The present invention relates to medical diagnostics tests and, more particularly, to an olfactory impairment testing kit and approach.
Reversible and irreversible olfactory impairment is indicative of multiple physiological or pathological conditions. For example, there are many causes for reversible olfactory impairment including upper respiratory infections, nasal polyps, medications such as antibiotics and blood pressure pills, and mild cognitive impairment. Irreversible olfactory impairment may arise as a consequence of natural aging or pathological conditions, such as dementia and Alzheimer’s disease. Cognitive impairment and olfactory loss are also associated with several autoimmune diseases like rheumatoid arthritis, Sjögren syndrome, multiple sclerosis, and systemic lupus erythematosus. Olfactory function testing has thus been used for assessment of mild cognitive impairment, dementia, Parkinson’s disease and Alzheimer’s disease.
Conventional olfactory testing requires the involvement of a healthcare professional to administer the test and multiple hospital visits, which increases the cost of screening for early assessment of conditions such as cognitive impairment. As a result, olfactory testing is often not used, which can lead to delay in disease diagnosis and the need for more tests such as brain scans.
Accordingly, there is a need in the art for an olfactory testing approach that is less expensive and integration with cognitive self-assessments that can be made available for general use, thereby improving the early detection and diagnosis of cognitive impairments. Early detection and diagnosis of these conditions can provide an opportunity for appropriate treatment and lifestyle changes, such as proper diet, exercise, stress, and stress reduction, that can help restore normal cognition or delay progression of cognitive loss as well as help in development of improved therapies for cognitive impairment. In addition, smell retraining techniques can be used for re-training of the olfactory system after a period of loss of olfactory sensation, such as that associated with viral infections and, more specifically, SARS-CoV-2.
The present invention is a patient directed olfactory testing platform that can be used by individuals to test for reversible and irreversible olfactory loss and to perform olfactory training to help restore a lost sense of smell. The system also relates to a system that integrates olfactory performance with various cognitive domains. More specifically, the present invention comprises an olfactory testing and training platform having a kit with a plurality of scents and an accompanying computer application that can allow an individual to perform olfactory testing and training in a randomized manner and, optionally, perform preliminary diagnosis or screening analyses. The kit contains a plurality of inhaler sticks, each of which includes a first indicia that is computer readable, and a second indicia that is human readable, wherein each of the inhaler sticks provides a scent that is different than every other inhaler stick or similar with varied intensities. The scents can be similar in odor arising from a single chemical agent or a combination of multiple chemical entities (e.g. phenyl ethyl alcohol and rose essence, both smell of rose, one is a single chemical compound, other is a mixture of chemicals, but both generating a common familiar scent). A smart device having a camera and a computer application programmed to identify each inhaler stick in the kit by the first indicia is used to provide the user with a prompt to select a detected scent for a given inhaler stick from a plurality of options in response to presentation of the first indicia of the given inhaler stick to the camera. This method is used to assess odor identification score. The second indica is used to assess odor discrimination and odor intensity/ threshold.
In a first embodiment, the invention may be an olfactory testing platform comprised of a kit containing a plurality of scented objects such as inhaler sticks, each of which includes a first indicia that is computer readable, and a second indicia that is human readable, wherein each of the inhaler sticks provides a scent that is different than at least one other inhaler stick. The invention also includes a computer application configured to run on a smart device having a camera, where the computer application is programmed to identify each inhaler stick in the kit using the first indicia and to prompt a user to select a detected scent from a plurality of options in response to presentation of the first indicia to the camera of the smart device. The first indicia and the second indicia may be positioned on opposing sides of each of the plurality of inhaler sticks. The kit may include a rack having a plurality of receptacles for receiving the plurality of inhaler sticks and a cover that can be positioned in covering relation to the rack to enclose the plurality of inhaler sticks. At least one of the rack and the cover includes a third indicia containing information about the plurality of inhaler sticks. The computer application may be programmed to prompt a user to scan each inhaler stick in the kit using the first indicia. The computer application may be programmed to prompt a user to select more than one of the plurality of inhaler sticks and identify the scent of each of the more than one of the plurality of inhaler sticks. The computer application may be programmed to prompt a user to select at least two of the plurality of inhaler sticks and to discriminate between the at least two of the plurality of inhaler sticks according to a strength of the scent associated with each of the at least two of the plurality of sticks. The computer application may be programmed to prompt a user to scan one of the plurality of inhaler sticks and to display the scent associated with that inhaler stick. The computer application may be programmed to display a digit corresponding to one of a series of symbols in a table and to allow the user to draw the one of the series of symbols corresponding to the digit. The computer application may be programmed to record the eye movements of the user when the user draws the one of the series of symbols corresponding to the digit.
