Methods for olfactory training, nasal plug kits for use in olfactory training programs, and nasal plugs for use in olfactory training programs.

Abstract

This disclosure relates to a method for olfactory training and a computer program for use in the method for olfactory training, using a nasal plug adapted to be inserted into the nostrils of a human subject, wherein the nasal plug comprises a structural molding material and an aromatic substance, or a mixture of aromatic substances perceived as an odor, wherein the aromatic substance, or mixture of aromatic substances, is uniformly dispersed in the structural molding material. This disclosure further relates to a kit of nasal plugs for use in an olfactory training program and nasal plugs for use in an olfactory training program.

Description

Technical Field

[0001] The present disclosure relates to a method for olfactory training, a computer program for use in an olfactory training program, a kit of nose plugs for use in an olfactory training program, and a nose plug for use in an olfactory training program, as defined in the introductory part of the independent claims.

[0002] Background Art Olfactory loss can be either complete (anosmia), partial (hyposmia), or olfactory impairment (parosmia, characterized by the brain's inability to correctly identify the natural smell of an odor), and these are relatively common symptoms for many people. The causes of olfactory loss can be diverse, such as head trauma, infections, or medical or mechanical nasal obstruction. Psychological factors can also potentially have a significant impact on the experience of olfactory loss, at least in part. Furthermore, mental disorders such as depression are often seen in subjects who experience olfactory loss. Regardless of the cause and severity of the olfactory loss, there are training programs, so-called olfactory training programs, to partially or completely improve the sense of smell.

[0003] Hummel et al. ("Effects of olfactory training in patients with olfactory loss", Laryngoscope 119: March 2009, p496 - 499) discuss a training program for subjects with olfactory impairment. The subjects are exposed to various odors over time (12 weeks) in this program. In this study, it was revealed that while systematic short-term exposure to selected odors may improve olfactory sensitivity, the olfactory sensitivity of subjects who did not implement the training program did not change.

[0004] Pieniak et al. ("Olfactory training. Thirteen years of research reviewed," Neuroscience and Biobehavorial Reviews 141 (2022) 104853) reviewed the field of research on olfactory training.

[0005] Therefore, it is considered essential to implement olfactory training to improve or restore the loss of smell. Thus, it is important to identify training programs and associated equipment, as these facilitate such training and thereby increase the chances of successfully developing the subject's olfactory sensitivity.

[0006] However, current training programs have often been found to fail to produce the expected or desired results. Training programs used for specific subjects often lack scientific evidence, making it difficult to manage and follow up on subjects' ability to implement the program as planned. Often, this may be related to a lack of motivation and / or difficulties in practice among subjects undergoing the training program, and / or insufficient time to allow for systematic daily training. Furthermore, there are challenges regarding the efficiency and suitability of the methods and equipment currently in use.

[0007] Therefore, improved devices and training programs using such devices are needed to enhance the outcomes of olfactory training for subjects requiring olfactory training.

[0008] overview The purpose of this disclosure is to mitigate, alleviate or eliminate one or more of the above-mentioned defects and disadvantages of the prior art, and to solve at least the above-mentioned problems.

[0009] The inventors have surprisingly found that nasal plugs and / or multiple nasal plugs having substantially the same configuration as those described in International Publication 2011 / 162677 or International Publication 2018 / 206388 (both incorporated herein by reference) facilitate the training of olfactory sensitivity in subjects and patients requiring training of olfactory sensitivity by further comprising at least one aromatic substance, or a mixture of aromatic substances perceived as odors, i.e., substances or mixtures of substances that can have a specific odor which may be used for training the olfactory sense of a subject. In particular, the use of methods using nasal plugs for olfactory training results in a greater improvement in olfaction compared to the use of conventional methods, by improving the subject's adherence to the training program. This is mainly due to the ease of use and the fact that the device can be worn while performing daily tasks.

[0010] Therefore, according to the first aspect, a method for training the sense of smell, the method is a. Providing a subject with at least two or more nasal plugs fitted to be inserted into the nostrils of a human subject, wherein each nasal plug comprises a structural molding material and an aromatic substance, or a mixture of aromatic substances collectively perceived as an odor, wherein the aromatic substance, or mixture of aromatic substances, is uniformly dispersed in the structural molding material, and each of the two or more nasal plugs comprises a different aromatic substance, or a mixture of aromatic substances collectively perceived as an odor, b. The step of exposing at least one nostril of the subject to two or more nasal plugs, one at a time, in a predetermined order and for a predetermined period of time, c. Repeating the exposure step daily for a predetermined training period. The present invention provides a method for training the sense of smell, including the following.

[0011] This provides a training program utilizing nasal plugs containing (multiple types of) aromatic substances, thus facilitating training for subjects and patients with diverse needs for developing olfactory sensitivity. The primary objective is to enhance the recognition and sensitivity of various odors in individuals, particularly in the context of olfactory training and olfactory rehabilitation. In particular, the methods and apparatus disclosed herein are intended to be performed and used by subjects themselves, i.e., by the general public.

[0012] In another embodiment, the step of exposing the nostrils to the nasal plug includes the action of applying the nasal plug to the nostrils by having the subject insert the nasal plug at least partially into the nostrils. Preferably, the nasal plug is inserted about 15-20 mm into the lower part of the nasal cavity using the hand.

[0013] In a further embodiment, the step of exposing the nostrils to the nasal plug includes allowing the nasal plug to remain in the nostrils for at least about 5 minutes, more preferably about 10 minutes.

[0014] In some embodiments, the order in which subjects are exposed to aromatic substances, or mixtures of substances perceived as odors, is changed daily according to a predetermined plan.

[0015] This provides a systematic and diverse training program to enhance the subjects' sense of smell.

[0016] In some embodiments, at least two different nose plugs containing a mixture of different aromatic substances or substances perceived as odors are used in a predetermined order. In other embodiments, three, four, five, six, seven, eight, nine, ten, eleven, twelve, thirteen, fourteen, fifteen, sixteen, seventeen, eighteen, nineteen, twenty, twenty-one, twenty-two, twenty-two, twenty-three, twenty-four, twenty-five or more different nose plugs containing a mixture of different aromatic substances or substances perceived as odors are used in a predetermined order.

[0017] Therefore, sometimes improved development can be observed by changing the order of exposure to different aromatic substances or mixtures of substances perceived as odors.

[0018] In some embodiments, the predetermined sequence is such that on day 1, the subject is exposed to a mixture of at least four different aromatic substances or substances perceived as odors, and on day 2, the subject is exposed to a mixture of at least one other aromatic substance or substance perceived as odors compared to day 1. Preferably, the predetermined sequence is such that the subject is exposed to a mixture of at least four different aromatic substances or substances perceived as odors on each of the days.

[0019] In some embodiments, if the nasal plug used in the described training program has two parts intended for separate nostrils, each side may contain a different aromatic substance, resulting in each nostril being exposed to a mixture of different aromatic substances or substances perceived as odors. In other embodiments, if the nasal plug used in the described training program has two parts intended for separate nostrils, each side may contain a mixture of the same aromatic substance or substances at different concentrations, resulting in each nostril being exposed to a certain concentration of odor.

[0020] Therefore, by systematically modifying the training program on a daily basis, improved results can often be expected.

[0021] In some embodiments, the duration of the training program, i.e., the predetermined training period, is at least one month, preferably at least two to four months, during which the subject is exposed to the aromatic substance five days a week, and the subject takes two days off from training per week.

[0022] This provides a systematic program, designed to help motivate and prolong training, for the benefit of the subjects who need it.

[0023] According to some embodiments, the step of exposing the nostrils includes fully inserting most of the nasal plug, for example, the entire flexible member, into the nostrils such that only the support member remains outside the nostrils.

[0024] Thereby, a strong effect and / or an optimized effect of the fragrance is expected. Another advantage of fully or almost fully inserting most of the flexible member or the holding member into the nostrils is that only a very small part of the nasal plug protrudes from the nostrils, providing an individual visual experience, so that the user can perform daily tasks without seeing or being bothered by a bulky device. In particular, any embodiment of the nasal plug described herein provides for individual use.

[0025] According to some embodiments, the fragrance, or a mixture of substances perceived as smells, is selected from the group consisting of strawberry, vanilla, lemon, melon, rosemary, menthol, cherry, orange, peach, cola, lavender, clove, cocoa, coffee, citrus, carnation, rose, banana, apple, clove, and cinnamon.

