Method for olfactory training, nose plug kit for use in olfactory training procedure and nose plug for use in olfactory training procedure

Abstract

The present disclosure relates to a method for olfactory training and a computer program for use in the olfactory training method using a nose plug adapted to be inserted into a nostril of a human subject wherein the nose plug comprises a structural molding material and an aromatic substance or aromatic substance mixture as an odor experience, and 5, uniformly dispersing the aromatic substance or the aromatic substance mixture in the structural molding material. The present disclosure also relates to a nose plug kit for use in an olfactory training procedure and a nose plug for use in an olfactory training procedure.

Description

Technical Field

[0001] This disclosure relates to a method for olfactory training and a computer program for use in an olfactory training procedure, a nasal plug kit for use in an olfactory training procedure, and a nasal plug for use in an olfactory training procedure, as defined in the introductory portion of the independent claims. Background Technology

[0002] Loss of olfactory sensation, whether complete loss (anosmia), partial loss (hypopnea), or olfactory detection dysfunction (olfactory paralysis, characterized by the brain's inability to correctly identify the natural smell of odors), is a relatively common condition for many people. There are many possible causes of loss of olfactory sensation, such as head injury, infection, or medical or mechanical blockage of the nose. Psychological factors can also significantly influence the experience of olfactory sensation loss, at least in part. Furthermore, mental illnesses such as depression are common among those experiencing olfactory sensation loss. Although the causes and severity of olfactory sensation loss vary, there are training programs that can partially or completely improve olfactory sensation, known as olfactory training programs.

[0003] Hummel et al. (“Effects of olfactory training in patients with olfactory loss”, Laryngoscopy Vol. 119: March 2009, pp. 496-499) discussed a training program for subjects with olfactory dysfunction, in which subjects were exposed to different odors over a period of time (12 weeks) during the training program. The study showed that structured short-term exposure to selected odors increased olfactory sensitivity, while the olfactory sensitivity of subjects who did not undergo the training program remained unchanged.

[0004] Pieniak et al. (“Olfactory training. Thirteen years of research reviewed”, Neuroscience and Biological Behaviour Review, Vol. 141 (2022) 104853) reviewed the research field of olfactory training.

[0005] Therefore, performing olfactory training to improve or restore lost odor perception appears to be crucial. Consequently, it is important to identify training procedures and associated devices that facilitate such training, thereby increasing the chances of successful development of an individual's olfactory sensitivity.

[0006] However, current training programs have been found to often fail to achieve the expected or desired results. Training programs designed for specific subjects often lack scientific basis, and it is difficult to control and track the subjects' ability to execute the training program as planned. Sometimes, this may be related to a lack of motivation among the subjects experiencing the training program, and / or practical difficulties and / or a lack of time for structured daily training. Furthermore, the efficiency and compatibility of currently used methods and equipment are also problematic.

[0007] Therefore, there is a need for improved equipment and training procedures using such equipment to improve the olfactory training outcomes for those in need. Summary of the Invention

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

[0009] The inventors have surprisingly discovered that one or more nasal plugs, structurally configured essentially as described in WO2011 / 162677 or WO2018 / 206388 (both incorporated herein by reference), further comprising at least one aromatic substance or mixture of aromatic substances as an odor experience—that is, a substance or mixture of substances capable of having a specific odor sensation that can be used for odor perception in training subjects—help train the olfactory sensitivity of subjects and patients in need. In particular, the method using nasal plugs for olfactory training improves odor perception more significantly by increasing subject compliance with the training procedure compared to conventional methods. This is primarily due to its ease of use and the ability to wear the device while performing daily tasks.

[0010] Therefore, according to the first aspect, a method for olfactory training is provided, comprising the following steps:

[0011] a. Providing an object with at least two or more nasal plugs suitable for insertion into the nostrils of a human object, the nasal plugs comprising a structural molding material and an aromatic substance or mixture thereof that serves as a common odor experience, the aromatic substance or mixture thereof being uniformly dispersed in the structural molding material, and each of the two or more nasal plugs comprising a different aromatic substance or mixture thereof that serves as a common odor experience.

[0012] b. Exposing at least one nostril of the object to two or more nasal plugs one at a time in a predetermined order and duration;

[0013] c. Repeat the exposure daily during the predetermined training period.

[0014] Therefore, a training procedure utilizing nasal plugs containing aromatic substances is provided to facilitate training for subjects and patients with various needs for developing olfactory sensitivity. The primary objective is to enhance an individual's ability to distinguish and be sensitive to different odors, particularly in the context of odor training and olfactory rehabilitation. In particular, the methods and apparatus disclosed herein are intended to be performed and used by the subjects themselves, i.e., by non-professionals.

[0015] According to another aspect, the step of exposing the nostrils to a nasal plug includes the action of applying the nasal plug to the nostrils by at least partially inserting it into the nostrils. Preferably, the nasal plug is inserted into the lower part of the nasal cavity about 15mm-20mm using the hand.

[0016] In a further aspect, the step of exposing the nostrils to the nasal congestion includes allowing the nasal congestion to remain in the nostrils for at least about 5 minutes, more preferably about 10 minutes.

[0017] Depending on some aspects, the order in which objects are exposed to aromatic substances or mixtures of substances as an olfactory experience varies daily according to a predetermined plan.

[0018] Therefore, structured and diverse training procedures are provided to enhance the olfactory sensitivity of objects.

[0019] According to some aspects, at least two different nasal plugs having different aromatic substances or mixtures of substances for odor experience are used in a predetermined order. In other aspects, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25 or more different nasal plugs having different aromatic substances or mixtures of substances for odor experience are used in a predetermined order.

[0020] Therefore, improvements can sometimes be observed by changing the order in which one is exposed to different aromatic substances or mixtures of substances as an odor experience.

[0021] According to some aspects, the predetermined sequence is as follows: on day 1, the subject is exposed to at least four different aromatic substances or mixtures of substances as an odor experience, and on day 2, the subject is exposed to at least one other aromatic substance or mixture of substances as an odor experience compared to day 1. Preferably, the predetermined sequence is that the subject is exposed to at least four different aromatic substances or mixtures of substances as an odor experience each day.

[0022] According to some aspects, the nasal plugs used in the described training procedure, when comprising two parts intended for use in individual nostrils, may include different aromatic substances on each side, such that each nostril is exposed to different aromatic substances or mixtures of substances as an odor experience. In other aspects, the nasal plugs used in the described training procedure, when comprising two parts intended for use in individual nostrils, may include different concentrations of the same aromatic substance or mixture of substances on each side, such that each nostril is exposed to a certain concentration of odor.

[0023] Therefore, by changing the training procedure in a structured way every day, improvements can usually be expected.

[0024] According to some aspects, the duration of the training program, i.e. the predetermined training period, is at least one month, and preferably at least two to four months, in which the subject is exposed to aromatic substances for five days a week and the subject rests for two days a week.

[0025] Therefore, for the benefit of those in need, structured procedures organized to help motivate and extend training are provided.

[0026] According to some aspects, exposing the nostrils involves fully inserting most of, for example, at least the entire flexible member of the nasal plug into the nostril, such that only the support member remains outside the nostril.

[0027] Therefore, the aromatic substance is expected to have a strong and / or optimized effect. Another advantage of inserting at least a large portion of the flexible component or retainer component completely or almost completely into the nostril is that only a small portion of the nasal plug protrudes from the nostril, presenting an inconspicuous visual experience, allowing users to perform their daily tasks without a bulky, visible, or obstructive device. It is worth noting that all aspects of the nasal plug described herein provide an inconspicuous use.

