User:Davehuer/sandbox


 * NOTE *** This work was prepared using US patent law guidelines, and may includes uncited work that was created elsewhere. Not all sources are cited as under US intellectual property law a citation for those excerpts is not required.

AUDIOLOGICAL DRUGS

"Audiological Drugs" is a term coined by spatial/globular thinker, innovator, and entrepreneur Dave Huer of Vancouver, BC, Canada to describe a proposal to develop sound-based drugs that can be delivered by smartphone, "smart earbuds" and wireless networks.

The proposal was first described in an provisional patent application to the US Patent Office. Recently the details of that provisional claim have been disseminated to prevent the audiological industry concept from being blocked by competing industries. The claim application is disclosed here, and is disclosed so any scientist anywhere in the world can explore the ideas in the claim without fear of stepping into a patent law minefield.

Auditory Cognitive Feedback Devices for Cognitive Re-ordering

FIELD OF THE INVENTION

[0001] The present invention relates to devices and methods for improving cognitive action. BACKGROUND OF THE INVENTION

[0002] When people speak, they cognitively rebuild pre-imagined sentence models. However, when a stutterer speaks, their brain occasionally “loses” parts of these sentence models, and the stutterer may get stuck trying to find the missing sounds (thereby producing the classic physical evidence of stuttering: repetitious and or prolonged and or blocked speech) while simultaneously searching for alternate words to fill the gap. The stutterer’s brain appears to have difficulty remembering parts of the sentence model.

[0003] Researchers have helped stutterers by developing hearing-aid-like devices to replicate the ‘Choral Effect’, i.e. the tendency of stutterers to speak clearly when singing, or speaking in unison with others. These altered auditory frequency devices recreate sound inputs with a short echo-like delay that is heard by the wearer thereby providing exogenously-generated delayed auditory feedback ("DAF"), and/or frequency altered feedback ("FAF")” and/or masked auditory frequency (“MAF”) sounds, as described in USP 5,961,443 by Rastatter et al. To use such a device, users start speaking, and then simultaneously pay attention to both the distracting sounds of the device when the device commences to replay the delayed sound, and their own voice. The delayed sound replays as a continuous thread until slightly after sound inputs stop being heard. Recently, a portable therapeutic Choral Sound Device (“CSD”) marketed under the trademark SpeechEasy™, and related stuttering enhancement treatment methods were described in Rastatter et al. These devices and methods employ altered auditory feedback (auditory delay and or frequency shift signals) delivered to a stutterer via a portably configured device.

[0004] Some prior art states that CSDs “may be particularly suitable for treating stuttering” and it “may also be used to treat subjects having non-stuttering pathologies to facilitate and or improve communication skills (our italics), including reading ability and or writing, spelling, and the like” These pathologies include non-stuttering speech and or language related disorders such as Parkinson's disease, autism, reading disorders, aphasis, dysarthria, dyspraxia, voice disorders, and/or speech rate disorders.

How CSDs address stuttering

[0005] CSDs were developed to address stuttering, a speech communication disorder which is also treated using different modalities such as speech and/or hearing therapy, counseling, psychiatric therapy, drug therapy, and other electrical signal modification therapies. CSDs were developed to replicate the ‘Choral Effect’ hypothesis, the proposal that the tendency of stutterers to speak without stuttering when speaking in unison with other people, or that the sounds generated by other people could be employed to ameliorate stuttering by mimicking this effect using assistive electronic technology.

[0006] The ‘Choral Speech’ effect is known to initiate an appropriate fluency enhancing voice gesture that is hypothesized to circumvent the predominate etiological factor that is exhibited or manifested due to a lack of inhibition on the part of the auditory cortex in assimilating the appropriate plan for smooth execution of the speech act. Experiments have generated and compared exogenous stuttered and normal speech signals for effectiveness, and demonstrated that exogenously-generated speech enhances fluency potential, for example., Fox et al., A PET Study of the neural systems of stuttering, 382 Nature pp. 158-161 (1996); Wu et al., A positron emission tomograph deoxyglucose study of developmental stuttering, 6 Neuroreport pp. 501-505 (1995).

[0007] CSDs include delayed auditory feedback ("DAF"), frequency altered feedback ("FAF"), and masked auditory feedback ("MAF"). DAF delays delivery of the user’s auditory feedback. FAF changes the pitch at which the user hears his or her voice. MAF generates noise that masks the user’s auditory feedback.