[0026] According to some embodiments, the training is for the treatment of hyposmia, anosmia, and / or parosmia.

[0027] Thereby, the training program is intended for medical and non-medical conditions, thereby improving the olfactory sensitivity of subjects and patients with various needs.

[0028] According to some embodiments, hyposmia, anosmia, and / or parosmia are caused by the subject having had or having an infectious disease, a coronavirus infection, a sequela of a coronavirus infection, a head trauma and / or a nervous system injury, Parkinson's disease, Alzheimer's disease, a stroke, or depression.

[0029] Therefore, these are examples of situations where the olfactory training program of the present disclosure is useful when the sense of smell is partially or completely lost.

[0030] According to yet another aspect, a computer program for use in olfactory training according to the above-described aspect, which, when executed by at least one processor, causes the at least one processor to provide guidance to a subject undergoing olfactory training by the method disclosed herein, and / or follows up on activities carried out by the subject as part of the olfactory training, is provided.

[0031] Thereby, a tool in the form of an app (application), such as a mobile device or a computer, for example, is provided, which further facilitates the continuation and completion of the olfactory training program.

[0032] According to another aspect, a kit of nose plugs for use in the disclosed method of olfactory training, the kit comprising - two or more nose plugs for two or more different scents, each nose plug containing a single type of aromatic substance or a mixture of substances perceived as a scent, and - instructions for use is provided.

[0033] Therefore, since it is advantageous for the olfactory program to include exposing the subject to a plurality of aromatic substances or mixtures of substances perceived as scents over time, it is convenient to provide the subject with different sets of nose plugs each containing a different aromatic substance or mixture of substances perceived as a scent. This improves the subject's compliance rate and increases the likelihood of success of the olfactory training program.

[0034] In some embodiments, the aromatic substance is selected from the group including menthol, cherry, melon, rosemary, clove, cocoa, cola, coffee, citrus fruits such as orange and lemon, carnation, rose, vanilla, strawberry, peach, banana, apple, clove, jasmine, cinnamon, honey, jam, juice, syrup, peanut butter, coconut oil, basil, oregano, parsley, coriander, lavender, cardamom, thyme, caraway, eucalyptus, ketchup, garlic, tuna, boiled egg, soybean, coffee, tea, toothpaste, and soap. In some embodiments, the aromatic substance is selected from the group including strawberry, vanilla, lemon, melon, rosemary, menthol, cherry, orange, peach, cola, lavender, clove, cocoa, coffee, citrus fruits, carnation, rose, banana, apple, clove, and cinnamon.

[0035] This allows for the combination of multiple different aromatic substances selected from different types of scents, supporting both training success and ease of use.

[0036] According to some embodiments, the kit includes at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, and 15 different nose plugs containing different aromatic substances or mixtures of substances perceived as odors.

[0037] Therefore, the contents of the kit provided in this disclosure may be modified according to individual olfactory training programs and the needs of the subjects.

[0038] According to some embodiments, the kit includes a nasal plug for a mixture of about 10 different aromatic substances, or substances perceived as odors.

[0039] In some situations, it has been found beneficial for the kit to contain a mixture of approximately 10 different aromatic substances, or substances perceived as odors.

[0040] In some embodiments, the kit may include multiple nasal plugs for each mixture of aromatic substances or substances perceived as odors, so that a new nasal plug is used each time the subject's nostrils are exposed to a particular odor.

[0041] In an alternative embodiment, the kit may contain a limited number of nasal plugs for each mixture of aromatic substances or substances perceived as odors, so that each nasal plug for a particular mixture of aromatic substances or substances perceived as odors may be reused two or more times within a specific period.

[0042] Because the effectiveness of the aromatic substances, or mixtures of substances perceived as odors, associated with nasal plugs may diminish over time, and / or the nasal plugs themselves may be damaged or contaminated, kits containing multiple nasal plugs with the same aromatic or odor-perceived mixture may be advantageous in some training programs. For example, a kit may contain two, three, four, five, six, seven, eight, nine, or ten nasal plugs for each aromatic or odor-perceived mixture. However, the nasal plugs described herein are adapted for use for at least eight hours per day, if necessary.

[0043] In another embodiment, a nasal plug for use in an olfactory training program is disclosed. Such a nasal plug is provided favorably in the kit disclosed above for use in the manner disclosed, and is preferably fitted to be inserted into the nostril of a human subject, and the nasal plug comprises a structural molding material and an aromatic substance, or a mixture of aromatic substances perceived as an odor, wherein the aromatic substance, or mixture of aromatic substances, is uniformly dispersed in the structural molding material.

[0044] The term "structural molding material" means having a structurally molded shape, such as a plug portion, that is adapted for insertion into the nostrils. In some embodiments, the structural molding material essentially forms the entirety of the nostril, while in other embodiments, the entire nostril includes the structural molding material.

[0045] In some embodiments, the structural molding material is a plastic material, polymer material, or cellulosic material, preferably one of the following: silicone elastomer, thermoplastic elastomer (TPE), polyethylene (PE), polyethylene terephthalate (PET), polyvinyl chloride (PVC), polyurethane (PUR), fluoropolymer (PTFE, FEP, PFA, EFTE, ECTFE, PVDF), polyamide (PA), polypropylene (PP), polystyrene (PS), polylactic acid (PLA), polycarbonate (PC), polyether ether ketone (PEEK), polylactic acid (PLA) plastic, or polyhydroxyalkanoate (PHA) plastic, molded paper pulp, or molded cellulose fiber pulp.

[0046] As illustrated in the embodiments described further, the term “nasal plug” does not mean a device that obstructs the inflow and outflow of air into and out of the nose. In practice, nasal plugs are adapted to allow air to flow freely during breathing, and in some embodiments, by extending the airflow path, allow the air to be in contact with the aromatic substance, or mixture of aromatic substances, for a longer period of time before passing through the device. Various configurations of such nasal plugs are possible.

[0047] In a preferred embodiment, the nose plug is - At least one flexible member, -One rigid, elongated support member and Equipped with, - The flexible member is arranged to surround the support member. - The flexible member is adapted to be positioned inside the nostril so that the opening of the nostril is precisely filled, and the flexible member is provided with means by which a plurality of plates or bands guide the airflow entering the nostril in a meandering or spiral path, and at least the flexible member contains a mixture of at least one aromatic substance or substance perceived as an odor, uniformly dispersed in the structural molding material.

[0048] In this embodiment, the flexible member comprises the plug portion of the nose plug.

[0049] In some embodiments, the entire nose plug comprises a mixture of at least one aromatic substance or a substance perceived as an odor, uniformly dispersed in a structural molding material.

[0050] In other embodiments, the nose plug is - A long, slender support member, - One or two round retaining members are positioned at each end of the elongated support member, the retaining members being fitted to be inserted into the nostrils with their distal ends facing inward and their proximal ends adjacent to the opening of the nostrils, and It is equipped with, -Each of the holding members has a bell-shaped cross-section in at least one plane in the distal-proximal extending direction, -The holding members are, - The round distal part, - An open proximal portion comprising an outer rim circumferentially arranged along the outer circumference of the proximal portion, the outer rim extending radially outward from the retaining member, - An intermediate waist portion located between the distal portion and the proximal portion, the intermediate portion having at least one outer circumference in a plane essentially transverse to the distal-proximal direction, wherein the outer circumference is smaller than at least the maximum outer circumference of each of the distal portions. It is equipped with, - The outer rim, which is circumferentially positioned along the outer circumference of the proximal portion, is fitted to engage with the opening of the nostril and protrude outward from the nostril when the nasal device is placed inside the nostril. -The round distal portion is provided with one or more through holes adapted to allow air to pass through the distal portion, -At least the holding member includes a mixture of at least one aromatic substance or a substance perceived as an odor, uniformly dispersed in the structural molding material.

[0051] In this embodiment, the retaining member includes the plug portion of the nose plug.

[0052] This provides subjects with a convenient device by using nasal plugs containing aromatic substances used for olfactory training, thereby facilitating the implementation of a systematic training program.