[0028] According to some aspects, aromatic substances or mixtures of substances that are used as olfactory experiences are selected from the group including: strawberry, vanilla, lemon, melon, rosemary, menthol, cherry, orange, peach, cola, lavender, clove, cocoa, coffee, citrus, carnation, rose, banana, apple, clove and cinnamon.

[0029] According to some sources, training is intended to treat hyposmia, anosmia, and / or olfactory inversion.

[0030] Therefore, the training program is designed for both medical and non-medical conditions in order to improve the olfactory sensitivity of subjects and patients with different needs.

[0031] According to some sources, decreased sense of smell, loss of smell, and / or olfactory inversion are the result of an individual having had or currently having an infection, COVID-19, post-COVID-19, head and / or nervous system injury, Parkinson's disease, Alzheimer's disease, stroke, or depression.

[0032] Therefore, these are examples of situations in which the olfactory training procedures disclosed herein are useful in cases of partial or complete loss of olfactory sensation.

[0033] According to another aspect, a computer program is provided for use in olfactory training according to the foregoing aspects, comprising instructions that, when executed on at least one processor, cause the at least one processor to provide guidance to an object undergoing olfactory training according to the methods disclosed herein, and / or track activities performed by said object as part of said olfactory training.

[0034] Therefore, a tool is provided, for example in the form of an application on a mobile device or computer, which further facilitates the continuation and completion of the olfactory training program.

[0035] According to another aspect, a nasal plug kit for use in the disclosed method for olfactory training is provided, the kit comprising:

[0036] - Two or more nasal plugs for two or more different odors, each nasal plug comprising an aromatic substance or mixture of substances for odor experience, and

[0037] - Instructions for use.

[0038] Therefore, since olfactory procedures advantageously involve exposing the subject over time to a variety of aromatic substances or mixtures of substances as odor experiences, it would be convenient to provide the subject with a different set of nasal plugs, each containing a different aromatic substance or mixture of substances as an odor experience. This improves subject compliance and the likelihood of a successful olfactory training procedure.

[0039] According to some aspects, aromatic substances are selected from the group including: menthol, cherry, melon, rosemary, clove, cocoa, cola, coffee, citrus fruits such as oranges and lemons, 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, tomato sauce, garlic, tuna, boiled eggs, soybeans, coffee, tea, toothpaste, and soap. According to some aspects, aromatic substances 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.

[0040] Therefore, by combining a variety of different aromatic substances selected from different types of odors, successful training and ease of use are supported.

[0041] According to some aspects, the kit includes at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15 different nasal plugs, which have different aromatic substances or mixtures of substances for olfactory experience.

[0042] Therefore, the contents of the kit according to this disclosure can vary depending on the individual olfactory training program and the needs of the subject.

[0043] According to some sources, the kit includes nasal plugs containing approximately 10 aromatic substances or mixtures of substances for olfactory experience.

[0044] In some cases, including about 10 different aromatic substances or mixtures of substances in the kit as an olfactory experience has proven beneficial.

[0045] According to some aspects, the kit includes multiple nasal plugs for each aromatic substance or mixture of substances used as an odor experience, so that a new nasal plug can be used whenever the subject's nostrils are exposed to a particular odor.

[0046] Alternatively, the kit may include a limited number of nasal plugs for each aromatic substance or mixture of substances used as an olfactory experience, such that each nasal plug for a particular aromatic substance or mixture of substances used as an olfactory experience can be reused two or more times during a specific time period.

[0047] Because the effects of the aromatic substances or mixtures of substances associated with the nasal plug as an odor experience may diminish over time, and / or the nasal plug itself may become broken or soiled, kits comprising multiple nasal plugs with the same aromatic substances or mixtures of substances for an odor experience may be advantageous in some training programs. For example, a kit may include 2, 3, 4, 5, 6, 7, 8, 9, or 10 nasal plugs for each fragrance or mixture of substances for an odor experience. However, if desired, the nasal plugs described herein are suitable for use for at least 8 hours daily.

[0048] In other respects, nasal plugs for use in olfactory training procedures are disclosed. Such nasal plugs are advantageously disposed in the kits disclosed above for use in the disclosed methods, and are preferably adapted for insertion into the nostrils of human subjects, wherein the nasal plugs comprise a structural molding material and an aromatic substance or mixture of aromatic substances as an odor experience, said aromatic substance or mixture of aromatic substances being uniformly dispersed in the structural molding material.

[0049] The term "structurally molded material" means that a nasal plug has a structurally molded shape, such as a plug portion adapted for insertion into the nostril. In some respects, the structurally molded material substantially forms the entire nasal plug; in others, the entire nasal plug comprises the structurally molded material.

[0050] In some respects, the structural molding material is a plastic, polymer, or cellulose-based material, preferably one of the following: 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), polyetheretherketone (PEEK), polyacetal (PLA) plastics or polyhydroxyalkanoate (PHA) plastics, molded pulp, or molded cellulose fiber pulp.

[0051] As illustrated in the further description, the term "nasal congestion" does not mean in any way that a device obstructs airflow into or out of the nose. In fact, nasal congestion is adapted to allow free airflow during breathing and, in some respects, to prolong the airflow path to allow the air to be in contact with aromatic substances or mixtures of aromatic substances for a longer period before passing through the device. Various configurations of such nasal congestion are conceivable.

[0052] In preferred embodiments, nasal conduits include:

[0053] -At least one flexible member, and

[0054] - A rigid, slender support member

[0055] -The flexible members are arranged to surround the supporting members, and

[0056] - A flexible member is adapted to be placed inside the nostril to accurately fill the opening of the nostril and is provided with means for guiding airflow into the nostril in a serpentine or spiral path through multiple plates or belts, wherein at least the flexible member includes at least one aromatic substance or mixture of substances uniformly dispersed in a structural molding material as an odor experience.

[0057] In this respect, flexible components include the plug portion of the nasal plug.

[0058] In some respects, the entire nasal plug comprises at least one aromatic substance or mixture of substances uniformly dispersed in a structural molding material as an odor experience.

[0059] Other symptoms of nasal congestion include:

[0060] - Slender support members, and

[0061] - One or two circular retainer members, each disposed at a corresponding end of the elongated support member, wherein the retainer members are adapted to be inserted into the nostril, wherein the distal end points into the nostril and the proximal end is adjacent to the nostril opening.

[0062] Each of the retainer components includes a bell-shaped cross-section in at least one plane in the distal-proximal extension.

[0063] -Each of the retainer components includes:

[0064] - The far part of the circle, and

[0065] - An open proximal portion, including an outer edge circumferentially disposed around the outer periphery of the proximal portion and extending radially outward from the retainer member, and

[0066] - A middle waist portion, disposed between the distal portion and the proximal portion, the middle portion having at least one outer circumference in a plane substantially transverse to the distal-proximal direction, the outer circumference being smaller than the corresponding maximum outer circumference of at least the distal portion.

[0067] - Wherein, when the nasal device is disposed in the nostril, the outer edge circumferentially disposed around the proximal portion is adapted to engage with the nostril opening and protrude outward from the nostril.

[0068] -The circular distal portion is provided with one or more through holes adapted to allow air to pass through the distal portion.

[0069] -At least one retainer component comprises at least one aromatic substance or mixture of substances uniformly dispersed in the structural molding material as an odor experience.

[0070] In this respect, the retainer component includes the plug portion of the nasal plug.

[0071] Therefore, by using a nasal plug containing aromatic substances for olfactory training, a convenient device is provided for the subject, making it easy for them to perform structured training procedures.