[0008] CSDs use methods and devices which employ a "second" exogenously generated auditory signal which is produced by a sound or sounds corresponding to spoken vocal utterances or natural speech (independent of the in situ uttered speech of the speaker) or alternatively by generated sounds aiming to mimic the aural characteristics of the gestures that trigger the auditory cortex of the user. The second exogenous auditory signal can alternatively be generated by other than spoken speech so as to simulate natural sounds (such as generated electronically, mechanically, or electromechanically); these simulated sound(s) should be configured to simulate the auditory gestures which trigger the auditory cortex of the hearer.

[0009] CSDs aim to mimic the choral speech effect to address pathologies and disorders that have a speech affect and which are known to reduce speech dysfluencies that occur with these conditions; but only aim to replicate this effect after such disorders and pathologies have developed; and further only address pathologies and disorders that affect speech and language communication skills.

[0010] Recent brain imaging procedures have employed choral speech condition to induce fluent speech in adults who stutter and have compared the brain images obtained to those attained during stuttering events/behaviors. A lack of activation in the auditory areas during the motor planning of stuttered speech was observed, but an essential normalization under the choral speech condition was noted, indicating fluency enhancing potential. Nevertheless, it has not been demonstrated why the choral speech condition normalizes speech; only that it does.

SUMMARY OF THE INVENTION

[0011] The present invention relates to treatments, devices and methods to prevent, minimize, and or reduce the incidence of and or address cognitive dysfunctions involving disordering of memory and social anxiety, and traumatic stress. To better distinguish our invention’s application from the devices developed to address stuttering and other disorders and pathologies that affect the ability to communicate, we collectively term those devices CSD, and describe the device according to the invention as an “Auditory Cognitive Device” (“ACD”).

[0012] The “second” speech signal of the present invention is an auditory stimulus which is a spoken speech signal (that is, a voice gesture associated with a vocal cord of a person) or artificial electronic, mechanical, or electromechanical sounds. The second speech signal can be either stuttered or fluent, and/or coherent (a string of meaningful sounds forming words) or incoherent (the sound(s) having no understandable or meaningful content), or sub-audible (the sound(s) having no content that is hearable by human beings).

[0013] The second auditory speech signal can be used as an alternative to DAF or MAF, which typically manipulates, alters, interferes or competes with the contemporaneous auditory cortical activity of the hearer.

[0014] The second auditory speech signal may comprise a prolonged uttered or spoken sound associated with a natural voice gesture, such as a single syllabic vowel, consonant, a combination of vowels and/or consonants, or artificial electronic, mechanical, or electromechanical sounds. The second speech signal can be relayed to the user in such a way as to be intermittent, sustained for a determined period of time, or substantially continuous with the cognitive processes of the user.

[0015] The second, or exogenously generated auditory signal, may be generated exogenously by someone other than the hearer (or generated by a device which can substantially replicate the desired output in order to trigger the auditory cortex of the hearer, as noted above). The second auditory signal may be recorded and stored in advance of use, so that it can be conveniently and reliably provided or audibly relayed at a desirable time (and repeatable at appropriate times).

[0016] The exogenously generated second auditory signal may be a spoken or artificially reproduced prolonged sound (such as the last sound in the word "sudden"). The prolonged auditory sound may be a steady state single syllabic sound. The prolonged auditory sound may be a vocal tract or artificially produced output associated with producing a steady state vowel sound. The exogenously generated auditory signal can be provided at the start of use of the ACD, such as when a person begins to hear using the ACD at intervals prior to and/or during and/or following a learning event, is experiencing a stressful event, or even just at intervals prior to and/or during and/or following a stressor event.

[0017] The second speech signal can be provided as an arrangement of different auditory gesture sounds, the output of which can be varied to alter the exogenously generated auditory signal auditory stimulus provided, over time.

[0018] The second, or exogenously generated speech signal, may be pre-recorded and relayed to the user at desired or appropriate times (either as activated by user input or automatically activated upon initiating use of the ACD). The volume and/or duty cycle of the output are preferably variable to allow a user to adjust the output to his or her needs. That is, in one embodiment, the user can increase or decrease the duration or frequency of the transmitted second speech signal from a continuum ranging from continuously outputting the signal during audio production or a desired output time period, to intermittently outputting the signal at desired adjustable intervals during the desired output period.

[0019] The method according to the invention uses auditory feedback technologies to provide improved cognitive performance. Using the method enhances cognitive abilities and stress management and decreases anxiety.