In another embodiment, the invention may be a method of performing olfactory testing. The method involves providing a plurality of scented objects such as inhaler sticks, each of which includes a first indicia that is computer readable, and a second indicia that is human readable, wherein each of the inhaler sticks provides a scent that is different than at least one other inhaler stick and then using a computer application running on a smart device having a camera to identify each inhaler stick in the kit upon presentation of the first indicia to the camera and to prompt a user to select a detected scent from a plurality of options after presentation of the first indicia to the camera. The method may also involve the step of using the computer application to prompt a user to scan each inhaler stick in the kit using the first indicia. The method may also involve the step of using the computer application is programmed to prompt a user to select more than one of the plurality of inhaler sticks and identify the scent of each of the more than one of the plurality of inhaler sticks. The method may also involve step of using the computer application to prompt a user to select at least two of the plurality of inhaler sticks and to discriminate between the at least two of the plurality of inhaler sticks according to a strength of the scent associated with each of the at least two of the plurality of sticks. The method may also involve the step of using the computer application to prompt a user to scan one of the plurality of inhaler sticks and to display the scent associated with that inhaler stick. The method may also involve the step of using the computer application to display a digit corresponding to one of a series of symbols in a table and to allow the user to draw the one of the series of symbols corresponding to the digit. The method may also involve the step of using the computer application to record the eye movements of the user when the user draws the one of the series of symbols corresponding to the digit.
The present invention will be more fully understood and appreciated by reading the following Detailed Description in conjunction with the accompanying drawings, in which:
Referring to the figures, wherein like numerals refer to like parts throughout, there is seen in
Wick 18 may be permeated to provide the ten basic smells that can be used for olfactory testing. These smells are fruity (e.g. mango, peach, melon), citrous/ lemon (e.g. lemon or oranges), floral (rose, chamomile). Mint/peppermint (e.g. menthol, peppermint, eucalyptus and camphor), sweet (e.g. chocolate, vanilla, caramel, and malty scents), toasted/nutty (e.g. peanut butter, popcorn, and almonds), woody/resinous (e.g. pine, fresh cut grass, musty, moldy, heavy, burnt, and smoky), chemical (synthetic smells recognized as danger signals, e.g. alcohols, disinfectants, ammonia, bleach, gasoline, and paint, leather), pungent (e.g. blue cheese, cigarette smoke, fecal matter/manure, sweat, onion, garlic), and putrid (e.g. rotting meat, sewage, burnt rubber, sulphuric acid, and household gas.
The smells provided by wicks 18 can be produced through natural sources, such as essential oils and odor producing chemicals that are generally recognized as safe (GRAS) such as those used for food additives. Essential oils for producing certain smells may include, without limitation, one of more of the following: cinnamon, turpentine, lemon, smoke, ammonia, chocolate, rose, paint thinner, banana, pineapple, gasoline, soap, cloves, orange, coffee, peppermint, peach, cherry chamomile, eucalyptus, wintergreen, thyme, sage, rosemary, garlic, and onion. Other substances such as fish oil or single compound odors including, without limitation, isoamyl acetate (for banana), phenyl ethyl alcohol (for rose), citronellal (for lemon), eugenol (clove), and eucalyptol (for eucalyptus) may be used. Mixtures of odorants may also be used. The essential oils, chemicals or mixtures, are used to wet absorbent wick 18, or may be diluted in vegetable oil or mineral oil as needed, and then applied to absorbent wick 18. Some inhaler stick/s may be wetted with only mineral oil or vegetable oil (no added smells). Some inhaler stick may not be wetted with any smell or odorant at all. Such inhaler sticks will be used if the user identifies the inhaler stick as having low or no smell tone.
Odorants in inhaler sticks 14 can be all unique smells, or some smells in the kit could be repeated odorants at the same or different concentration for use as an assessment of odor intensities and odor discrimination. Inhaler sticks 14 may also be designed to test for the ability to distinguish one smell from two similar smells. Such inhaler sticks 14 may also be used to identify the strongest or the weakest concentration among the options offered in the question.
Referring to
Referring to
Referring to
Referring to
With respect to testing, four different types of odor tests may be self-administered: (1) odor identification that determines the ability to identify a particular odor when presented; (2) test-retest (intra-test consistency) that determines the ability to correctly identify the same smell the same way (same correctly or same smell incorrectly), more than one time. The intra-test consistency routine may be carried out by inducing a level of stress e.g. use of a large visible count-down, flashing light, buzzer or alike (3) odor discrimination that determines the ability to differentiate a particular odor from others; and (4) odor intensity determination that determined the level at which the ability to identify an odor functions.