[0072] In some respects, the nasal plug is molded as a single piece, such that the entire nasal plug comprises at least one aromatic substance or mixture of substances uniformly dispersed in a structural molding material for odor experience. This is advantageous because manufacturing is simplified, requiring only a single molding step. One-piece molding also reduces the risk of any structural integrity defects in the device.

[0073] According to some aspects, at least one aromatic substance or mixture of substances, as an odor experience, is uniformly dispersed throughout the structural molding material or on the surface of the structural molding material.

[0074] Therefore, in order to improve olfactory sensitivity, nasal decongestants can be used for a long time without losing their aroma release and can also be reused.

[0075] In some respects, aromatic substances are provided in an "oily" or liquid form, or are suitable for dissolution or dispersion in oily solvents or other similar organic solvents. "Oily form" is defined herein as including substances that themselves exhibit properties similar to oils, such as biocompatibility, suitable viscosity, and odor diffusion ability. Furthermore, "oily form" also includes any substance in an oil-based or organic solvent that possesses oil-like properties, such as biocompatibility, suitable viscosity, and odor diffusion ability. An example of a substance in an oily form is peppermint oil.

[0076] According to some sources, aromatic substances are selected from the group including: menthol, cherry, melon, rosemary, clove, cocoa, coffee, cola, citrus fruits such as oranges and lemons, 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, tomato sauce, garlic, tuna, boiled eggs, soy, coffee, tea, toothpaste, and soap. In some aspects, aromatic substances 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. Generally, any aromatic substance or mixture of substances that provides a clear and pleasant, but not overly strong or irritating, olfactory experience can be used.

[0077] A variety of aromatic substances can be used, as long as they can be evenly dispersed in the structural molding material of the nasal plug, or effectively coated on the surface of the structural molding material, and are useful for the training procedure. Typically, multiple different types of aromas are combined in the training procedure to achieve the desired results.

[0078] According to some aspects, when comprising two parts for insertion into individual nostrils, the nasal plug may include different aromatic substances on each side, such that each nostril is exposed to a different aromatic substance. In other aspects, when comprising two parts for insertion into individual nostrils, the nasal plug may include different concentrations of a specific aromatic substance on each side, such that each nostril is exposed to a different amount of aromatic substance.

[0079] According to some sources, adding aromatic substances to structural molding materials at dose concentrations within the range of aroma-dependent or odor-dependent intervals is sufficient to produce a distinct odor.

[0080] Therefore, the amount and / or concentration of added aromatic substances are important for achieving nasal congestion that can be used for a longer period of time and for allowing the subject to experience the fragrance at an appropriate odor intensity level. The actual concentration of the substance can vary depending on the aromatic substance used and / or the desired odor.

[0081] According to some aspects, the structural molding material is made of thermoplastic elastomer and is uniformly dispersed therein as an aromatic substance or mixture of substances for olfactory experience.

[0082] Therefore, aromatic substances or mixtures of substances that provide an olfactory experience can be alternatively dispersed in structural molding materials.

[0083] According to some aspects, the structural molding material is coated with a coating that includes aromatic substances or mixtures of substances that provide an odor experience.

[0084] As another alternative, structural molding materials may be coated with aromatic substances or mixtures of substances that provide an odor experience, or coated with a composition comprising aromatic substances or mixtures of substances that provide an odor experience.

[0085] The effects and characteristics of the nasal congestion described herein are largely similar to those described above in combination of methods, computer programs, and kits. Aspects mentioned in relation to the disclosed nasal congestion are largely compatible with the kits and methods described herein.

[0086] This disclosure will become apparent from the detailed description given below. The detailed description and specific examples disclose preferred embodiments of this disclosure by way of illustration only. Those skilled in the art will understand from the guidance in the detailed description that changes and modifications can be made within the scope of this disclosure.

[0087] Therefore, it should be understood that the disclosure herein is not limited to the specific components of the described device or the steps of the described method, as such devices and methods can vary. It should also be understood that the terminology used herein is for describing particular embodiments only and is not intended to be limiting. It should be noted that, as used in the specification and appended claims, the terms “a,” “an,” “the,” and “the” are intended to indicate the presence of one or more elements, unless the context clearly specifies otherwise. Thus, for example, references to “device” or “the device” can include several devices, etc. Furthermore, the words “comprising,” “including,” “containing,” and similar terms do not exclude other elements or steps. Attached Figure Description

[0088] The foregoing objects, additional objects, features, and advantages of this disclosure will be more fully understood by referring to the following illustrative and non-limiting detailed description of exemplary embodiments of this disclosure when taken in conjunction with the accompanying drawings.

[0089] Figure 1 One side of the nasal congestion is shown in perspective;

[0090] Figure 2 As shown above Figure 1 Nasal congestion;

[0091] Figure 3 Showing along Figure 2 The section of AA in the middle;

[0092] Figure 4 Showing along Figure 2 The cross-section of BB in the middle;

[0093] Figure 5 A nasal plug molded using 2K technology was showcased;

[0094] Figure 6 This illustrates one aspect of nasal congestion;

[0095] Figure 7 The spiral aspect of the nasal plug is shown in perspective;

[0096] Figure 8 The spiral aspect of the nasal plug is shown as viewed from above;

[0097] Figure 9a and Figure 9b Two perspective views showing another side of the nasal plug; and

[0098] Figure 10 and Figure 10b Two perspective views of another side of the nasal plug are shown.

[0099] Figure 11 It demonstrates nasal plugs and how they can be placed in a user's nostrils.

[0100] Figure 12 A graph is drawn showing the improvement in odor perception using the methods of this disclosure compared to standard care.

[0101] Figure 13 This demonstrates user compliance when using the methods, kits, and nasal packing disclosed herein, compared to standard care. Detailed Implementation

[0102] This disclosure will now be described with reference to the accompanying drawings, in which preferred exemplary embodiments of the disclosure are illustrated. However, this disclosure may be embodied in other forms and should not be construed as limiting it to the embodiments disclosed herein. The disclosed embodiments are provided to fully convey the scope of this disclosure to those skilled in the art.

[0103] The term "aromatic substance" as used in this article refers to both individual aromatic substances and mixtures of aromatic substances that are collectively experienced as odors. Furthermore, odor and aroma are used interchangeably, and both are intended to signify a specific olfactory sensation.

[0104] Olfactory training methods

[0105] One aspect of this disclosure provides a method for olfactory training, comprising the following steps:

[0106] a. Providing an object with at least two or more nasal plugs suitable for insertion into the nostrils of a human object, the nasal plugs comprising a structural molding material and an aromatic substance or mixture thereof that serves as a common odor experience, the aromatic substance or mixture thereof being uniformly dispersed in the structural molding material, and each of the two or more nasal plugs comprising a different aromatic substance or mixture thereof that serves as a common odor experience.

[0107] b. Exposing at least one nostril of the object to two or more nasal plugs one at a time in a predetermined order and duration;

[0108] c. Repeat the exposure daily during the predetermined training period.

[0109] For olfactory training programs to be successful, they must typically be planned and structured in a manner appropriate to the individual subject's needs and the severity of their olfactory loss. Therefore, depending on whether the subject experiences partial or complete olfactory loss, and whether the cause of the loss is a medical condition, the training program can be modified to meet the subject's needs. Furthermore, it is important to motivate the subject to complete the training program, which is often a problem in training programs lasting longer periods. In addition, training programs often require frequent (e.g., daily) training sessions, most often at specific times of day, which must be dedicated to training and can be difficult to maintain in line with the subject's other daily routines and lifestyle. Therefore, one of the main advantages of the solution disclosed herein is that the use of nasal plugs and a training-designed nasal plug kit facilitates such training by lowering the threshold for continuing and completing the training program over time. Furthermore, the nasal plugs designed according to this disclosure are suitable for training because exposure to aromatic substances is effective and easy to use.