BRIEF DESCRIPTION OF THE FIGURES

[0020] Figures 1.a., 1.b., 1.c., and 1.d. are block diagrams of a device according to the invention;

[0021] Figure 2.a., 2.b., and 2.c. are perspective views of embodiments thereof;

[0022] Figure 3 is a flow chart showing the device software parameter installation process according to an embodiment of the invention;

[0023] Figure 4 is a flow chart showing the hearing evaluation process according to an embodiment of the invention;

[0024] Figure 5 is a flow chart showing the fitting and assessing process according to an embodiment of the invention;

[0025] Figure 6 is a flow chart showing the method of learning to use the device according to an embodiment of the invention; and

[0026] Figure 7 is a flow chart showing an embodiment of the method of actual use of the device according to the invention.

DETAILED DESCRIPTION

Application to cognitive re-ordering

[0027] The method according to the invention has an impact on cognitive skills. Several cognitive disorders and pathologies affect cognition and do not affect clarity of communication.

[0028] The process of improving cognitive abilities, such as memory, in humans is complicated. Generally, performance must be quantified by measurable attributes and improvement of cognitive skills. Cognitive skill is defined as a time-bounded decision process.

[0029] The term "cognition" describes those mental processes that allow us to perform day-to-day functions, for example, the ability to pay attention, to remember and to solve problems are all parts of cognition. Cognition has different components, including spatial orientation, short term memory, long term memory, planning and prediction, set switching, speed, and procedural memory.

[0030] Cognition can be categorized according to an aspect or "domain" of thinking. The three most commonly cited domains that together represent overall cognition performance are Attention, Memory and Executive Function.

[0031] Each of these broad domains encompasses more specific aspects of cognition. For example, at one level memory can be broken down into short-term and long-term memory, while attention can be broken down into many components including sustained and divided attention. For example, intact attentional abilities are required to concentrate on and complete even the simplest of tasks, whilst preserved memory is additionally needed to perform well on tasks of new learning.

[0032] A test subject, when using the ACD, reported greatly enhanced cognitive abilities. The user has experienced an improved ability to remember procedural memories and routines such as such as accounting and software procedures, solving mathematical formulas, and remembering gym workout plans without needing to frequently consult a list of planned exercises. The test subject had avoided seeking employment where these forms of memory were required for over 20 years, as these forms of knowledge were a struggle to recall. Two years after the test subject dropped out of technical college—after again experiencing declining performance in accounting courses as remembering requirements increased—the user was accepted into an accelerated university Commerce degree program. During the intervening period, the test subject began using the ACD. During first term, the subject noted improvements to performance using the ACD; for example, when doing first term accounting of comparable difficulty to the college courses, mark averages jumped 23%. Just before term one final exams, the test subject suffered a concussion and loss of memory for weeks. But the test subject recovered using the ACD as a cognitive therapeutic tool, wrote the accounting exams, and then after graduating, worked as a budget clerk using math, finance and software procedures that were a struggle to remember previously.

[0033] Verbal speech occurs when sentence models are “replayed” by the speaker. When people employ speech to communicate, neural networks feed sounds into spoken speech, which has the effect of harnessing the sentence models previously constructed by the mind in anticipation of speaking: what is produced as speech are thought-models to be communicated using vowel and consonant Speech Sound Units (“SSUs”) that are assembled together to form words and sentences (“Thought-Speech Models” or “TSM”). With some people, the capacity to accurately reproduce or rebuild TSMs is diminished. For example, the stuttering brain appears to have difficulty remembering parts of each TSM — variably repeating, prolonging, and/or misplacing a single or multiple units of speech, such as an audible or inaudible sound feature, phoneme, syllable, word, phrase, or entire sentence — and gets stuck trying to find those missing thought-speech sounds (producing the classic physical evidence of stuttering: repetitious and or prolonged or blocked speech) while simultaneously searching for alternate words to fill the cognitive gap that forms when a TSM unit cannot be assembled.

[0034] The method according to the invention herein uses audible and or sub-audible feedback to improve and perpetuate effective functioning, and also to forestall chance, temporary and or pathological appearances of the “TSM unit gap” that evidences the presence of disorders and pathologies. In the method according to the invention, the delayed sound packet gets interwoven into the neural modeling of thoughts and memories, becoming a exogenously-generated Neural Audio Data Backbone (“NADB”) that the brain recalls more easily thus enabling the user to have a more accurate mental model to rebuild.

