physiological feedback in sleep intervention programs. Specific objectives include:

[0008] 1) Develop a flexible, highly conductive, and biocompatible conductive leather electrode material;

[0009] 2) Achieve high-quality acquisition of multimodal physiological signals (electromyography, electroencephalography, electrocardiography) within the ear canal;

[0010] 3) Achieve high-quality acquisition of EEG signals during sleep and identify sleep stages using machine learning algorithms;

[0011] 4) By playing audio to help people sleep, and combining it with sleep stage charts, the most effective personalized sleep aid audio for each individual is selected, and a dedicated solution library is established.

[0012] The method for preparing the electroencephalogram (EEG) electrodes of this invention involves in-situ generation of a conductive polymer within the collagen fiber network structure of leather, thereby imparting conductive functionality to the leather without sacrificing its original physical properties. The key steps are as follows:

[0013] 1) Monomer impregnation: Natural leather (such as cowhide, sheepskin, etc.) is pretreated in a solution of conductive monomers (such as 3,4-ethylenedioxythiophene, EDOT) to allow it to fully absorb the reactants;

[0014] 2) In-situ polymerization: The impregnated leather is transferred to a pre-cooled catalyst solution, which initiates the polymerization reaction of monomers in the fiber network inside the leather, forming a conductive path;

[0015] 3) Post-processing: Finally, the residue is removed and the material properties are stabilized by cleaning, ultrasonic treatment and gentle drying to obtain the finished conductive leather.

[0016] The assembly method of the ear-brain-electroencephalogram (EEG) sleep monitoring device is as follows:

[0017] 1) The conductive leather electrodes are integrated into the earplug surface through embedded and surface bonding methods, so that the flexible earplug structure can adapt to deformation when worn, ensuring stable contact between the electrodes and the skin of the ear canal, while ensuring stable collection of sleep ear EEG signals.

[0018] 2) The speaker is integrated inside the earbud, and the signal processing and transmission module is integrated at the end of the earbud to realize the processing and transmission function of the collected electroencephalogram (EEG) signals.

[0019] 3) The data is transmitted wirelessly to the host computer. The collected ear and brain signals are analyzed using machine learning algorithms to identify the sleep stage and select the most effective personalized sleep aid audio for the individual. Different types of sleep aid audio and volume are then played to help the user achieve the purpose of relaxation, stress relief and calming.

[0020] The beneficial effects of this invention are:

[0021] 1. This invention introduces a conductive leather material. Its conductivity originates from a conductive polymer (e.g., poly3,4-ethylenedioxythiophene and its derivatives). An innovative two-stage roller tanning process allows the conductive polymer to polymerize in situ on the leather fiber bundles. Utilizing the natural flexibility and biocompatibility of leather, it ensures a comfortable fit against the skin.

[0022] 2. The in-ear sleep optimization device based on conductive leather electrodes of the present invention has excellent signal acquisition performance, with a skin contact impedance between 10 and 1000 kΩ, and this impedance value remains almost constant at different current frequencies. This low impedance characteristic is superior to standard commercial electrodes, which helps to improve the efficiency of signal acquisition and transmission, reduce noise interference, and improve the accuracy of electrocardiogram signals.

[0023] 3. The earplugs of this invention can not only effectively collect sleep physiological electrical data, but also adjust the playback of sleep-aiding audio according to the wearer's real-time sleep status, thereby significantly improving sleep quality. At the same time, the device electrodes are lightweight, comfortable, and biocompatible, making them suitable for prolonged wear. Attached Figure Description

[0024] Figure 1This is a schematic diagram of the structure of an in-ear sleep optimization device according to an embodiment of the present invention.

[0025] Figure 2 Contact resistance data diagram of the in-ear sleep optimization device prepared according to an embodiment of the present invention;

[0026] Figure 3 Physiological electrosignal graphs collected by the in-ear sleep optimization device prepared according to embodiments of the present invention.

[0027] Figure 4 The in-ear sleep optimization device prepared according to the embodiments of the present invention collects sleep EEG time-frequency signals. Detailed Implementation

[0028] The present invention will be further described below with reference to embodiments. The following embodiments are only used to illustrate the performance of the present invention more clearly, and should not be limited to the embodiments described below.

[0029] Example:

[0030] I. Preparation of Conductive Leather

[0031] The electrode uses natural leather (such as sheepskin split leather) as a base. Conductive polymers are compounded in the natural collagen fiber network of the leather through in-situ polymerization, so that it has excellent conductivity while maintaining the inherent flexibility, breathability and biocompatibility of the leather.

[0032] The conductive leather electrode prepared by this process has the following key characteristics that make it suitable for this system:

[0033] 1) Physical properties: The electrode's self-resistance can be as low as 10-20 Ω / cm 2 It also has a micro-nano-scale fiber structure, which can adapt very well to the micro-contour of the ear canal skin, thereby establishing a stable low-impedance contact interface.

[0034] 2) Biocompatibility: It retains the characteristics of natural leather, is suitable for long-term skin contact, and is less likely to cause allergies or discomfort.

[0035] 3) Durability: The deep integration of the conductive polymer with the leather fiber network ensures that the electrodes maintain stable conductivity even after repeated wear and deformation. The conductive leather prepared by this method has an intrinsic impedance of 10–20 Ω / cm. 2 .

[0036] The prepared conductive leather material has the characteristics of micro- and nano-scale fibers and fiber clusters as well as multi-level deformation, which can adapt well to skin with various skin textures, thereby achieving a good contact effect and reducing the contact resistance of the human body interface.