[0110] According to another aspect, the step of exposing the nostrils to a nasal plug includes the action of applying the nasal plug to the nostrils by inserting the nasal plug at least partially into the nostrils. Figure 11 An example of a nasal plug 1 is shown, along with how it can be placed into a user's nostril. The left side of the figure shows a side sectional view of the nose with the nasal plug inserted, and the right side shows a front sectional view of the nose with the nasal plug inserted. Preferably, the nasal plug is inserted into the lower portion of the nasal cavity approximately 15mm-20mm using the hand.

[0111] In a further aspect, the step of exposing the nostrils to the nasal congestion includes allowing the nasal congestion to remain in the nostrils for at least about 5 minutes, more preferably about 10 minutes.

[0112] In some cases, exposure to the nostrils involves allowing nasal plugs to remain in the nostrils for approximately 10, 15, 20, 25, or 30 minutes. In most cases, the optimal exposure time for each aroma or mixture of substances as an odor experience is 10 to 15 minutes.

[0113] In some respects, the order in which the subject is exposed to aromatic substances or mixtures of substances as odor experiences varies daily, according to a predetermined plan. Therefore, improved olfactory training can be achieved by varying the subject's exposure to aromatic substances or mixtures of substances as odor experiences.

[0114] In some respects, it includes, in a predetermined order, at least two different nasal plugs having different aromatic substances or mixtures of substances as odor experiences.

[0115] In some respects, the predetermined sequence is that on day 1, the subject is exposed to at least four different aromatic substances or mixtures of substances as odor experiences, and on day 2, the subject is exposed to at least one other aromatic substance or mixture of substances as odor experiences compared to day 1. This principle can be extended to a longer period, such as more than 10 consecutive training days, so that training procedures, for example, including training with 10 different aromatic substances or mixtures of substances as odor experiences, can be varied, allowing the order in which the subject is exposed to aromatic substances or mixtures of substances as odor experiences during daily training to be repeated on a 10-day basis.

[0116] In some respects, the training program lasts for at least one or two weeks, one month, or at least two to four months, and sometimes even longer, such as six to twelve months.

[0117] In some respects, subjects were exposed to aromatic substances or mixtures of substances as odor experiences five days a week, and subjects suspended training two days a week.

[0118] In some aspects, the planned training period is approximately 8 weeks in total. In some aspects, patients are exposed to four different odors daily for a cumulative total of 40 minutes. This exposure is preferably divided into four 10-minute sessions, two in the morning and two in the evening. Each session presents at least one odor different from the previous session, and each session lasts for 10 minutes.

[0119] In a further aspect, the aromatic substances or mixtures of substances used as olfactory experiences are 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.

[0120] In some aspects, exposing the subject's nostrils involves fully inserting at least the entire flexible member into the nostril, leaving only the support member outside. This achieves effective and optimized exposure to aromatic substances, thereby supporting olfactory training.

[0121] In some respects, training is intended to treat hyposmia, anosmia, and / or olfactory inversion. Depending on whether the loss of odor perception is partial or complete, the training program may need to be adjusted.

[0122] In some respects, decreased sense of smell, anosmia, and / or olfactory inversion are the result of an infection, COVID-19, post-COVID-19, head and / or nervous system injury, Parkinson's disease, Alzheimer's disease, stroke, or depression. Therefore, the cause of loss of olfactory sense may vary from person to person, which can sometimes influence the recommended olfactory training program.

[0123] Olfactory training application

[0124] According to another aspect, a computer program is provided for use in olfactory training according to the present disclosure, comprising instructions that, when executed on at least one processor, cause the at least one processor to provide guidance to an object undergoing olfactory training and / or track activities performed by the object in connection with the olfactory training.

[0125] Such a computer program, which may be implemented as a mobile "application" or on a computer or any other user-friendly digital device, will help the subject follow the training procedure in a regular and structured manner and will help track the progress of the training procedure. For example, the "application" may include reminders for the subject related to the selection of timing, duration, aroma, and / or nasal congestion to facilitate the continuation and completion of the training procedure. Furthermore, the "application" may display progress reports to the user. The "application" may also include functionality related to following the experienced development and results, such as requiring the subject to provide information about the experienced development of olfactory training, and based on this feedback from the subject, adjusting the frequency, dosage, aroma exposure, duration, etc., of the training procedure. In addition, the "application" may include functionality for sharing data with doctors or other parties for the purpose of collecting data and / or providing further feedback, and / or developing improved methods and kits.

[0126] Nasal plug kit

[0127] Another aspect of this disclosure illustrates a nasal plug kit for use in an olfactory training procedure according to the method for olfactory training disclosed herein. The kit includes...

[0128] - At least two or more nasal plugs for two or more aromatic substances or mixtures of substances experienced as gases, each nasal plug comprising one aromatic substance or mixture of substances experienced as an odor, and

[0129] - Instructions for use.

[0130] A nasal plug kit is designed to include at least two or more different nasal plugs, each type of which includes an aromatic substance or mixture of substances for olfactory experience, such that the kit includes the necessary aromatic substance or mixture of substances for olfactory experience to perform a given olfactory training procedure. This olfactory training procedure can vary between subjects and according to the subject's needs. For example, a training procedure designed to restore olfactory sensitivity due to partial or complete loss of olfactory sensation can vary in its training design regarding the number and type of aromas to be included and regarding the duration of the training procedure, and therefore the contents of the kit used for the training procedure can vary accordingly.

[0131] In some respects, the kit includes at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 or even more different nasal plugs, which have different aromatic substances or mixtures of substances for olfactory experience.

[0132] Furthermore, depending on the individual's needs, such as the severity of odor loss, it may be beneficial to provide nasal plugs with different concentrations and / or amounts of aromatic substances. Therefore, kits may include nasal plugs with different concentrations or amounts, such as low, medium and / or high concentrations / amounts.

[0133] In some respects, the kit includes nasal plugs for about 10 different aromatic substances or mixtures of substances for olfactory experience, thus providing a kit that can be used for a wide range of training programs including several different types of aromatic substances. For example, a kit suitable for the example training program in Table 1 would include nasal plugs for 10 different aromatic substances or mixtures of substances for olfactory experience, wherein the nasal plugs of the kit should be able to be used with sufficient efficiency over a period of time, for example, 4 months. In this case, the kit may need to include multiple nasal plugs for each aromatic substance or mixture of substances for olfactory experience, so as to address any malfunctions of individual nasal plugs. For example, the kit may include 2 nasal plugs for each aromatic substance or mixture of substances for olfactory experience, thus including a total of 2 × 10 nasal plugs for the training program according to Table 1. In other respects, the kit may include only one nasal plug of each type for each aromatic substance or mixture of substances for olfactory experience, with the intention that the user reuses each nasal plug over several periods of time.

[0134] In some respects, the kit includes multiple nasal plugs for each aromatic substance or mixture of substances used as an odor experience, allowing for the replacement of any nasal plug containing an aromatic substance or mixture of substances as an odor experience due to loss of the aromatic substance's effect or functional loss of the nasal plug (such as mechanical failure). Thus, a kit is provided to facilitate the completion of an olfactory training program that typically lasts several months, improving the likelihood that the subject will successfully regain full or maximum odor perception.

[0135] Nasal congestion

[0136] The nasal plug disclosed herein for use in olfactory training procedures is suitable for insertion into the nostrils of a human subject. The nasal plug comprises a structurally molded material and an aromatic substance or mixture thereof serving as an olfactory experience, said aromatic substance or mixture being uniformly dispersed within the structurally molded material. The term "structurally molded material" means that the nasal plug has a structurally molded shape or plug portion suitable for insertion into the nostril.