[0053] In some embodiments, the nose plug is integrally molded, and as a result, the entire nose plug contains a mixture of at least one aromatic substance or substance perceived as an odor, uniformly dispersed in the structural molding material. This has the advantage of simplifying manufacturing because there is only one molding step. Integral molding also reduces the risk of defects in the structural integrity of the device.

[0054] According to some embodiments, a mixture of at least one aromatic substance, or a substance perceived as an odor, is uniformly dispersed throughout the structural molding material or on the surface of the structural molding material.

[0055] This allows the nasal plug to be used for extended periods without losing its ability to release fragrance, and can also be reused to improve olfactory sensitivity.

[0056] In some embodiments, the aromatic substances (of multiple types) are provided in an “oily” or liquid form, or are suitable for dissolving or dispersing in an oily solvent or other similar organic solvent. “Oily form” is defined herein as including substances that themselves exhibit properties similar to oil, such as biocompatibility, appropriate viscosity, and odor diffusion ability. In addition, “oily form” also includes substances in any oily solvent or organic solvent that have properties similar to oil, such as biocompatibility, appropriate viscosity, and odor diffusion ability. An example of a substance in oily form is menthol oil.

[0057] In some embodiments, the aromatic substance is selected from the group including menthol, cherry, melon, rosemary, clove, cocoa, coffee, cola, citrus fruits such as orange and lemon, carnation, rose, vanilla, strawberry, peach, banana, apple, clove, jasmine, cinnamon, honey, jam, juice, syrup, peanut butter, coconut oil, basil, oregano, parsley, coriander, lavender, cardamom, thyme, caraway, eucalyptus, ketchup, garlic, tuna, boiled egg, soybean, coffee, tea, toothpaste, and soap. In some embodiments, the aromatic substance is selected from the group including strawberry, vanilla, lemon, melon, rosemary, menthol, cherry, orange, peach, cola, lavender, clove, cocoa, coffee, citrus fruits, carnation, rose, banana, apple, clove, and cinnamon. Typically, any aromatic substance or mixture of substances perceived as an odor may be used that is distinct and pleasant to the user, but not too strong or irritating.

[0058] Multiple aromatic substances may be used, provided that the aromatic substances can be uniformly dispersed in the structural molding material of the nasal plug or effectively coated on the surface of the structural molding material of the nasal plug, and that the aromatic substances are useful in the training program. Typically, in the training program, several different types of aromatic substances are combined to obtain the desired results.

[0059] According to some embodiments, if the nasal plug has two parts for insertion into separate nostrils, each side can contain a different aromatic substance, and as a result, each nostril is exposed to a different aromatic substance. According to other embodiments, if the nasal plug has two parts for insertion into separate nostrils, each side can contain a specific aromatic substance at different concentrations, and as a result, each nostril is exposed to different amounts of the aromatic substance.

[0060] According to some embodiments, an aromatic substance is added to a structural molding material at an administration concentration within a range of aromatic or odor-dependent time intervals sufficient to produce a distinct odor.

[0061] Therefore, the amount and / or concentration of the added aromatic substance is important in order to achieve longer-term use of the nasal plug and for the fragrance to be perceived by the subject at an appropriate odor intensity. The actual concentration of the substance may vary depending on the fragrance used and / or the odor to be achieved.

[0062] According to some embodiments, the structural molding material is manufactured from a thermoplastic elastomer, in which a mixture of aromatic substances, or substances perceived as odors, is uniformly dispersed within the thermoplastic elastomer.

[0063] Therefore, aromatic substances, or mixtures of substances perceived as odors, may be dispersed in the structural molding material instead.

[0064] According to some embodiments, the structural molding material is coated with a coating containing an aromatic substance or a mixture of substances perceived as having an odor.

[0065] Alternatively, the structural molding material may be coated with a mixture of aromatic substances or substances perceived as odors, or a composition containing a mixture of aromatic substances or substances perceived as odors.

[0066] The effects and characteristics of the nasal plugs described herein are substantially similar to those described above in relation to the methods, computer programs, and kits. The embodiments of the disclosed nasal plugs referred to herein are substantially compatible with the kits and methods described herein.

[0067] This disclosure will become apparent from the following detailed description. The detailed description and specific examples disclose preferred embodiments of this disclosure for illustrative purposes only. Those skilled in the art will understand from the detailed description that changes and modifications are possible within the scope of this disclosure.

[0068] Therefore, it should be understood that the disclosures disclosed herein are not limited to specific components of the described apparatus or steps of the described method, for such apparatuses and methods may vary. It should also be understood that the terms used herein are for the purpose of describing specific embodiments only and are not intended to be limiting. It should be noted that the articles “a,” “an,” “the,” and “said” used herein and in the appended claims are intended to mean that there is one or more elements unless explicitly stated otherwise in the context. For example, the expression “a device” or “the device” may include multiple devices. Furthermore, phrases such as “comprising,” “including,” and “containing” do not exclude other elements or steps. [Brief explanation of the drawing]

[0069] The purposes of this disclosure, as well as any additional purposes, features, and benefits, will be more fully understood by referring to the following exemplary and non-limiting detailed description relating to exemplary embodiments of this disclosure, in conjunction with the accompanying drawings. [Figure 1] This is a perspective view showing one aspect of a nose plug. [Figure 2] This is a view of the nose plug shown in Figure 1 from above. [Figure 3] This figure shows a cross-section along AA in Figure 2. [Figure 4] This figure shows a cross-section along BB in Figure 2. [Figure 5] This figure shows a nose plug molded using 2K technology. [Figure 6] This is a diagram showing one form of a nose plug. [Figure 7] This is a perspective view showing the spiral shape of the nose plug. [Figure 8] This is a view from above of the spiral shape of the nose plug. [Figure 9a] This is a perspective view showing another aspect of the nose plug. [Figure 9b] This is a perspective view showing another aspect of the nose plug. [Figure 10a] This is a perspective view showing yet another aspect of the nose plug. [Figure 10b] This is a perspective view showing yet another aspect of the nose plug. [Figure 11] This diagram shows a nose plug and how it can be positioned in the user's nostrils. [Figure 12] This figure shows a graph comparing the improvement in olfactory sense when using the method disclosed herein with standard care. [Figure 13] This figure shows a graph comparing user compliance rates when using the methods, kits, and nasal plugs disclosed herein with standard care.

[0070] Detailed explanation This disclosure is described with reference to the accompanying drawings, which illustrate preferred embodiments of the disclosure. However, the disclosure may be implemented in other forms and should not be construed as being limited to the embodiments disclosed herein. The disclosed embodiments are provided to fully convey the scope of the disclosure to those skilled in the art.

[0071] As used herein, the term “aromatic substance” encompasses both individual aromatic substances and mixtures of aromatic substances that are collectively perceived as an odor. Furthermore, the terms “odor” and “aromatic substance” may be used interchangeably, both intended to refer to a specific smell.

[0072] Methods for training the sense of smell One aspect of this disclosure is a method for training the sense of smell, the method being: a. Providing a subject with at least two or more nasal plugs fitted to be inserted into the nostrils of a human subject, wherein the nasal plug comprises a structural molding material and an aromatic substance, or a mixture of aromatic substances collectively perceived as an odor, wherein the aromatic substance, or mixture of aromatic substances, is uniformly dispersed in the structural molding material, and each of the two or more nasal plugs comprises a different aromatic substance, or a mixture of aromatic substances collectively perceived as an odor, b. The step of exposing at least one nostril of the subject to two or more nasal plugs, one at a time, in a predetermined order and for a predetermined period of time, c. A method for training the sense of smell is provided, comprising the step of repeating the exposure step daily over a predetermined training period.

[0073] For an olfactory training program to be successful, it is typically essential to plan and structure the program in a manner that is tailored to the individual needs of each subject and the severity of their loss of smell. Therefore, the training program may be modified to suit the subject's needs depending on whether the subject is experiencing partial or complete loss of smell and whether the cause of the loss of smell is medical. It is also important that the subject is motivated to complete the training program, which is often a challenge in long-term training programs. In addition, training programs typically require regular and frequent (e.g., daily) training, and often require dedicating specific hours of the day solely to training, which can be difficult to coordinate with the subject's other daily routines and lifestyle. Therefore, one of the main advantages of the solution of this disclosure is that the use of nasal plugs and nasal plug kits designed for training can facilitate such training by lowering the hurdles to completing the training program over time. Furthermore, the design of the nasal plugs according to this disclosure is suitable for training because it allows for efficient exposure to aromatic substances and is easy to use.