[0035] A backbone network or network backbone is a part of computer network infrastructure that interconnects various pieces of network, providing a path for the exchange of information between different LANs or subnetworks. A backbone can tie together diverse networks in the same building, in different buildings in a campus environment, or over wide areas. Normally, the backbone's data capacity is greater than the networks connected to it. A large corporation that has many locations may have a backbone network that ties all of the locations together, for example, if a server cluster needs to be accessed by different departments of a company that are located at different geographical locations. The pieces of the network connections (for example: Ethernet, wireless) that bring these departments together is often mentioned as network backbone. Network congestion is often taken into consideration while designing backbones.

[0036] In the present invention, the NADB can be considered analogous to a network backbone, and TSMs can be considered analogous to a bridge, where the thought-speech sound units are strung together as if they are a series of beams laid across a series of bridge piers standing in a waterway. The recalling of data created during the modeling (whether recalled as thoughts and or memories and or audible or inaudible speech) occurs when our brain rebuilds the model by laying each sound unit in its appropriate place as a span atop the piers of this metaphorical “bridge”. The NADB can be considered analogous to a line strung from riverbank-to-riverbank atop the piers: the gaps in the metaphorical TSM “bridge” model are bridged by a continuous sound thread—the NADB that the other parts of the “bridge” model more easily adhere to.

[0037] The method produces memory entrainment and/or neurofeedback wherein auditory feedback signals and electronic watermarking are employed to embed information into a signal, such as a digital and or analog audio signal, that is woven into the exogenously-generated “delayed sound” output signal produced by a communication device, wherein this exogenously-generated “delayed sound” gets interwoven into the neural modeling of the sentence, to produce a exogenously-generated Neural Audio Data Backbone (“NADB”) that assists the brain as it models memory frameworks. The NADB becomes the key to a set of memories and/or memory components and/or fragments that the brain recalls more easily, and which concurrently treats and/or prevents the development of traumatic stress, post-traumatic stress disorder, social anxiety, or induces relief of the symptoms thereof, and/or affects situational awareness in the user.

[0038] The method uses watermarked audio signals (WAS) containing metadata that indicates control parameters that govern the modulation of the ACD. Metadata is loosely defined as data about data. Metadata is traditionally found in the card catalogues of libraries and is today commonly used to describe three aspects of digital documents and data: 1) definition, 2) structure and 3) administration. By describing the contents and context of data files, the quality of the original data/files is greatly increased. For example, a webpage may include metadata specifying what language it is written in, what tools were used to create it, and where to go for more on the subject, allowing browsers to automatically improve the experience of users. Metadata may be embedded into the WAS by any number of methods to manage the signal received by the user after the system defines the first use results of cognitive tests completed by the user upon activating the device. If the signal is copied, then the information is also carried in the copy as metadata.

[0039] Entrainment and/or biofeedback is directed towards neuroplastic modification of the user’s biological neural network for all cases involving the treatment and rehabilitation of neurological and cognitive disorders, as well as pathologies, other than those that present communication difficulties as an artifact of the user’s disordered and or pathological state, and to minimize, forestall and or inoculate users against conditions that give rise to such states.

[0040] Although the ACD 1 is directed to use by humans with disorders and pathologies that do not affect the ability to communicate, the characteristics of the method make it reasonable to infer that humans that do not immediately evidence symptoms of disorders and pathologies that have neurological characteristics — including those with a genetic predisposition to such disorders and pathologies — could with repeated use of the devices, systems and methods disclosed herein, during infancy, adolescence, and/or adult life, be able to use ACD 1 to ameliorate memory disjointedness and fragmentation and/or loss by minimizing, relieving, and/or inoculating and preventing the onset of effects that give rise to such disorders and pathologies.

[0041] ACD 1 and various components thereof are shown in Figures 1.a. through 1.d. These components include: receiver 1-1, for receiving auditory signals; circuit 1-2, for providing an auditory delay or feedback shift, and transmitter 1-3, such as a speaker, for transmitting the altered signal to the user.

[0042] ACD 1 can be manufactured in various shapes, sizes and guises, and is able to generate auditory feedback signal frequencies, such as, but not limited to, delayed, altered, and masked auditory frequencies. ACD 1 is placed in-situ or in close proximity to one and/or two ear canals of the user. Typical embodiments of ACD 1 are shown in Figures 2.a and 2.b.; Figure 2.c. is a typical embodiment that has external power and control components.