[0137] The structural molding material is preferably made of one or a combination of any moldable materials suitable for the nostrils. Examples include plastic materials, various polymers or cellulose-based 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), polyetheretherketone (PEEK), polyacetal (PLA) plastics or polyhydroxyalkanoate (PHA) plastics, pulp or molded cellulose fiber pulp.

[0138] like Figures 1 to 8 As shown, a preferred aspect of the invention illustrates a nasal plug for an olfactory training procedure, comprising:

[0139] -At least one flexible member 2, and

[0140] - A rigid, slender support member 3

[0141] -The flexible members are arranged to surround the supporting members, and

[0142] - A flexible member is adapted to be placed inside the nostril to accurately fill the nostril opening and is provided with means for guiding airflow into the nostril in a serpentine or spiral path through multiple plates or belts, characterized in that the flexible member includes at least one aromatic substance.

[0143] The term "nasal plug" as used in this application is not an obstruction that completely closes the nostrils. While the flexible member fills the nostrils, thereby preventing air from flowing directly into the nose, it is not intended to prevent air from entering. In fact, for many users, the disclosed nasal plug can actually enhance the ease of airflow into and out of the nose because the configuration of the flexible member, when placed in the nostrils, can slightly widen the nostrils and / or support a more open shape. By allowing air to flow through the tortuous structure, and thus travel a longer distance than without a nasal plug, the user of the disclosed nasal plug experiences an improved perception of any aromatic substances included in the nasal plug.

[0144] On the other hand, such as Figure 10a , Figure 1 b、 Figure 11 a and Figure 11 As shown in b, nasal congestion includes:

[0145] Slender support members (2, 62), and

[0146] One or two circular retainer members (3, 63) are each disposed at a corresponding end of the elongated support member (2, 62), wherein the retainer member (3, 63) is adapted to be inserted into the nostril, wherein the distal end points toward the nostril and the proximal end is adjacent to the nostril opening.

[0147] Each of the retainer members (3, 63) includes a bell-shaped cross-section in at least one plane in the distal-proximal extension.

[0148] Each of the retainer components (3, 63) includes:

[0149] The far part of the circle (5), and

[0150] The open proximal portion (7) includes an outer edge (8, 68) circumferentially disposed around the outer periphery of the proximal portion (7) and extending radially outward from the retainer member (3, 63), and

[0151] A middle waist portion (9) is arranged between the distal portion (5) and the proximal portion (7), the middle portion (9) having at least one outer circumference in a plane substantially transverse to the distal-proximal direction, the outer circumference being smaller than the corresponding maximum outer circumference of at least the distal portion (5).

[0152] When the nasal device is disposed in the nostril, the outer edge (8, 68) circumferentially disposed around the proximal portion (7) is adapted to engage with the nostril opening and protrude outward from the nostril.

[0153] The circular distal portion (5) is provided with one or more through holes (6, 66) adapted to allow air to pass through the distal portion (6).

[0154] At least the retainer components (3, 63) include at least one aromatic substance or mixture of substances uniformly dispersed in the structural molding material as an odor experience.

[0155] The aromatic substance is preferably uniformly dispersed throughout the structural molding material or coated on its entire surface.

[0156] A material suitable for use as a structural molding material and optionally as a support member in a nasal plug according to the present disclosure can be prepared by mixing 3 parts of an aromatic substance and 97 parts of a thermoelastic polymer to provide a thermoelastic polymer containing ~3% aromatic substance. Another suitable material can be prepared by mixing 7 parts of an aromatic substance and 93 parts of a thermoelastic polymer to provide a thermoelastic polymer containing ~7% aromatic substance. In some aspects, the structural molding material can be made of a thermoplastic elastomer and an aromatic substance, wherein the aromatic substance constitutes a percentage of the total material in the structural molding material in the range of 2% to 20%, or more preferably 3% to 10%. In some aspects, the aromatic substance constitutes approximately 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.

[0157] Aromatic substances can also be incorporated into or added to the structural molding material of the nasal plug in a slow-release manner, so that the release of the aromatic substances is distributed over time to extend the life of the nasal plug, and / or the release is increased or decreased over time to adapt to the training program of the subject. For example, the aromatic substances can be uniformly dispersed throughout the molded nasal plug and then gradually diffuse out of the nasal plug material over a period of time.

[0158] The concentration and / or amount of each aromatic substance in the structural molding material of the nasal plug should reach a level such that the odor of the aromatic substance in the nasal plug can be clearly identified when exposed to the nostrils of a subject experiencing odor loss. Furthermore, the odor of the aromatic substance should not reach a level that would be unpleasant and / or annoying to the subject. Therefore, depending on the severity of the subject's odor loss, each subject may require different individual concentrations / amounts. Thus, in some respects, nasal plugs can be provided, for example, with low, medium, and high concentrations and / or amounts of aromatic substances, allowing for the selection of appropriate concentration levels and / or amounts for a specific subject.

[0159] Figure 1 A nasal plug 1 is shown, comprising a set of flexible members 2 including aromatic substances and a rigid, elongated support member 3 adapted to stabilize the flexible members. In this aspect of the nasal plug, the set of flexible members 2 includes parallel plates 4 surrounding the support member. Spaces 5 exist between adjacent plates. Furthermore, these spaces communicate with each other via the plates. When the nasal plug is placed in the nose and the flexible plates accurately fill the openings of the nostrils, air entering the nostrils first enters through a recess 7 in the lowermost first plate as it passes through the nasal plug. The airflow then passes through the nasal plug in a tortuous manner and exits through a recess 6 in the uppermost final plate. The exited air flows in the opposite direction. Therefore, when inhaling and exhaling, the air will travel a longer distance than if no nasal plug were placed in the nostrils and will be exposed to the aromatic substances in both directions.

[0160] Throughout the passage through the nasal plug, air comes into contact with a flexible component containing aromatic substances. This aspect demonstrates a significantly extended path for airflow because each second recess is located at the periphery, opposite a recess on the adjacent plate in terms of lateral diameter. Figure 4 The recess 7 of the first plate and the recess 6 of the final plate, as well as all the recesses in between, are clearly visible. Specifically, the recess 7 of the bottommost first plate and the recesses of each second plate counted from the first plate have the same reference mark, and the recess 6 of the topmost final plate and the recesses of each second plate counted from the final plate have the same reference mark. When the number of plates is even (e.g., ...), Figures 1 to 6 (As shown), this is valid; otherwise, if the number of plates is not even, the recesses of the first and final plates will have the same reference markings.

[0161] exist Figures 1 to 6The nasal plug shown includes a set of flexible members 2 containing aromatic substances, adapted to guide airflow into the nostrils in a serpentine or meandering path. This is achieved when the nasal plug is placed in the nostrils. Airflow enters the nasal plug 1 through the recess 7 of the lowest plate 4, then passes through the space 5 between two adjacent plates (i.e., the first and second plates), reaching the opposite lateral diameter end of the first plate, where it is further guided through the recess 6 of the second plate. Thereafter, airflow passes between two more adjacent plates, i.e., the second and third plates, reaching the opposite lateral diameter end of the second plate, where it is further guided through the recess 7 of the third plate. This continues until airflow passes between the two highest plates and exits into the nostrils through the recess 6 of the final plate.

[0162] exist Figures 1 to 4 The aspects shown include 6 boards, and... Figure 5 and Figure 6 In this configuration, the number of boards is 8. The number of boards can also be other numbers, such as 7, 9, or 10. The number of boards is preferably in the range of 4 to 12.