[0074] In another embodiment, the step of exposing the nostrils to the nasal plug includes the action of applying the nasal plug to the nostrils by having the subject insert the nasal plug at least partially into the nostrils. Figure 11 shows an example of a nasal plug 1 and how the nasal plug may be intended to be positioned in the user's nostrils. The left side of the figure shows a lateral cross-sectional view of the nose with the nasal plug inserted, and the right side of the figure shows a frontal cross-sectional view of the nose with the nasal plug inserted. Preferably, the nasal plug is inserted about 15-20 mm into the lower part of the nasal cavity using the hand.

[0075] In a further embodiment, the step of exposing the nostrils to the nasal plug includes leaving the nasal plug in the nostrils for at least about 5 minutes, more preferably about 10 minutes.

[0076] In some embodiments, exposing a subject's nostrils involves leaving a nasal plug in the nostril for approximately 10, 15, 20, 25, or 30 minutes. In most cases, the preferred exposure time is 10 to 15 minutes per mixture of substances perceived as aroma or odor.

[0077] In some embodiments, the order in which subjects are exposed to aromatic substances or mixtures of substances perceived as odors is changed daily according to a predetermined plan. Thus, by exposing subjects to changes in exposure to aromatic substances or mixtures of substances perceived as odors, improvement in olfactory training can be achieved.

[0078] In some embodiments, at least two different nose plugs containing different aromatic substances or mixtures of substances perceived as odors are arranged in a predetermined order.

[0079] In some embodiments, the predetermined sequence is that on day 1, the subject is exposed to a mixture of at least four different aromatic substances or substances perceived as odors, and on day 2, the subject is exposed to a mixture of at least one more aromatic substance or substance perceived as an odor compared to day 1. This principle may be extended over longer periods, such as 10 consecutive training days, and as a result, for example, a training program involving training with a mixture of 10 different aromatic substances or substances perceived as odors may be modified so that the sequence in which the subject is exposed to the mixture of aromatic substances or substances perceived as odors in daily training is repeated every 10 days.

[0080] In some embodiments, the duration of the training program is at least one or two weeks, one month, or at least two to four months, and in some cases extends to longer periods such as six to twelve months.

[0081] In some embodiments, subjects are exposed to a mixture of aromatic substances or substances perceived as odors for five days a week, and the subjects take two days off from training per week.

[0082] In some embodiments, the prescribed training period is approximately 8 weeks in total. In some embodiments, the patient is exposed to four different odors for a total of 40 minutes each day. This exposure is preferably divided into four 10-minute sessions, two in the morning and two in the evening. In each session, at least one odor different from the previous session is presented, and each session lasts for 10 minutes.

[0083] In a further embodiment, the aromatic substances, or mixtures of substances perceived as odors, are selected from the group including strawberry, vanilla, lemon, melon, rosemary, menthol, cherry, orange, peach, cola, lavender, clove, cocoa, coffee, citrus fruits, carnation, rose, banana, apple, clove, and cinnamon.

[0084] In some embodiments, the step of exposing the subject's nostrils includes fully inserting at least one flexible member into the nostrils such that only the support member remains outside the nostrils. This provides efficient and optimized exposure to aromatic substances, thereby supporting olfactory training.

[0085] In some aspects, this training is for the treatment of olfactory hypoesthesia, anosmia, and / or heterosmia. Depending on whether the loss of smell is partial or complete, the training program may need to be adjusted.

[0086] In some aspects, olfactory impairment, anosmia, and / or heterosmia may be caused by the subject having or having had an infection, coronavirus infection, sequelae of coronavirus infection, head trauma and / or neurological injury, Parkinson's disease, Alzheimer's disease, stroke, or depression. Therefore, the cause of loss of smell may vary from subject to subject, which may also affect the olfactory training program proposed to the subject.

[0087] Sense of smell training app In yet another aspect, a computer program is provided for use in olfactory training according to the present disclosure, which, when executed on at least one processor, includes instructions causing at least one processor to provide guidance to a subject undergoing olfactory training and / or to follow up on activities performed by the subject as part of the olfactory training.

[0088] Such computer programs may be implemented in the form of mobile “apps” or on computers or any other user-friendly digital devices, and may help subjects carry out the training program on a daily and systematic basis and to follow up on the progress of the training program. For example, the “app” may include reminders to subjects regarding timing, duration, aroma and / or nasal plug selection, thereby facilitating the continuation and completion of the training program. In addition, the “app” may display progress reports to the user. The “app” may also include features related to follow-up on the progress and results of the experience. That is, subjects may be asked to provide information on the progress of their olfactory training experience, and based on the feedback from subjects, the training program may be adjusted in terms of frequency, dosage, aromas to be exposed to, duration, etc. Furthermore, the “app” may also include features for data collection and / or sharing data with physicians or other stakeholders, with the intention of providing further feedback and / or developing improved methods and kits.

[0089] Nose plug kit Another aspect of this disclosure shows a kit of nasal plugs for use in an olfactory training program by the method for olfactory training disclosed herein. This kit is -At least two or more nose plugs for a mixture of at least two different aromatic substances or substances perceived as odors, each nose plug containing a mixture of one aromatic substance or substance perceived as an odor, - Instructions for use and Includes.

[0090] The nasal plug kit includes at least two different nasal plugs, each containing one type of aromatic substance or mixture of substances perceived as odors, and as a result, the kit is intended to contain the aromatic substances or mixture of substances perceived as odors necessary to carry out a given olfactory training program. Such olfactory training programs may vary among subjects and according to the subjects' needs. For example, a training program aimed at restoring olfactory sensitivity as a result of partial or complete loss of smell may have different training designs in terms of the number and types of aromatics included and the duration of the training program, and consequently, the contents of the kit used for the training program may also vary accordingly.

[0091] In some embodiments, the kit includes at least two, three, four, five, six, seven, eight, nine, ten, eleven, twelve, thirteen, fourteen, fifteen, or more different nose plugs containing different aromatic substances or mixtures of substances perceived as odors.

[0092] Furthermore, depending on the needs of the subjects, such as the severity of loss of smell, it may be beneficial to provide nasal plugs with different concentrations and / or amounts of aromatic substances. Therefore, the kit may include nasal plugs with different concentrations and / or amounts, such as low, moderate, and / or high concentrations / amounts.

[0093] In some embodiments, the kit includes nasal plugs for approximately 10 different aromatic substances, or mixtures of substances perceived as odors, thereby providing a kit that can be used in a wide range of training programs involving multiple different types of aromatic substances. For example, a kit suitable for the exemplary training program in Table 1 includes nasal plugs for 10 different aromatic substances, or mixtures of substances perceived as odors, and the nasal plugs in the kit should be usable with sufficient efficiency for a period of, for example, four months. In such cases, the kit may need to include multiple nasal plugs for each mixture of aromatic substances, or mixtures of substances perceived as odors, and as a result, any malfunctions of individual nasal plugs are taken into consideration. For example, the kit may include two nasal plugs for each mixture of aromatic substances, or mixtures of substances perceived as odors, and therefore a total of 2 × 10 nasal plugs would be included for the training program according to Table 1. In other embodiments, the kit may include only one nasal plug for each mixture of aromatic substances, or mixtures of substances perceived as odors, and it is intended that the user reuses each nasal plug over several sessions.

[0094] In some embodiments, the kit includes multiple nasal plugs for each mixture of aromatic substances, or substances perceived as odors, and as a result, nasal plugs containing a particular mixture of aromatic substances, or substances perceived as odors, are replaceable as a result of loss of function of the nasal plug, such as loss of the effect of the aromatic substance or mechanical failure. This provides a kit that facilitates the completion of an olfactory training program, which typically lasts several months, thereby increasing the likelihood that the subject will succeed in regaining full or maximum sense of smell.

[0095] nose plug The nasal plugs disclosed herein for use in olfactory training programs are adapted to be inserted into the nostrils of human subjects, and each nasal plug comprises a structural molding material and an aromatic substance, or a mixture of aromatic substances perceived as an odor, wherein the aromatic substance, or mixture of aromatic substances, is uniformly dispersed in the structural molding material. The term “structural molding material” means that the nasal plug has a structural molding shape or plug portion adapted to be inserted into the nostrils.