[0043] CSDs “fool” the brain by mimicking the “choral effect” to recreate sound inputs with a split-second, echo-like delay that is heard by the wearer. To spark the effect, users start speaking in parallel with the choral effect sound that is heard, while hearing unmodified sounds in their other ear; hence, simultaneously paying attention to the sounds heard through both ears (it being assumed that a person hearing through one ear is equivalent to hearing through both ears if the person experiences hearing challenges or no hearing in one ear). The CSD signal replays continuously until stopping after the original sound inputs stop being recorded.

[0044] ACD 1 functions by using the “choral effect” to recreate sound inputs with a split second, echo-like delay that is heard by the wearer, but simultaneously alters the data structure of thoughts flowing through the mind during construction of those thoughts, by enabling the brain to more accurately recall those thoughts as memories by acting as a exogenously-generated NADB during thought construction, and reducing the fragmentation of thoughts and memories during stressful events while more effectively improving the knitting together of those thoughts and memories during and after a stressful event.

Application to cognitive re-ordering for anxiety and stress management

[0045] The method according to the invention can provide for enhanced cognitive abilities and reduced anxiety and responses to stressful environments. Sound-driven therapies can reduce anxiety and current treatments are not dependably long lasting and may include pharmaceutical products.

[0046] The process of reducing anxiety in humans is complicated. Generally, anxiety is considered a continuum of anxiety states that include generalized anxiety disorder and social anxiety disorder, acute stress injury, post traumatic stress disorder, and panic attacks. The terms generalized anxiety disorder, social anxiety disorder, and post traumatic stress disorder, have been defined in the Diagnostic and Statistical Manual of Mental Disorders (“DSM”) IV.

[0047] Post-traumatic stress disorder (“PTSD”) and other Operational Stress Injuries (“OSI”) result from a traumatic experience and develop when acute stress injuries are not addressed through successful intervention and treatment. Post-traumatic stress can result from an extreme situation, such as combat or natural disaster, and can also result from long term (chronic) exposure to a severe stressor, for example soldiers in combat situations. Common symptoms include hypervigilance, flashbacks, avoidant behaviors, anxiety, anger and depression.

[0048] A panic attack is a discrete period in which there is a sudden onset of intense apprehension, fearfulness or terror, often associated with feelings of impending doom. During the attack, symptoms such as palpitations, sweating, trembling, sensations of shortness of breath, feeling of choking, chest pain or discomfort, nausea, feeling dizzy, feelings of unreality, fear of losing control or going crazy, fear of dying, paresthesias and chills or hot flushes may be present. Such effects are initiated by the (ortho-) sympathetic nervous system (“SNS”); one of the three parts of the autonomic nervous system, along with the enteric and parasympathetic systems. The general action of the SNS is to mobilize the body's resources under stress; to induce the fight-or-flight response. It is constantly active at a basal level in order to maintain homeostasis.

[0049] In humans the range of responses to threats is highly complex. In prehistoric times when the fight or flight response evolved in humans, the “fight” response was manifested in aggressive, combative behavior and the “flight” response was manifested by fleeing potentially threatening situations, such as being confronted by a predator. In current times, these responses persist, but fight and flight responses have assumed a wider range of behaviors. For example, the fight response may be manifested in angry, argumentative behavior, and the flight response may be manifested through social withdrawal and substance abuse.

[0050] Males and females tend to deal with stressful situations differently. Males are more likely to respond to an emergency situation with aggression (fight), while females are more likely to flee (flight), turn to others for help, or attempt to defuse the situation – 'tend and befriend'.

[0051] The stress response halts or slows down various processes such as sexual responses and digestive systems to focus on the stressor situation and may cause negative effects like constipation, anorexia, erectile dysfunction, difficulty urinating, and difficulty maintaining sexual arousal. These are functions which are controlled by the parasympathetic nervous system and therefore suppressed by sympathetic arousal.

[0052] Stress responses are sometimes a result of mental disorders such as post-traumatic stress disorder, in which the individual shows a stress response when remembering a past trauma; and panic disorder, in which the stress response is activated by the catastrophic misinterpretations of bodily sensations.

[0053] Managing anxiety in a stressful environment is challenging. People unthinkingly and instinctively respond to elevated anxiety levels using the so-called “fight or flight” response; or stay in the situation whilst consciously managing their response to the stressor. This third option can be learned through training, teaching, repeated practice, and or repeated exposure to the stressor. The challenge is that repeated exposure may or may not desensitize awareness of key cues that trigger responses. Simultaneously, the person experiencing traumatic stress may not be consciously aware that they could be managing the experience by separating forming memories into a jumble of fragments that are then recalled over months and years as the person’s mind attempts to slowly reassemble such fragments into a coherent whole.