[0163] Figure 2 As shown above Figure 1 The nasal congestion is shown in the diagram. As can be seen, plate 4 has an elliptical shape. The topmost plate is the smallest (both lateral and conjugate diameters), and the middle plates, numbered four and / or five, are the largest. The first plate is slightly larger than the final plate. From the first plate, each further adjacent plate has a slightly larger diameter, up to the fourth or fifth plate, and thereafter each further adjacent plate has a slightly smaller diameter; that is, from the first plate to the fourth or fifth plate, the lateral and conjugate diameters of each plate increase, and from the fourth or fifth plate to the final plate, the lateral and conjugate diameters of each plate decrease. The increase or decrease of each adjacent plate can be linear, but it can also proceed irregularly.

[0164] exist Figure 2 The figure shows lines AA and BB. Line AA coincides with the conjugate diameter of the plate, and line BB coincides with the transverse diameter of the plate.

[0165] The flexible component 2 includes an aromatic substance. The aromatic substance may be incorporated into the material constituting the flexible component 2, for example, by being uniformly dispersed within the material. The aromatic substance may also be coated onto the flexible component 2, as is known in the art.

[0166] The flexible member 2 is preferably made of a thermoplastic elastomer or other suitable polymer, wherein the aromatic substance is uniformly dispersed throughout the thermoplastic elastomer using any suitable manufacturing technique. In one aspect, the aromatic substance can be introduced into the thermoplastic elastomer or other suitable flexible material using an additive masterbatch method. Alternatively, the aromatic substance can be introduced by coating the flexible member, and in some aspects also the support member, with an aromatic substance in a suitable solution or by dispersing it into the thermoplastic elastomer or other suitable material. Therefore, the flexible member 2 can be made of a thermoplastic elastomer with an aromatic substance coated on its surface.

[0167] Other flexible materials can be used for the flexible and / or support components. Support components are preferably made of thermoplastic polymers. Other strong or rigid materials may also be used. In some aspects, the support and / or flexible components may also include one or more reinforcing members, such as a core of a more rigid and / or formable material, so that portions of the nasal plug can be less flexible and / or the support component can be compressed into a shape that better fits an individual's nose or nostrils.

[0168] exist Figure 3 The figure shows a cross-sectional view along AA. In this figure, a set of flexible members 2 are integrally formed with the corresponding ends of the support member 3, and the flexible members 2 surround the ends of the support member 3. The support member 3 has a generally U-shaped shape and has two sets of flexible members 2 attached thereto, one set at each end. The support member 3 extending between the two ends has a curved shape for easy gripping.

[0169] Figure 4 The diagram shows a cross-sectional view along BB. This section corresponds to the transverse diameter of plate 4. Therefore, the recess 6 of each second plate is shown on one side, while the recess 7 of each other second plate is shown on the other side.

[0170] like Figure 5 As described, the two legs of the generally U-shaped support member 3 can be slightly tilted and / or angled relative to each other. This facilitates the adaptation and arrangement of the nasal plug to the extension of the nostrils. The nasal plug should be properly positioned inside the nose without excessively enlarging the nostrils.

[0171] The nasal plug according to this disclosure can be manufactured using 2K molding technology, in which two materials are molded together. Therefore, a support member can be first molded with one material, and then a flexible member can be directly molded onto the support member using the same or a different material. This... Figures 5 to 7 This is shown in the image. The same applies to the combination below. Figure 10a , Figure 10b , Figure 11 a and Figure 11The nasal plug described in b. Methods of manufacturing the nasal plug may also include other techniques, such as extrusion molding, injection molding, casting, compression molding, transfer molding, or any other suitable technique for the material used. In some aspects, the entire nasal plug may be manufactured using only one material, i.e., the material used for the flexible member or retainer member is the same as the material used for the support member. The aromatic substance is then dispersed throughout the nasal plug. Furthermore, the flexible member or retainer member and support member included in the nasal plug according to this disclosure can be manufactured by molding them separately using the same material or two different materials, and then assembling the two parts together. In such cases, the amount of aromatic substance can be adapted to different parts of the nasal plug. For example, one part may include an aromatic substance or an aromatic mixture, and another part may be without aromatic substance. In another example, different parts of the nasal plug may have different concentrations of aromatic substance, different types of aromatic substance, or different aromatic mixtures.

[0172] This disclosure supports the conclusion that, without causing airflow suppression, the combination of air guided through a longer path with aromatic substances incorporated into the nasal plug material and thus onto all surfaces along this path produces a highly effective, comfortable, and easy-to-use nasal plug for improving the training of olfactory sensitivity in subjects experiencing partial or complete loss of odor perception. More specifically, as previously described, the arrangement of the flexible components of the nasal plug allows air to be guided through a longer path than in a nostril without a plug, while maintaining ease of breathing for the user. When the arrangement of the flexible components is combined with the aromatic substances incorporated into the material, a significant odor training effect is achieved in the subject.

[0173] This disclosure further points out the long-term effects, concluding that the nasal plugs disclosed herein can be worn by the user for at least 8 hours and / or repeated for shorter periods over longer periods (up to 2, 3, 4, 5, 6 months or even longer) while still maintaining the effectiveness of experiencing the aroma of the aromatic substances.

[0174] Figure 6 One aspect is shown, in which each nasal plug includes a flexible member disposed on a support member, suitable for individual placement in a nostril.

[0175] Figure 7 One aspect of a flexible member is shown in perspective, comprising a helically arranged band. This helical structure provides an extended path for air to enter the nostrils. The distance of the path can vary due to the pitch angle of the helical blades of the band. Recesses can also be provided on the helically arranged band. However, since they allow air to enter without recesses, they are not a fundamental feature.

[0176] exist Figure 8 In the middle, seen from above Figure 7 In terms of the middle. Figure 7 and Figure 8 The spiral arrangement shown illustrates a flexible component adapted to guide airflow into the nostrils in a spiral path.

[0177] Figure 10a and Figure 10b A different perspective view of another side of the nasal plug is shown, and Figure 11 a and Figure 11 b shows a different perspective view of another aspect of the nasal plug. Regarding the material, at least one aromatic substance or mixture of substances, as a odor experience, is uniformly dispersed in the structural molding material and possible manufacturing techniques; these aspects have the same characteristics as those described above.

[0178] Figure 10a , Figure 10b , Figure 11 a and Figure 11 The nasal plug of device b comprises semi-rigid, elongated support members 2, 62. At both ends of the support members 2, 62, two circular retainer members 3, 63 are provided, wherein the distal end 4 of each circular retainer member is adapted for distal insertion into the corresponding nostril. The shape of the retainer members provides a central waist portion 9 suitable for "suspending" in the nostril opening, wherein a wider distal portion 5 and a wider proximal portion 7 provide a secure fit to the nostril opening. Outer edges 8, 68 are circumferentially disposed around the outer periphery of the proximal portion 7 and are adapted to engage with the nostril opening and protrude outward from the nostril when the nasal device is disposed in the nostril.

[0179] The circular distal portion 5 is provided with one or more through holes 6, 66, which are adapted to allow air to pass through the retainer members 3, 63. In these aspects of the nasal plug, at least the retainer members 3, 63 include at least one aromatic substance or mixture of substances as an odor, uniformly dispersed in the structural molding material.

[0180] The aspects and embodiments mentioned and described above are given by way of example only and should not be limited to the present invention. Other solutions, uses, purposes, and functions within the scope of the present invention claimed in the appended claims should be apparent to those skilled in the art.