[0096] The structural molding material is preferably manufactured from one or a combination of any moldable material suitable for use in the nostrils. Examples include plastic materials, various polymer materials, or cellulosic materials such as silicone elastomers, thermoplastic elastomers (TPE), polyethylene (PE), polyethylene terephthalate (PET), polyvinyl chloride (PVC), polyurethane (PUR), fluoropolymers (PTFE, FEP, PFA, EFTE, ECTFE, PVDF), polyamide (PA), polypropylene (PP), polystyrene (PS), polylactic acid (PLA), polycarbonate (PC), polyether ether ketone (PEEK), polylactic acid (PLA) plastics, polyhydroxyalkanoate (PHA) plastics, molded paper pulp, or molded cellulose fiber pulp.

[0097] A preferred embodiment of the present disclosure shown in Figures 1 to 8 is a nasal plug for use in an olfactory training program, wherein the nasal plug is -At least one flexible member 2, -One rigid, elongated support member 3 and Equipped with, - The flexible member is arranged to surround the support member. The present invention relates to a nasal plug characterized in that the flexible member is fitted to be positioned inside the nostril so as to precisely fill the opening of the nostril, and the flexible member is provided with means for guiding the airflow entering the nostril through a meandering or spiral path by a plurality of plates or bands, and the flexible member contains at least one type of aromatic substance.

[0098] The term "nasal plug" as used in this application does not mean a plug that completely blocks the nostrils. While the flexible member fills the nostrils, it is not intended to obstruct airflow, but rather to prevent air from directly entering the nose. In fact, the disclosed nasal plug may facilitate the inflow and outflow of air to the nose for many users, because the configuration of the flexible member is thought to slightly widen the nostrils and / or support a more open shape of the nostrils when placed in the nostrils. By allowing air to flow through the winding structure and thus travel a longer distance than without the nasal plug, subjects using the nasal plug of this disclosure will experience an enhanced sensation of any aromatic substances contained in the nasal plug.

[0099] In another embodiment shown in Figures 10a, 1b, 11a, and 11b, the nose plug is A long, slender support member (2,62), One or two round retaining members (3,63), each positioned at the respective end of the elongated support member (2,62), wherein the retaining members (3,63) are fitted to be inserted into the nostril with their distal end facing into the nostril and their proximal end adjacent to the opening of the nostril, and It is equipped with, Each of the retaining members (3,63) has a bell-shaped cross-section in at least one plane in the distal-proximal extending direction, The retaining members (3, 63) are, respectively, The round distal part (5) and An open proximal portion (7), comprising an outer rim (8,68) circumferentially arranged along the outer circumference of the proximal portion (7), the outer rim (8,68) extending radially outward from the retaining member (3,63), An intermediate waist portion (9) is positioned between the distal portion (5) and the proximal portion (7), wherein the intermediate portion (9) has at least one outer circumference in a plane essentially transverse to the distal-proximal direction, and the outer circumference is smaller than at least the maximum outer circumference of each of the distal portions (5), comprising the intermediate waist portion (9), The outer rims (8, 68) arranged circumferentially along the outer circumference of the proximal portion (7) are fitted to engage with the opening of the nostril and protrude outward from the nostril when the nasal device is placed inside the nostril. The round distal portion (5) is provided with one or more through holes (6, 66) adapted to allow air to pass through the distal portion (5), At least the retaining member (3,63) includes a mixture of at least one aromatic substance or a substance perceived as an odor, uniformly dispersed in the structural molding material.

[0100] Preferably, the aromatic substance is uniformly dispersed throughout the structural molding material or coated over the entire surface of the structural molding material.

[0101] One of the structural molding materials for nose plugs according to this disclosure, and one suitable material for incorporation as an optional support member, may be prepared by mixing 3 parts of an aromatic substance with 97 parts of a thermoelastic polymer, thereby providing a thermoelastic polymer containing about 3% of the aromatic substance. Another suitable material may be prepared by mixing 7 parts of an aromatic substance with 93 parts of a thermoelastic polymer, thereby providing a thermoelastic polymer containing about 7% of the aromatic substance. In some embodiments, the structural molding material may be manufactured from a thermoplastic elastomer and an aromatic substance, with the aromatic substance constituting a proportion in the range of 2% to 20%, more preferably 3% to 10%, of the total material in the structural molding material. In some embodiments, the aromatic substance constitutes about 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, or 20% of the material in the structural molding material.

[0102] Aromatic substances can also be incorporated into or added to the structural molding material of the nasal plug so that a sustained-release effect is achieved, i.e., the release of the aromatic substance is dispersed over the extended lifespan of the nasal plug and / or the release rate increases or decreases over time in accordance with the subject's training program. For example, the aromatic substance can be uniformly dispersed throughout the molded nasal plug and then gradually diffused from the nasal plug material over a period of time.

[0103] The concentration and / or amount of each aromatic substance in the structural molding material of the nasal plug should be at a level where the odor of the aromatic substance from the nasal plug can be clearly identified when exposed in the nostrils of a subject experiencing loss of smell. Furthermore, the odor of the aromatic substance should not be at a level that causes the subject to experience unpleasantness and / or annoyance. Therefore, different individual concentrations / amounts may be required for each subject depending on the severity of their loss of smell. Accordingly, in some embodiments, nasal plugs with, for example, low, medium, and high concentrations and / or amounts of aromatic substances may be provided, and as a result, an appropriate level of concentration and / or amount can be selected for a particular subject.

[0104] Figure 1 shows a nose plug 1 comprising a pair of flexible members 2 containing an aromatic substance and a rigid, elongated support member 3 adapted to stabilize the flexible members. In this embodiment of the nose plug, the pair of flexible members 2 comprises parallel plates 4 surrounding the support member. Spaces 5 exist between adjacent plates. Furthermore, these spaces communicate with each other through the plates. When the nose plug is placed in the nose and the flexible plates precisely fill the opening of the nostril, air entering the nostril first enters through a recess 7 in the lowest first plate as it passes through the nose plug. The airflow then winds its way through the nose plug and exits through a recess 6 in the topmost last plate. Exhaled air flows in the reverse direction. Therefore, both when air is inhaled and when air is exhaled, the air flows over a longer distance and is exposed to the aromatic substance in both directions than if the nose plug were not placed in the nostril.

[0105] As the air passes through the nose plug, it comes into contact with a flexible member containing aromatic substances. This embodiment shows that the path through which the air passes is considerably extended because the recesses every other plate are located on opposite sides in the circumferential transverse radial direction to the recesses of adjacent plates. Figure 4 clearly shows the recess 7 of the first plate, the recess 6 of the last plate, and all the recesses in between them. That is, the recess 7 of the bottommost first plate and the recesses of every other plate counting from the first plate have the same reference number, and the recess 6 of the topmost last plate and the recesses of every other plate counting from the last plate have the same reference number. This is valid when the number of plates is even (as shown in the embodiments of Figures 1 to 6), otherwise, when the number of plates is odd, the recesses of the first plate and the recesses of the last plate have the same reference number.

[0106] In the nasal plug configurations shown in Figures 1 to 6, a set of flexible members 2 containing an aromatic substance are adapted to guide the airflow entering the nostrils through a meandering or winding path. This is achieved when the nasal plug is placed in the nostrils. The airflow enters the nasal plug 1 through a recess 7 in the lowest plate 4, passes through the space 5 between two adjacent plates, namely the first plate and the second plate, and reaches the opposite transverse end of the first plate, where it is further guided through a recess 6 in the second plate. Subsequently, the airflow passes between two more adjacent plates, namely the second plate and the third plate, and reaches the opposite transverse end of the second plate, where it is further guided through a recess 7 in the third plate. The process is similar until the airflow passes between the top two plates and exits the nostrils through a recess 6 in the last plate.

[0107] In the embodiments shown in Figures 1 to 4, there are 6 plates, and in Figures 5 and 6, there are 8 plates. The number of plates may be other numbers, such as 7, 9, or 10. Preferably, the number of plates is in the range of 4 to 12.