Referring to
Referring to
Referring to
Referring to
Software application 50 is programmed to collect data during these tests, including a percentage of correct responses, test-retest reliability, average response time, odor discrimination score, and odor intensity discrimination score, smell test scan-to-scan response time as an indicator of executive function, odor specific response, olfactory intra-test consistency, olfactory response under stress. As certain odors arouse distinct memories, olfactory performance is also a measure of episodic memory.
Olfactory test can be performed under a level of stress. Here, a psychological stress can be applied in the form of a count-down clock, flashing light, buzzer or alike. Responses and response time of test without stress and under stress offer a greater level sensitivity for assessment of cognitive and olfactory functions, that may not be possible in a clinical setting.
Referring to
The olfactory test may be adapted to any cultural or regional population with odors familiar to the population.
Software application 50 may additionally be programmed to perform additional testing unrelated to olfactory functionality but related to conditions for which olfactory deterioration is associated. For example, software application 50 may perform a digit-symbol substitution test that is a well-established neuropsychological test sensitive to brain damage, dementia, age and depression. In this test, numerical digits are substituted for certain symbols. Referring to
The test begins with a few practice trials, where a particular digit is displayed in location 208, and the user has to use look up table 200 to identify and then draw the symbol corresponding to the digit, as show in in
Referring to
After three tries, the program may shift to timed tests where a predetermined number of tests are performed. Meta-data is collected during the tests, such as eye movements captured by front camera 204, response times (or average response time), patterns in drawing straight lines/edges/angles/ circles, smoothness of lines between the dots in the grid, roundedness of circles, degree of roundedness in drawing angles, and other applicable patterns. A library of symbols that can be drawn using the 3×3 grid is created. There are four sections in the test session (three rounds of copying task and one round of recall task). Each test session has a unique combination of digits and symbols. This is done to not allow any prior memory. AI-based image processing algorithms may be applied to compare the reference image displayed in the screen with the image created by the user. The user needs to first perform three rounds of copy function where the digits for which the corresponding symbol needs to be copied. In the first round the dots in the 3×3 grid appears dark, in the next round the grid appears fainter and in the third round the grid is invisible, where the user must copy on an empty canvas. The traces offer information on visuo-perceptual response, fine motor skills, attention. After three rounds of copying (a total of copying thirty symbols), the task changes to a recall task, where the symbols disappear. The performance in the recall section of the routine provides information about user’s non-verbal memory. In a sense this part of the test is related to the Rey-Osterrieth complex Figure (ROCF) test.
A variation of the Verbal Learning Test may be incorporated in the smart device. This test assesses verbal memory of the user. In this test, the smart device speaker reads out twenty words (from a library of all 3- 6-lettered from the English language dictionary). After an adjustable interval or delay time (immediate, 5 minutes or 20 minutes) the user is asked to recall the words that were read out using the smart device. The words may be displayed on the screen and be a pool of words that were read and not read through the speaker. The user has to identify the words that was read from such a list. This test assesses a person’s verbal memory. The test variation to the verbal learning test may be applied to any language. In this manner other tests that tests different cognitive domains may also be developed as applications on a smart device including Wisconsin Card sorting test for abstract thinking,
Statistical analysis, artificial intelligence, machine learning, deep learning algorithms may then be applied to the data for image processing, weighing of difficulty levels and scoring and other analytical processes, including the identification of any correlations with smell test data such as that described above. Integration of performance parameters of various cognitive domains (verbal and non-verbal memory, executive function, processing speed, fine motor abilities, attention, abstract thinking), and olfactory responses (olfactory identification score, olfactory discrimination and threshold identification score, smell test scan-to-scan response time as an indicator of executive function, odor specific response, olfactory intra-test consistency, olfactory response under stress) is performed using statistical, artificial intelligence, machine learning, deep learning algorithms to determine threshold values for normal and disease conditions. Disease conditions may include but not limited to Alzheimer’s disease, Parkinson’s disease, amnestic and non-amnestic mild cognitive impairment (MCI), Alzheimer’s disease due to MCI, dementia, multiple sclerosis, traumatic brain injury (TBI), Huntington disease, epilepsy, neuromuscular diseases, attention deficit disorders, brain tumors, olfactory neuroblastoma, nasal polyps.
The present application claims priority to U.S. Provisional Application No. 63/334,247, filed on Apr. 25, 2022.
Number | Date | Country | |
---|---|---|---|
63334247 | Apr 2022 | US |