[0181] Those skilled in the art will recognize that this disclosure is not limited to the preferred embodiments described above. They will further recognize that modifications and variations can be made within the scope of the appended claims. Furthermore, through a study of the drawings, this disclosure, and the appended claims, those skilled in the art can understand and implement variations to the disclosed embodiments in practicing the claimed disclosure.

[0182] Example

[0183] Example 1 – Olfactory Training Program

[0184] A suitable training program (see Table 1) involves, for example, exposing the subject once or twice daily (e.g., in the morning and / or evening) to four different aromatic substances or mixtures of substances as an olfactory experience, each for approximately 10 minutes. Typically, this training program can last for about four months. Furthermore, the aromatic substances the subject is exposed to can vary daily. For example, if the subject is exposed to aromatic substances 1, 2, 3, and 4 on day 1, then on day 2, they could be exposed to aromatic substances 2, 3, 4, and 5, and so on. After 10 days, the training program cycle is repeated.

[0185]

[0186] Example 2 – Nasal Congestion Kit

[0187] The nasal plug kit used in the olfactory training program for Example 1 can be designed as follows:

[0188]

[0189] Another example is a kit with 10 different fragrances, each with 16 nose plugs. For instance, these ten different fragrances could be strawberry, vanilla, lemon, melon, rosemary, menthol, cherry, orange, cola, and lavender. In other cases, one or more fragrances may be replaced, one or more fragrances may be removed from the list above, and / or further incorporated into one or more of peach, banana, apple, clove, and other fragrances listed herein.

[0190] Example 3 – Mobile device application for olfactory training

[0191] Applications for olfactory training may have one or more of the following:

[0192] • For scheduling and reminder purposes: Provide users with a structured calendar to organize their olfactory training sessions and provide reminders, thereby cultivating a consistent routine.

[0193] • For visualization purposes: Use images to enhance user experience and engagement during training sessions.

[0194] • For feedback purposes: Allow users to record their subjective feedback on their sense of smell, quality of life, and progress over time for personal reflection and self-awareness.

[0195] Example 4 – A study on olfactory training methods using nasal plugs

[0196] One hundred and sixteen participants aged 18–65 years with olfactory impairment (95 women and 21 men) were enrolled in a randomized controlled trial and randomly assigned to two different treatment statuses (https: / / classic.clinicaltrials.gov / ct2 / show / NCT06142565). The study was approved by the Swedish Ethics Review Board (Dnr:2023-03779-01), and all participants provided written informed consent before participation. All procedures complied with the Declaration of Helsinki. The two groups were similar in age, sex, duration of olfactory dysfunction, and baseline olfactory measurement scores (Table 1). Inclusion criteria were functional olfactory impairment at baseline, defined as a TDI between 16.5 and 30.5 (defined below), and age between 18 and 65 years. Exclusion criteria were mental or nonviral or non-idiopathic causes of olfactory dysfunction (e.g., head trauma, surgery), and current enrollment in any other olfactory training studies.

[0197]

[0198] At the initial visit, participants had experienced olfactory dysfunction for an average of 41 months. The second visit was conducted on average two months after the first visit. During the first visit, participants were randomly assigned to one of two olfactory training groups. Apart from specific types of olfactory training, both groups received seemingly identical treatments and protocols throughout the study.

[0199] One group underwent passive olfactory training using scented nasal plugs as described in this paper, while the other group underwent standard care olfactory training using scents found in their own homes. Training was conducted at home during weekdays for two consecutive months, or eight weeks. Standard clinical practice recommended by the Swedish healthcare system typically involves a 12-week training program, but because the primary objective of this study was to address adherence issues, the training was limited to eight weeks. Training was conducted only during weekdays, not daily. These adjustments were made to avoid excessive dropout, as informal observations in clinics indicated a patient dropout rate of approximately 80%.

[0200] More specifically, participants randomly assigned to the nasal plug olfactory training (PT) group were provided with scented nasal plugs as 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 8 weeks. Figure 11The demonstration involved inserting nasal plugs, each releasing a specific scent (vanilla, lemon, melon, rosemary, menthol, orange, peach, strawberry, cherry, or cola) while still allowing near-normal airflow through the nostrils. Participants were instructed to use one scented plug for 10 minutes, then replace it with another scented plug for the remaining 10 minutes of the session. They were further instructed to visualize and focus on the scent during training, aided by images of the scented object printed on the individual nasal plug packaging. During the eight-week home training period, all participants were contacted twice with information on where to reach them if they had any questions, comments, or concerns. Text messages were sent one week after the initial period, and phone calls were made approximately three weeks later.

[0201] Participants assigned to the Standard Care Olfactory Training (ST) group were instructed to choose 4–6 household scents, each weekday, for 20 minutes in the morning and 20 minutes in the evening, for 8 weeks. Participants were instructed to smell each item for 10–20 seconds and to visualize and focus on the scent during the training. Similar to the PT group, all participants were contacted twice during the 8-week home training period to inform them where to contact them if they had any questions, comments, or concerns. Text messages were sent one week after the initial period, and phone calls were made approximately three weeks later. Upon completion of the study, ST group participants were asked to take home the same olfactory training kit provided to the PT group.

[0202] Subjective and objective indicators of olfactory problems, as well as subjective indicators related to quality of life and overall health, were assessed before and after treatment. The assessed indicators included:

[0203] • Objective olfactory function was tested using a standardized Sniffin's Sticks extended test cell (Burghart Messitechnik, Holm, Germany). Objective olfactory function was assessed before and after 8 weeks of odor training. A pen-like tool was used to present odors and evaluate the performance of the nasal chemiluminescence sensory system in terms of odor detection threshold (T), odor quality discrimination (D), and cue odor recognition (I). These were combined to generate a summary TDI score, reflecting overall olfactory performance, with higher scores indicating better performance.

[0204] • Subjective olfactory function is self-assessed using a 10-point visual analog scale (VAS), ranging from 0 (no odor perception) to 10 (excellent odor perception).

[0205] • Adherence, including dropout rate and persistence, was assessed using questions asking participants about their experience during olfactory training, specifically regarding their adherence, such as how frequently they actually completed olfactory training and how frequently they forgot to complete it. Dropout rate was defined as the percentage of individuals in the corresponding group who did not complete the final test period. This was obtained by counting the total number of participants who decided to discontinue participation at any point before the second visit, either notifying the experiment coordinator or ending communication without explanation. A six-item questionnaire on treatment persistence (Haas et al., 2024) individually assessed consistency, feeling bored, forgetfulness, and possible reasons for discontinuing training. The questionnaire was given to participants during the second visit.

[0206] Statistical analysis was performed using the statistical software R (v4.3.3; R Core Team 2024). The significance criterion for statistical tests was set at α = 0.05. The research hypotheses, inclusion / exclusion criteria, and analysis plan were pre-registered on clinicaltrials.gov, ID NCT06142565.

[0207] The research results show that, Figure 12 As shown, there was a nominal improvement in objective olfactory function. On average, trained individuals improved their olfactory function by 3.5 scale steps, while patients in the standard care group improved their olfactory function by 1.8 scale steps (measured on a relative scale of 16 to 42). Both values ​​indicate statistically significant improvements and correspond to subjective assessments of treatment.

[0208] In addition, regarding compliance, such as Figure 13 As shown, compared with participants who used standard nursing training (23.2%), Figure 13 Compared to participants using nasal plugs (described as "standard care" in the figure), far fewer participants (6.7%) dropped out of the training. Figure 13 The results showed how many participants forgot to perform daily training (frequently, occasionally, rarely, or never). Furthermore, among the participants who completed the training, a significantly greater number performed the training regularly, as evidenced by the large proportion of those who never forgot to perform daily training (38.3% in the nasal congestion group and 10.7% in the standard care group).