[0108] Figure 2 shows the nose plug in the configuration of Figure 1 from above. As can be seen, plate 4 has an elliptical shape. The topmost and last plate is the smallest (in terms of transverse diameter and conjugate diameter), and the intermediate plates, i.e., plate numbers 4 and / or 5, are the largest plates. The first plate is somewhat larger than the last plate. Looking from the first plate, each subsequent adjacent plate up to the fourth or fifth plate has a somewhat larger diameter, and thereafter each subsequent adjacent plate has a somewhat smaller diameter. That is, from the first plate to the fourth or fifth plate, the transverse diameter and conjugate diameter increase with each plate, and from the fourth or fifth plate to the last plate, the transverse diameter and conjugate diameter decrease with each plate. The increase or decrease in each adjacent plate may be linear, but it may also proceed irregularly.

[0109] Figure 2 shows lines AA and BB. Line AA corresponds to the conjugate diameter of the plate, and line BB corresponds to the transverse diameter of the plate.

[0110] The flexible member 2 contains an aromatic substance. The aromatic substance may be incorporated into the material constituting the flexible member 2, for example, uniformly dispersed in the material. As is known in the art, the aromatic substance may also be coated onto the flexible member 2.

[0111] The flexible member 2 is preferably manufactured from a thermoplastic elastomer or other suitable polymer, in which the aromatic substance is uniformly dispersed throughout the thermoplastic elastomer using any suitable manufacturing technique. In one embodiment, the aromatic substance may be introduced into the thermoplastic elastomer or other suitable flexible material using an additive masterbatch method. In addition, or alternatively, the aromatic substance may be introduced by coating the flexible member, and in some embodiments the support member, with the aromatic substance, which is in a suitable solution or dispersed in the thermoplastic elastomer or other suitable material. Thus, the flexible member 2 may be manufactured from a thermoplastic elastomer coated with the aromatic substance on its surface.

[0112] Other flexible materials may be used for the flexible member and / or support member. The support member is preferably made from a thermoplastic polymer. Other rigid or stiff materials may also be used. In some embodiments, the support member and / or flexible member may further comprise one or more reinforcing members, such as an internal core formed of a more rigid and / or moldable material, thereby making part of the nose plug more rigid and / or allowing the support member to be press-fitted into an individual nose or nostril in a more fitted shape.

[0113] Figure 3 is a cross-sectional view along line AA. In this figure, a pair of flexible members 2 are integrally formed at both ends of the support member 3, and these flexible members 2 surround both ends of the support member 3. The support member 3 has a generally U-shape and has two pairs of flexible members 2 attached to it, one pair at each end. The support member 3 extending between the two ends has a curved shape, which facilitates handling.

[0114] Figure 4 is a cross-sectional view along line BB. This cross-section coincides with the transverse diameter of plate 4. Therefore, the recesses 6 of every two plates are shown on one side, and the recesses 7 of every two plates are shown on the opposite side.

[0115] As shown in Figure 5, the two legs of the roughly U-shaped support member 3 can be slightly inclined and / or angled relative to each other. This makes it easier to adjust the nasal plug to match the direction and position of the nostrils. The nasal plug needs to be properly positioned inside the nose without widening the nostrils more than necessary.

[0116] The nose plugs according to this disclosure can be manufactured using the 2K molding method, which involves integrally molding two materials. Thus, it is possible to first mold a support member from one material, and then directly mold a flexible member onto the support member using the same or different materials. This is shown in Figures 5-7. The same applies to nose plugs described later in relation to Figures 10a, 10b, 11a, and 11b. The manufacturing method of the nose plug may also include other techniques, such as extrusion molding, injection molding, casting, compression molding, pressure molding, or any other technique suitable for the materials used. In some embodiments, the entire nose plug may be manufactured using only one material; that is, the same material may be used for both the flexible or retaining member and the support member. In this case, the aromatic substance is diffused throughout the nose plug. Furthermore, the flexible or retaining member and the support member included in the nose plug according to this disclosure may be manufactured by separately molding them using the same or two different materials, and then assembling the two members. In this case, the aromatic substance content may be adapted according to the different parts of the nose plug. For example, one part may contain an aromatic substance or a mixture of aromatics, while the other part may not contain any aromatics. Another example is that different parts of the nose plug may contain different concentrations of aromatics, different types of aromatics, or mixtures of different aromatics.

[0117] This disclosure supports the conclusion that a highly effective, comfortable, and easy-to-use nasal plug can be obtained by combining air guided through a longer path that does not obstruct airflow with aromatic substances incorporated into the material of the nasal plug, and consequently along the entire surface of such a path, thereby improving the training of olfactory sensitivity in subjects experiencing partial or complete loss of smell. More specifically, as described above, the arrangement of the flexible member of the nasal plug allows air to be guided through a longer path than that of the nostrils without the nasal plug, while maintaining ease of breathing for the user. The combination of the arrangement of the flexible member and the aromatic substances incorporated into the material results in a remarkable effect on the subject's olfactory training.

[0118] This disclosure also points to long-term effects, concluding that the nasal plugs disclosed herein can be worn by the user for at least 8 hours and / or used repeatedly in shorter sessions over a longer period (up to 2, 3, 4, 5, 6 months, or longer) while maintaining a high level of effectiveness in perceiving the scent of aromatic substances.

[0119] Figure 6 shows an embodiment in which each nasal plug, each having a flexible member positioned on a support member, is adapted to be individually positioned in one of the nostrils.

[0120] Figure 7 is a perspective view showing an embodiment of a flexible member equipped with spirally arranged bands. This spiral structure provides an extended path for air entering the nostrils. The distance of the path can be changed by the pitch angle of the spiral wings of the bands. Recesses may also be provided in the spirally arranged bands. However, since air can enter even without recesses, this is not an essential feature.

[0121] Figure 8 is a top view of the embodiment shown in Figure 7. The spirally arranged bands shown in Figures 7 and 8 represent flexible members adapted to guide the airflow entering the nostrils along a spiral path.

[0122] Figures 10a and 10b show different perspective views of another embodiment of the nose plug, and Figures 11a and 11b show different perspective views of yet another embodiment of the nose plug. With respect to the material, a mixture of at least one aromatic substance or substance perceived as an odor uniformly dispersed in a structural molding material, and possible manufacturing techniques, these embodiments have the same characteristics as the embodiments described above.

[0123] The nasal plugs in Figures 10a, 10b, 11a, and 11b include semi-rigid, elongated support members 2,62. Each end of the support member 2,62 is provided with two round retaining members 3,63, the distal end 4 of each round retaining member being fitted to be inserted distally into the respective nostril. The shape of the retaining members provides a middle waist portion 9 fitted to "hang down" over the opening of the nostril, with a wider distal portion 5 and a wider proximal portion 7 providing a secure fit into the opening of the nostril. The outer rims 8,68 are circumferentially positioned along the outer circumference of the proximal portion 7, and the outer rims 8,68 engage with the opening of the nostril and are fitted to protrude outward from the nostril when the nasal device is placed inside the nostril.

[0124] The round distal portion 5 is provided with one or more through-holes 6,66 adapted to allow air to pass through the retaining members 3,63. In these embodiments of the nose plug, at least the retaining members 3,63 contain a mixture of at least one aromatic substance or substance perceived as an odor, uniformly dispersed in the structural molding material.

[0125] The embodiments and models described above are given as examples only and are not limited to the present invention. Other solutions, uses, purposes, and functions within the scope of the present invention as described in the appended claims should be obvious to those skilled in the art.

[0126] Those skilled in the art will understand that this disclosure is not limited to the preferred embodiments described above. They will further understand that modifications and variations are possible within the scope of the appended claims. Additionally, variations of the disclosed embodiments may be understood and performed by those skilled in the art in carrying out the claimed disclosure by examining the drawings, this disclosure, and the appended claims.

[0127] example Example 1 - Olfactory training plan A suitable training program (see Table 1) involves, for example, exposure of a subject to a mixture of four different aromatic substances, or substances perceived as odors, once or twice a day (e.g., morning and / or evening), for approximately 10 minutes per aromatic substance. Typically, such a training program can be continued for about four months. The aromatic substances to which the subject is exposed may also be changed daily. For example, if a subject is exposed to aromatic substances 1, 2, 3, and 4 on day 1, they may be exposed to aromatic substances 2, 3, 4, and 5 on day 2. After 10 days, the training program cycle is repeated.