[0054] It has been demonstrated that audio treatment can improve cognitive states, and reduce anxiety and associated affect. Animal studies have revealed that sound therapy can reduce the formation of fearful memory. Each time a frightening memory is retrieved, for example by a tone that reminded rats of having been shocked, the memory is in a labile state and susceptible to change. Rats treated with sound therapy showed lower levels of fear when they heard the sound; indicating that the process of consolidating fear-driven memory can be managed, for example, Marie-H. Monfils et al, Extinction-Reconsolidation Boundaries: Key to Persistent Attenuation of Fear Memories, Science, Vol. 324 no. 5929 pp. 951-955, 15 May 2009. DOI: 10.1126/science.1167975, Published Online 2 April 2009.

[0055] Neurologic music therapy (NMT) has showed improvement in executive function and overall emotional adjustment, and lessening of depression, sensation seeking, and anxiety in subjects, for example, Michael H. Thaut et al, Neurologic Music Therapy Improves Executive Function and Emotional Adjustment in Traumatic Brain Injury Rehabilitation, Center for Biomedical Research in Music, Colorado State University, Fort Collins, Colorado, USA. The New York Academy of Sciences, 2009.

[0056] The Virtual Reality Medical Center in San Diego, California uses virtual reality computer generated programs with physiological readings to monitor soldier reactions to incidents that cause them severe anxiety. The virtual reality programs are used to subject soldiers to multisensory stimulation that simulates battlefield conditions including scenarios that are reminiscent of situations where the soldier underwent the traumatic experience. The success for the program is 85 percent, indicating that sensory stimuli including sound can be used for anxiety reduction management.

[0057] The invention and method disclosed herein can be used to track psychological and physiological changes that occur in individuals in response to stressful environments; be used to establish a performance baseline against which to measure, model and monitor theoretical and actual uptake of data cascades of stress-induced behavior and responses; assist by tracking physiological and cognitive responses in real-time; and enable individuals to formulate effective responses.

[0058] The method according to the invention addresses anxiety and behavioral management by offering opportunities to manage responses to stress and anxiety by detecting minute auditory-triggered neurological, cognitive and physiological responses to stress and enabling individuals to improve their ability to make decisions upon experiencing physiological and cognitive responses to auditory cues.

[0059] A test subject, when using the ACD, reported greatly decreased social anxiety, and decreased Post Traumatic Stress Disorder effects. The test subject is a survivor of severe trauma, has experienced PTSD for many years, and reports a decrease in the experience of negative stress and social anxiety, and greater comfort and ability to withstand repeated contact with large numbers of other people on a daily basis.

[0060] In one embodiment, in anticipation of entering a high stress environment ACD 1 could be used to monitor physiological changes to the structure of the inner ear as the sounds of the stressful environment are filtered through the device; the data would be gathered to assess the individual’s responses under stress by replaying those commands back in simulations where the sounds of the stressful environment are re-experienced, whilst monitoring changes to brain function. The neurological changes would be paired with the physiological changes of the inner ear under each set of conditions — the actual conditions and the controlled laboratory environments.

[0061] In another embodiment, ACD 1 could be used to monitor anxiety response changes as the sounds of a stressful environment are filtered through the device prior to entering, experiencing, and leaving the stressful environment; data would be gathered throughout each stage to assess the individual’s responses by replaying those signals back in simulations where the sounds of the stressful environment are re-experienced, and assist the individual to better manage their anxiety responses to the simulated and actual environments.

[0062] In another embodiment, ACD 1 could be used to ‘re-order’ users to a time before the person experienced a stress-related event resulting in cognitive and or neurological harm. After a traumatic event occurs, the cognitive state of the user, as recorded as an interaction of the delayed signal output and the user via the recorded brainwave activity state can be used to “re-set” the cognitive characteristics of the user to the prior state.

[0063] Alternatively, the device and method according to the invention could be used to inoculate the user against the onset of disorders and pathologies if the user regularly uses the device to ‘maintain’ their cognitive state prior to the onset of disorders and pathologies.

[0064] For example, users could forestall the onset of PTSD by introducing sounds from ACD 1 into cognitive activity. Repeated use of such signals can reduce the danger of memory fragmentation that is a hallmark of PTSD by fixing the cognitive state of the user to a time before stress occurs. The invention may be a useful adjunct to existing techniques that introduce users to stress before entering a stressful environment. The invention can be used to enable users to experience less traumatic stress by using such devices as a cognitive prophylactic to neuro-inoculate against the onset of traumatic stress disorder, and to introduce cognitive management during an experience of stress, and to return to the calmness of a lower stress environment before leaving the high stress environment.