[0209] In summary, compared to standard care methods, the nasal plugs and olfactory training methods disclosed herein demonstrated significantly improved results in both olfactory function and adherence. Therefore, the methods, kits, and nasal plugs disclosed herein provide improved outcomes for olfactory training for those in need. Furthermore, when asked about their experience, participants indicated that using the nasal plugs described herein was easier than standard care methods, and they were more willing to follow the treatment because it was easier to integrate into daily life. Using the nasal plugs allows users to perform their daily tasks while conducting olfactory training. This is positive for both individuals and society as a whole, with lower healthcare costs.

Claims

1. A method for olfactory training, comprising the following steps: a. Providing an object with at least two or more nasal plugs suitable for insertion into the nostrils of a human object, the nasal plugs comprising a structural molding material and an aromatic substance or mixture thereof that serves as a common odor experience, the aromatic substance or mixture thereof being uniformly dispersed in the structural molding material, and each of the two or more nasal plugs comprising a different aromatic substance or mixture thereof that serves as a common odor experience. b. Exposing at least one nostril of the object to the two or more nasal plugs one at a time in a predetermined order and duration; c. Repeat the exposure daily during the predetermined training period.

2. The method for olfactory training according to claim 1, wherein, Exposing the nostrils to a nasal plug includes the act of applying the nasal plug to the nostrils by inserting the nasal plug at least partially into the nostrils.

3. The method for olfactory training according to any of the preceding claims, wherein, 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.

4. The method for olfactory training according to any of the preceding claims, wherein, The order in which the object is exposed to the aromatic substances or mixtures of substances as an olfactory experience varies daily according to a predetermined schedule.

5. The method for olfactory training according to any of the preceding claims, wherein, Use at least two different nasal plugs, each containing a different aromatic substance or mixture of substances, in the predetermined order, to provide an olfactory experience.

6. The method for olfactory training according to any of the preceding claims, wherein, The predetermined sequence is as follows: on day 1, the subject is exposed to at least four different aromatic substances or mixtures of substances as an odor experience, and on day 2, the subject is exposed to at least one other aromatic substance or mixture of substances as an odor experience compared to day 1.

7. The method for olfactory training according to any of the preceding claims, wherein, The duration of the training program is at least 1 to 2 weeks, preferably at least 1 month, and more preferably at least 2 to 4 months, wherein the subject is exposed to the aromatic substance for 5 days per week and the subject pauses the training for 2 days per week.

8. The method for olfactory training according to any of the preceding claims, wherein, Exposing at least one nostril involves fully inserting at least the entire flexible member into the nostril, such that only the support member remains outside the nostril.

9. The method for olfactory training according to any of the preceding claims, wherein, The aromatic substances or mixtures of substances used as an olfactory experience are 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.

10. The method for olfactory training according to any of the preceding claims, wherein, The training is intended to treat hyposmia, anosmia, and / or olfactory inversion.

11. The method for olfactory training according to claim 10, wherein, The aforementioned decreased sense of smell, loss of smell, and / or olfactory inversion are the result of the subject having or currently having an infection, COVID-19, post-COVID-19, head 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 of the preceding claims, the computer program comprising instructions that, when executed on at least one processor, cause the at least one processor to provide guidance to an object undergoing olfactory training according to any of the preceding claims, and / or track activities performed by the object as part of the olfactory training.

13. A nasal plug kit for use in the method for olfactory training according to any one of claims 1 to 11, comprising: - At least two or more nasal plugs for at least two or more different odors, each nasal plug comprising an aromatic substance or mixture of substances for odor experience, and - Instructions for use.

14. The nasal plug kit of claim 13, wherein, The aromatic substances or mixtures of substances used as an olfactory experience are 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.

15. The nasal plug kit according to claim 13 or 14, wherein, The kit includes at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 or 25 different nasal plugs, which have different aromatic substances or mixtures of substances for odor experience.

16. The nasal plug kit according to any one of claims 13 to 15, wherein, The nasal plug contains aromatic substances or mixtures of substances with different concentrations and / or amounts for odor experience, such as low, medium and / or high concentrations / amounts of aromatic substances or mixtures of substances for odor experience.

17. The nasal plug kit according to any one of claims 13 to 16, wherein, The kit includes nasal plugs containing approximately 10 different aromatic substances or mixtures of substances for olfactory experience.

18. The nasal plug kit according to any one of claims 13 to 17, wherein, The kit includes multiple nasal plugs for each aromatic substance or mixture of substances used as an olfactory experience.

19. A nasal plug (1, 10) for use in an olfactory training procedure, said nasal plug being adapted for insertion into the nostril of a human subject. Its features are, The nasal plug comprises a structural molding material and an aromatic substance or mixture thereof that is commonly experienced as an odor, the aromatic substance or mixture thereof being uniformly dispersed in the structural molding material.

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

21. The nasal plug according to claim 19 or 20, further comprising: At least one flexible member (2) and a rigid elongated support member (3), wherein the flexible member is arranged to surround the support member, and The flexible member is adapted to be placed inside the nostril to accurately fill the opening of the nostril, and is provided with means for guiding airflow into the nostril in a serpentine or spiral path through multiple plates or belts. Wherein, at least the flexible component includes at least one aromatic substance or mixture of substances uniformly dispersed in the structural molding material as an odor experience.

22. The nasal plug according to claim 19 or 20, further comprising: Slender support members (12, 62), and One or two circular retainer members (13, 63) are each disposed at a corresponding end of the elongated support member (12, 62), wherein the retainer member (13, 63) is adapted to be inserted into the nostril, wherein the distal end points toward the nostril and the proximal end is adjacent to the opening of the nostril. Each of the retainer members (13, 63) includes a bell-shaped cross-section in at least one plane in the distal-proximal extension. Each of the retainer components (13, 63) includes: The distal part of the circle (15), and An open proximal portion (17) includes an outer edge (18, 68) circumferentially disposed around the outer periphery of the proximal portion (17) and extending radially outward from the retainer member (13, 63), and A middle waist portion (19) is arranged between the distal portion (15) and the proximal portion (17), the middle portion (19) having at least one outer circumference in a plane substantially transverse to the distal-proximal direction, the outer circumference being smaller than the corresponding maximum outer circumference of at least the distal portion (15). When the nasal device is disposed in the nostril, the outer edge (18, 68) circumferentially disposed around the proximal portion (17) is adapted to engage with the opening of the nostril and protrude outward from the nostril. The circular distal portion (15) is provided with one or more through holes (16, 66) adapted to allow air to pass through the distal portion (15). Wherein, at least the retainer components (13, 63) include at least one aromatic substance or mixture of substances uniformly dispersed in the structural molding material as an odor experience.

23. The nasal plug according to any one of claims 19 to 22, wherein the nasal plug is molded as a single piece.

24. The nasal plug according to any one of claims 19 to 23, wherein, The at least one aromatic substance or mixture of substances, which serves as the odor experience, is uniformly dispersed throughout the structural molding material.

25. The nasal plug according to any one of claims 19 to 24, wherein, The at least one aromatic substance or mixture of substances, which serves as an odor experience, 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 dissolution or dispersion 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 substances are 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.

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

29. The nasal plug according to any one of claims 19 to 28, wherein, The structural molding material is made of thermoplastic elastomer and is uniformly dispersed therein as the aromatic substance or mixture of substances for odor experience.

30. The nasal plug according to any one of claims 19 to 29, wherein, The structural molding material is coated with a coating that includes the aromatic substance or mixture of substances as an odor experience.

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