[0128] [Table 1]

[0129] Example 2 - Nasal plug kit The nasal plug kit for use in the olfactory training plan of Example 1 may be designed as follows:

[0130] [Table 2]

[0131] Another example is a kit of 10 different fragrances, which includes 16 nose plugs for each fragrance. For example, the 10 fragrances may be strawberry, vanilla, lemon, melon, rosemary, menthol, cherry, orange, cola, and lavender. In other cases, one or more fragrances may be substituted, one or more may be optionally removed from the above list, and / or one or more of peach, banana, apple, clove, and other fragrances described herein may be added.

[0132] Example 3 - Mobile device app for use in olfactory training An app for training the sense of smell may have one or more of the following features:

[0133] • For scheduling and reminder purposes: Providing users with a systematic calendar to offer reminders that help organize and promote a consistent routine during their olfactory training sessions.

[0134] • For visualization purposes: Use of images to enhance the user experience and engagement during training sessions.

[0135] • For feedback purposes: Allows users to record subjective feedback about their sense of smell, quality of life, and progress over time, for personal reflection and self-awareness.

[0136] Example 4 - Study on the use of a method for olfactory training using nasal plugs. A randomized controlled trial involving 116 patients aged 18–65 years with functional olfactory impairment (95 women and 21 men) was conducted, randomly assigned to two different treatment conditions (https: / / classic.clinicaltrials.gov / ct2 / show / NCT06142565). This study was approved by the Swedish Ethics Review Board (Dnr: 2023-03779-01), and all participants provided written informed consent prior to enrollment. All procedures followed the Declaration of Helsinki. The two groups were similar in terms of age, sex, duration of olfactory impairment, and baseline olfactory measurement scores (Table 1). Inclusion criteria were a baseline functional olfactory impairment of 16.5–30.5, as defined by TDI (see definition below), and an age of 18–65 years. Exclusion criteria included that the cause of the olfactory dysfunction was psychiatric, nonviral, or nonidiopathic (e.g., head injury, surgery), and that the participant was currently participating in other olfactory training studies.

[0137] [Table 3]

[0138] At the time of the initial home visit, participants had experienced olfactory dysfunction for an average of 41 months. The second home visit took place an average of two months after the first. During the initial home visit, participants were randomly assigned to one of two olfactory training groups. Except for a specific type of olfactory training, both groups received treatments and procedures that appeared identical throughout the study period.

[0139] One group underwent other passive olfactory training using scented nasal plugs as described herein, while the other group underwent standard care olfactory training using scents found in the participants' own homes. The training was conducted at each participant's home on weekdays for two consecutive months, or eight weeks. While standard clinical practice recommended by the Swedish healthcare system typically involves 12 weeks of training therapy, the training was limited to eight weeks because the primary objective of this study was to address adherence rates. Training was conducted only on weekdays, not daily. These adjustments were made to avoid excessive dropouts, based on informal observations in the clinic that the patient dropout rate was approximately 80%.

[0140] More specifically, participants were randomly assigned to a nasal plug olfactory training (PT) group and provided with the scented nasal plugs described herein. Participants were instructed to wear the nasal plugs for 20 minutes in the morning and 20 minutes in the evening, Monday through Friday, for eight weeks. The nasal plugs were inserted as shown in Figure 11, and each was administered (released) a specific scent (vanilla, lemon, melon, rosemary, menthol, orange, peach, strawberry, cherry, or cola) upon insertion, while individuals were still able to maintain a nearly normal airflow through their nostrils. Participants were instructed to use one scented plug for 10 minutes and then switch to another scented plug for the remaining 10 minutes of the session. Participants were also instructed to visualize and focus on the odors during training, referring to images of the olfactory objects printed on the packaging of each individual nasal plug. All participants were contacted twice during their eight-week home training period, with information on how to contact them in case of questions, comments, or concerns. A text message was sent one week after the initial session, and a phone call was made approximately three weeks later.

[0141] Participants assigned to the standard care olfactory training group (ST) were instructed to select 4-6 household scents for 20 minutes each morning and evening, Monday through Friday, for 8 weeks. During training, participants were instructed to smell each item for 10-20 seconds, visualizing the scent and focusing on it. Similar to the PT group, all participants received two contacts during their 8-week home training period, along with contact information for questions, comments, or concerns. A text message was sent one week after the initial session, and a phone call was made approximately three weeks later. After the study, ST group participants were instructed to take home the same olfactory training kit provided to the PT group.

[0142] Subjective and objective scales related to olfactory dysfunction, as well as subjective scales related to quality of life and overall health status, were evaluated before and after treatment. The scales evaluated included the following:

[0143] Objective olfactory function was assessed using a standardized extended Sniffin' Sticks test (Burghart Messtechnik, Holm, Germany). Objective olfactory function was evaluated before and after 8 weeks of olfactory training. Odors were presented using a pen-shaped device, and nasal chemosensibility performance was assessed for odor detection threshold (T), odor quality distinction (D), and cue-assisted odor identification (I). These were totaled to generate a summary TDI score, which reflects overall olfactory function, with higher scores indicating better performance.

[0144] Subjective olfactory function was self-assessed using a 10-point visual analog scale (VAS) ranging from 0 (no sense of smell) to 10 (excellent sense of smell).

[0145] • Adherence rate included dropout rate and adherence. For adherence rate, participants were questioned about their experience during olfactory training, specifically focusing on participant adherence, asking about how often they actually completed olfactory training and how often they forgot to complete it. Dropout rate was defined as the percentage of individuals in each group who did not complete the final test session. This was obtained by counting the total number of participants who decided to discontinue participation either by notifying the experiment leader or by ending contact without explanation at any point before the second visit. A six-item questionnaire on treatment adherence (Haas et al. 2024) individually assessed consistency, perception of boredom, amnesia, and potential causes of training discontinuation. This questionnaire was presented to participants at their second visit.

[0146] Statistical analysis is performed using the statistical software R( v4.3.3; R Core Team 2024 The study was conducted using [tool name]. The significance level for statistical testing was set at α=0.05. The hypotheses, inclusion / exclusion criteria, and analysis design of this study are pre-registered at clinicaltrials.gov, ID NCT06142565.

[0147] The study results showed a slight improvement in objective olfactory function, as shown in Figure 12. Individuals who underwent training improved their olfactory function by an average of 3.5 scale steps, while patients in the standard care group improved by 1.8 scale steps (measured on a relative scale of 16–42). Both values ​​showed statistical improvement and were consistent with the subjective assessment of treatment.

[0148] Furthermore, regarding compliance rates, as shown in Figure 13, the group using nasal plugs (labeled "NOSA plugs" in the figure) had significantly fewer dropouts from training (6.7%) than the group using standard care training (labeled "standard care" in Figure 13) (23.2%). Figure 13 shows how many participants forgot to perform their daily training (frequently, sometimes, rarely, or never). Moreover, among the participants who completed the training, a significantly higher proportion never forgot their daily training (38.3% in the nasal plug group vs. 10.7% in the standard care group), indicating that a much larger number of participants performed the training regularly.

[0149] In conclusion, the use of nasal plugs and methods for olfactory training disclosed herein have shown significantly improved results in both olfactory function and adherence rates compared to standard care methods. Therefore, the methods, kits, and nasal plugs disclosed herein improve training outcomes for subjects requiring olfactory training. Furthermore, when participants were asked about their experience, they stated that using the nasal plugs described herein was easier than standard care methods and easier to incorporate into daily life, leading to a greater willingness to follow the treatment method. By using nasal plugs, users can perform their daily tasks while undergoing olfactory training. This is positive in many ways for individuals and society as a whole, and leads to cost savings in the healthcare system.

Claims

1. A method for training the sense of smell, the method is a. Providing a subject with at least two or more nasal plugs fitted to be inserted into the nostrils of a human subject, wherein each nasal plug comprises a structural molding material and an aromatic substance, or a mixture of aromatic substances collectively perceived as an odor, wherein the aromatic substance, or the mixture of aromatic substances, is uniformly dispersed in the structural molding material, and each of the two or more nasal plugs comprises a different aromatic substance, or a mixture of aromatic substances collectively perceived as an odor, b. The step of exposing at least one nostril of the subject to the two or more nasal plugs, one at a time, in a predetermined order and for a predetermined period of time, c. The step of repeating the exposure step every day for a predetermined training period. Methods for training the sense of smell, including [specific examples of methods].