[0065] In another embodiment of the invention, the signal could be modulated to ensure that the brain does not become ‘familiar’ with a constant audio affect.

USING THE DEVICE

[0066] Software Installation: Figure 3 is a flow chart showing the device software parameter installation process according to an embodiment of the invention. A user reads the instructions and installs the software on a computing device, then installs a diagnostic jack into the computing device and calibrates the Audio Controls displayed on a Graphical User Interface that displays the diagnostic controls and functions of the software package.

[0067] Hearing Evaluation: Figure 4 is a flow chart showing the hearing evaluation process according to an embodiment of the invention. A person places the ACD Test Headset on the user, tests the user’s hearing using the device, determines the appropriate range of settings for User’s hearing attributes when using the ACD Test Headset, and calibrates the Audio Controls using the Computer Device’s Graphical User Interface that displays the diagnostic controls and functions of the software package.

[0068] Fitting and Determining Baseline Performance: Figure 5 is a flow chart showing the fitting and assessing process according to an embodiment of the invention. A person places the ACD/Test Unit on the user, connects the Diagnostic Jack to the ACD/Test Unit, connects the Diagnostic Jack to the Computing Device, and then activates the ACD/Test Unit testing protocol on the computing device. Using the testing protocol as a guide, Sound Parameters are introduced into the ACD/Test Unit and the Sound Parameters are optimized for the user. These optimized sound parameters become the User Parameter Profile which is recorded and saved as a file. The User Parameter Profile data is transferred to a Standard ACD Headnet which is an embodiment of the art consisting of earbuds attached to each other in a flexible wire net and or bundled wire strand which sits on and over the head of the user. Parameter settings are verified through discussion with the user.

[0069] While using the Standard ACD Headnet, a series of cognitive tests are employed to determine the subject’s cognitive domain performance, and may include Inductive Reasoning, Intelligence Quotient, Cognitive Development, Consensus Based Assessment, Memory, Self, Thought, Mental Chronometry, and Neuropsychological testing.

[0070] Assessing Performance Changes: Cognitive tests are designed to assess a single or only a few aspects of cognition. This means that a series of tests must be administered to get an overall ‘picture' or ‘map' of an individual's cognitive ability. Whilst using the Standard ACD Headnet, a series of computerized and or non-computerized cognitive tests are employed to determine whether the subject’s cognitive domain performance has improved, remained in stasis, or declined with use of the invention, and may include Inductive reasoning, Intelligence Quotient, Cognitive Development, Consensus Based Assessment, Memory, Self, Thought, Mental Chronometry, and Neuropsychological testing.

[0071] Learning to Use Device: Figure 6 is a flow chart showing the method of learning to use the device according to an embodiment of the invention. A person installs the UPF Datacard, and a power source such as the battery (shown here for illustrative purposes), and places the ACD/Headnet on the user’s head by first placing the headnet wire net and or bundled strand over the head and then placing the earbuds into the ear canals; activates the ACD/Headnet ensuring that the Power Indicator shows that the unit is receiving power, and connects the Diagnostic Jack to the Headnet and then the Computing Device. The ACD/Test Unit protocol is activated and used to ensure that the ACD/Headnet device settings optimize use of the uploaded UPF Datacard settings. The ACE/Headnet device is activated, and the user is trained to simultaneously pay attention to the exogenously-generated delayed audio sounds produced by the ACD/Headnet. When the user has met the training standards, audibility of the delayed signal is reduced.

[0072] Using the Device: Figure 7 is a flow chart showing an embodiment of the method of actual use of the device according to the invention: The user installs the UPF Datacard, and a power source such as the battery (shown here for illustrative purposes), and placing the ACD/Headnet on the head activates the ACD/Headnet by first placing the headnet wire net and/or bundled strand over the head and then placing the earbuds into the ear canals; then adjusts controls and activates the exogenously-generated Audible Delayed Audio Signal, and then reduces the audibility of the delayed audio signal.

EMBODIMENTS OF THE INVENTION

[0073] The method according to the invention uses auditory feedback technologies and is directed to methods, systems, and devices for use by humans and other species that do not necessarily experience disorders and pathologies that present communication difficulties as an artifact of the condition.