[0037] II. Equipment Integration

[0038] This device employs two innovative electrode integration solutions: embedded and surface-fit. In the embedded design, conductive leather electrodes are precisely embedded within the foam matrix of the earplug. A special encapsulation process creates a smooth transition between the electrode surface and the earplug surface, ensuring a comfortable, unobtrusive feel during wear. The surface-fit solution uses medical-grade pressure-sensitive adhesive to directly bond the electrodes to the earplug surface. This design allows the electrodes to automatically adjust their contact angle according to the shape of the ear canal, ensuring stable mechanical properties and conductivity under ear canal temperature (32-37℃) and humidity (60-90% RH) conditions.

[0039] Therefore, the sleep monitoring device based on conductive leather electrodes of the present invention successfully solves the industry problem that traditional in-ear electrodes are difficult to balance in terms of comfort, stability and signal quality, and provides a reliable technical foundation for long-term and accurate sleep monitoring.

[0040] Equipment Structure Description

[0041] Please see Figure 1 The figure is a schematic diagram of the structure of an in-ear sleep optimization device according to a specific embodiment of the present invention. The main body of the device is composed of a foam earplug 1, which serves as the earplug support structure. Conductive leather 2 for collecting physiological electrical signals is attached to the surface of the foam earplug 1. A speaker 3 for playing sleep-aiding audio is provided inside the earplug.

[0042] The signal processing module transmits signals outward through a pathway formed by the metal clip 4 and the radio frequency cable 5. This pathway is primarily used to transmit the acquired electroencephalogram (EEG) signals. In addition, the device includes a reference electrode 6, which is a ring-shaped structure designed to fit snugly against the user's earlobe during wear, providing a stable reference for the collection of physiological electrical signals.

[0043] Therefore, the sleep monitoring device based on conductive leather electrodes of the present invention successfully solves the industry problem that traditional in-ear electrodes are difficult to balance in terms of comfort, stability and signal quality, and provides a reliable technical foundation for long-term and accurate sleep monitoring.

[0044] Signal collection and analysis

[0045] This in-ear sleep optimization system achieves personalized intervention through a complete closed-loop process: First, flexible conductive leather electrodes worn in the ear canal collect the user's electroencephalogram (EEG) and other physiological signals in real time; then, the built-in signal processing module amplifies, filters, and denoises the signals, and inputs the processed data into a machine learning model to accurately identify the user's sleep stage (such as light sleep, deep sleep, etc.); subsequently, the machine learning model is applied to identify the user's sleep stage, such as light sleep, deep sleep, and REM sleep. By correlating and analyzing the played audio with the user's sleep quality data over long-term use, the system can filter out the most effective personalized sleep aid audio and gradually build a dedicated solution library.

[0046] The above description is only a preferred embodiment of the present invention. It should be noted that those skilled in the art can make various modifications and improvements without departing from the inventive concept of the present invention, and these should also be considered within the scope of protection of the present invention.

Claims

1. A sleep monitoring device for ear-brain electrical activity acquisition based on conductive leather and its personalized audio intervention method, characterized in that, include: 1) An earplug support structure for wearing in the user's ear canal; 2) A flexible conductive leather electrode that is fitted or embedded in the earplug support structure, the electrode being composed of a natural leather substrate and a conductive polymer compounded by in-situ polymerization, for collecting physiological electrical signals in the ear canal; 3) A speaker module disposed within the earplug support structure. 4) Signal processing module; 5) Signal transmission interface; 6) Reference electrode; This signal processing module is connected to the flexible conductive leather electrode and the speaker module, and is configured to receive, process, and transmit the physiological electrical signals. The host computer processes and analyzes the physiological electrical signals to identify the user's sleep stage, and controls the speaker module to play corresponding sleep-aiding audio according to the sleep stage identified by the algorithm.

2. The device according to claim 1, characterized in that, The earplug support structure can be at least one of the following: in-ear headphones, noise-isolating earplugs, or specially designed ergonomically.

3. The device according to claim 1, characterized in that, The conductive polymer is selected from at least one of polythiophene, polypyrrole, polyaniline, or their derivatives.

4. The device according to claim 1 or 2, characterized in that, The natural leather base is at least one of cowhide, sheepskin, or pigskin, and its thickness ranges from 0.2 mm to 0.8 mm.

5. The device according to claim 1, characterized in that, The flexible conductive leather electrode has at least one of the following performance characteristics: a contact impedance of not more than 1000kΩ at a test frequency of 0.1Hz to 1kHz; and a tensile breaking rate of not more than 15%.

6. The device according to claim 1, characterized in that, The physiological electrical signals include at least one of the following: electroencephalogram (EEG) signals with a frequency range of 0.1-40 Hz, electromyography (EMG) signals with a frequency range of 10-500 Hz, electrocardiogram (ECG) signals with a frequency range of 0.05-100 Hz, or eye movement signals.

7. The device according to claim 1, characterized in that, The signal processing module is also configured to analyze the user's physiological electrical signal response during the playback of sleep-aid audio, and dynamically adjust or filter the types of sleep-aid audio to be played later based on the response results, so as to achieve personalized intervention.

8. The device according to claim 1, characterized in that, The device also includes a wireless communication module for connecting to a smart terminal device to enable real-time display of physiological signals, early warning of abnormal physiological states, or long-term health trend analysis on the smart terminal device.

9. A sleep monitoring device for collecting electroencephalogram (EEG) data and a personalized audio intervention method thereof, characterized in that, The method is performed by the device as described in any one of claims 1 to 8 and includes the following steps: acquiring the user's physiological electrical signals during sleep through the flexible conductive leather electrode; running a machine learning algorithm through the signal processing module to analyze the physiological electrical signals in real time and identify the user's sleep stage; and automatically playing corresponding sleep-aiding audio through the speaker module to intervene in the user's sleep according to the identified sleep stage.

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