2. The method for training the sense of smell according to claim 1, wherein the step of exposing the nostrils to the nasal plug includes the action of applying the nasal plug to the nostrils by the subject inserting the nasal plug at least partially into the nostrils.

3. The method for training the sense of smell according to claim 1 or 2, wherein the step of exposing the nostrils to the nasal plug allows the nasal plug to be left in the nostrils for at least about 5 minutes, more preferably about 10 minutes.

4. The method for training the sense of smell according to any one of claims 1 to 3, wherein the sequence in which the subject is exposed to the aromatic substance or a mixture of substances perceived as an odor is changed daily according to a predetermined plan.

5. A method for training the sense of smell according to any one of claims 1 to 4, wherein at least two different nose plugs containing different aromatic substances or mixtures of substances perceived as odors are used in the predetermined order.

6. The method for training the sense of smell according to any one of claims 1 to 5, wherein the predetermined sequence is that on day 1, the subject is exposed to a mixture of at least four different aromatic substances or substances perceived as odors, and on day 2, the subject is exposed to a mixture of at least one other aromatic substance or substance perceived as odor compared to day 1.

7. The method for training the sense of smell according to any one of claims 1 to 6, wherein the duration of the training program is at least one to two weeks, preferably at least one month, more preferably at least two to four months, the subject is exposed to the aromatic substance five days a week, and the subject takes two days a week off from the training.

8. A method for training the sense of smell according to any one of claims 1 to 7, wherein the step of exposing at least one nostril includes fully inserting the entirety of at least one flexible member into the nostril such that only the support member remains outside the nostril.

9. The method for training the sense of smell according to any one of claims 1 to 8, wherein the aromatic substance or mixture of substances perceived as smell is selected from the group including strawberry, vanilla, lemon, melon, rosemary, menthol, cherry, orange, peach, cola, lavender, clove, cocoa, coffee, citrus fruits, carnation, rose, banana, apple, clove, and cinnamon.

10. A method for training the sense of smell according to any one of claims 1 to 9, wherein the training is for the treatment of olfactory impairment, anosmia, and / or heterosmia.

11. The method for training the sense of smell according to claim 10, wherein the aforementioned olfactory impairment, anosmia, and / or heterosmia are due to the subject having or having had, an infectious disease, coronavirus infection, sequelae of coronavirus infection, head injury and / or nervous system injury, Parkinson's disease, Alzheimer's disease, and stroke.

12. A computer program for use in olfactory training according to any one of claims 1 to 11, wherein, when executed on at least one processor, the computer program includes instructions causing the at least one processor to provide guidance to the subject undergoing olfactory training according to any one of claims 1 to 11, and / or to follow up on activities performed by the subject as part of the olfactory training.

13. A kit of nasal plugs for use in the method for training the sense of smell according to any one of claims 1 to 11, the kit of nasal plugs is - A nose plug comprising at least two or more nose plugs for at least two or more different scents, each nose plug containing one type of aromatic substance or a mixture of substances perceived as an odor, - Instructions for use and A kit of nose plugs, including one.

14. The nasal plug kit according to claim 13, wherein the aromatic substance, or mixture of substances perceived as odor, is selected from the group including strawberry, vanilla, lemon, melon, rosemary, menthol, cherry, orange, peach, cola, lavender, clove, cocoa, coffee, citrus fruits, carnation, rose, banana, apple, clove, and cinnamon.

15. The kit of nose plugs according to claim 13 or 14, comprising at least two, three, four, five, six, seven, eight, nine, ten, eleven, twelve, thirteen, fourteen, fifteen, sixteen, seventeen, eighteen, nineteen, twenty, twenty-one, twenty-two, twenty-three, twenty-four, or twenty-five different nose plugs containing different aromatic substances or mixtures of substances perceived as odors.

16. The nasal plug kit according to any one of claims 13 to 15, wherein the nasal plug has different concentrations and / or amounts of the aromatic substance or mixture of substances perceived as odor, for example, low, medium, and / or high concentrations / amounts.

17. The kit of nose plugs according to any one of claims 13 to 16, wherein the kit comprises a nose plug for a mixture of about 10 different aromatic substances or substances perceived as odors.

18. The kit of nose plugs according to any one of claims 13 to 17, wherein the kit comprises a plurality of nose plugs for each mixture of aromatic substances or substances perceived as odors.

19. A nasal plug (1, 10) for use in an olfactory training program, wherein the nasal plug (1, 10) is fitted to be inserted into the nostril of a human subject, The nose plug (1, 10) comprises a structural molding material and an aromatic substance, or a mixture of aromatic substances that are collectively perceived as an odor, wherein the aromatic substance, or the mixture of aromatic substances, is uniformly dispersed in the structural molding material.

20. The nose plug according to claim 19, wherein the structural molding material is a plastic material, a polymer material, or a cellulose-based material.

21. The device further comprises at least one flexible member (2) and one rigid, elongated support member (3), wherein the flexible member is arranged to surround the support member. The flexible member is fitted to be positioned inside the nostril so that the opening of the nostril is precisely filled, and the flexible member is provided with means by which a plurality of plates or bands guide the airflow entering the nostril in a meandering or spiral path. At least the flexible member includes a mixture of at least one of the aromatic substances or substances perceived as odors, uniformly dispersed in the structural molding material. The nose plug according to claim 19 or 20.

22. moreover, Elongated support members (12, 62) One or two round retaining members (13, 63) are positioned at each end of the elongated support member (12, 62), wherein the retaining members (13, 63) are fitted to be inserted into the nostril with their distal end facing into the nostril and their proximal end adjacent to the opening of the nostril. It is equipped with, Each of the retaining members (13, 63) has a bell-shaped cross-section in at least one plane in the distal-proximal extending direction, The retaining members (13, 63) are, respectively, The round distal portion (15) and An open proximal portion (17), comprising an outer rim (18, 68) circumferentially arranged along the outer circumference of the proximal portion (17), the outer rim (18, 68) extending radially outward from the retaining member (13, 63), An intermediate waist portion (19) is positioned between the distal portion (15) and the proximal portion (17), wherein the intermediate waist portion (19) has at least one outer circumference in a plane substantially transverse to the distal-proximal direction, and the outer circumference is smaller than at least the maximum outer circumference of each of the distal portions (15). It is equipped with, The outer rims (18, 68) arranged circumferentially along the outer circumference of the proximal portion (17) are fitted to engage with the opening of the nostril and protrude outward from the nostril when the nasal device is placed inside the nostril. The round distal portion (15) is provided with one or more through holes (16, 66) adapted to allow air to pass through the distal portion (15), At least the holding members (13, 63) include a mixture of at least one aromatic substance or a substance perceived as an odor, uniformly dispersed in the structural molding material. The nose plug according to claim 19 or 20.

23. The nose plug is integrally molded, as described in any one of claims 19 to 22.

24. The nose plug according to any one of claims 19 to 23, wherein at least one of the aforementioned aromatic substances, or a mixture of substances perceived as odors, is uniformly dispersed throughout the structural molding material.

25. The nose plug according to any one of claims 19 to 24, wherein at least one of the aforementioned aromatic substances, or a mixture of substances perceived as odors, is uniformly dispersed on the surface of the structural molding material.

26. The nasal plug according to any one of claims 19 to 25, wherein the aromatic substance is provided in an "oily" or liquid form, or is suitable for dissolving or dispersing in an oily solvent or other similar organic solvent.

27. The nasal plug according to any one of claims 19 to 26, wherein the aromatic substance is selected from the group including strawberry, vanilla, lemon, melon, rosemary, menthol, cherry, orange, peach, cola, lavender, clove, cocoa, coffee, citrus fruits, carnation, rose, banana, apple, clove, and cinnamon.

28. The nasal plug according to any one of claims 19 to 27, wherein the aromatic substance or mixture of substances perceived as odors is added to the structural molding material at an administration concentration within a range of time intervals dependent on the aroma or odor.

29. The nose plug according to any one of claims 19 to 28, wherein the structural molding material is manufactured from a thermoplastic elastomer, and the mixture of the aromatic substance or substance perceived as an odor is uniformly dispersed in the thermoplastic elastomer.

30. The nose plug according to any one of claims 19 to 29, wherein the structural molding material is coated with a coating containing the aromatic substance or a mixture of substances perceived as odors.

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