[0074] The method according to the invention is also directed to improve cognitive health and to treat memory dysfunction and or loss by improving the ability to effectively and consistently recall thoughts and memories, with or without associated social anxiety and discomfort. The method may also be used to ameliorate memory loss, to measure changes in memory capacity and the effectiveness of pharmaceuticals and other neurological treatments, and to inoculate against the onset of cognitive disorders and pathologies. Generally, it is aimed to users who desire to improve their ability to concentrate, have clarity of thought and effectively recall thoughts and memories.

[0075] The method according to the invention is also directed to measure changes in memory capacity by establishing a baseline for cognitive functioning before the onset of disorders and pathologies, and inoculate against the onset of cognitive disorders and pathologies.

[0076] Further, the method is useful for tracking psychological and physiological changes to individuals and groups of individuals responding to stressful environments, to establish performance effectiveness, to track cognitive and physiological responses in real-time, and to enable individuals to improve speed and effectiveness as they formulate actionable responses during stressful conditions.

[0077] The method uses ACDs employed in regular use, and the continual, constant and or on-demand use of ACDs can enhance, augment and/or improve the cognitive performance of the user; provide as a safe, portable, and effective device that may be a cable-connected and/or wireless and/or implanted and/or contact-interfacing communication device, and/or a signal received remotely, to minimize the effect of neurological and or cognitive disorders and pathologies; and to forestall or inoculate against the onset of disorders and pathologies by allowing the use of the device during infancy, adolescence, or adult life.

[0078] The device preferably includes a compact and economical electronic component and is small enough to be insertable into or held and or worn adjacent to an ear or ears, or inserted or held against or adjacent to the cranial bone structure of the user.

[0079] The device may allow for providing episodic and/or on-going treatments and therapies in clinical or daily extra-clinical use before disorders and pathologies arise in an individual.

[0080] The device allows ongoing use (in addition to providing episodic treatments and therapies in clinical or daily extra-clinical use) during or after disorders and pathologies arise in an individual.

[0081] The device also allows for improving cognitive performance, by gathering and computing a collection of data that can be used for measuring cognitive performance changes in anticipation of the onset of neurological and or cognitive disorders and pathologies that may arise in the individual, and thence to measure such changes to enable the individual or group of individuals to formulate anticipatory response strategies during such events, and to respond with greater immediate effectiveness in stressful environments before and during such events.

[0082] The device is a ACD device and or electronic component and or wireless signal that mixes a exogenously-generated Neural Audio Data Backbone (NADB) into the content being heard by the user, whether generated in the device in situ or by a signal which is retransmitted adjacent to or in the ear of an individual or inserted or held against or adjacent to the cranial bone structure of the individual.

[0083] The device also allows for exogenously-generated signals to be modulated ensuring that the brain does not become ‘familiar’ with a constant audio affect that may wear off.

Embodiment 1: Generated by communications device

[0084] In this embodiment, ACD 1 comprises an audio storage medium comprising at least one pre-recorded auditory stimulus signal thereon and a speaker operably associated with the audio storage medium to output the auditory signal therefrom. The device also includes a power source in communication with the audio storage medium and speaker and an activation switch operably associated with the power source. The device is configured such that the auditory stimulus or second audio signal can be repeatedly output to a user at desired times corresponding to at least one of during an episodic event; in advance of a hearing event (the activation of hearing on the part of the user); and during a hearing event to thereby provide an auditory stimulus to the user/person to enhance the cognitive performance thereof.

[0085] ACD 1 includes a user input trigger switch operably associated with the auditory generator. The user input trigger switch is configured to accept user input to initiate a substantially immediate delivery of the auditory stimulus (second auditory signal). The device can also include an intermittent output switch or button that can allow a user to determine the length, or repeating cycle of the transmitted output signal (to allow the user to vary the auditory stimulus). Similarly, the device can include a selectable signal button to allow the user to select which signal will be transmitted or to vary the output signal automatically over desired time periods.

[0086] In one embodiment, the device further includes a signal input device and signal processor configured to receive auditory signal. In this embodiment, the device can then automatically output the auditory stimulus signal to the user based on an analysis of a received signal associated with the incoming auditory signal, such that the auditory stimulus signal is provided substantially contemporaneously with the user's hearing independent of (without) auditory feedback or manipulation of the user's contemporaneous hearing itself. Advantageously, the auditory stimulus signal is delivered in a manner which allows the user to hear at a substantially normal hearing pace.

[0087] The device can also be configured to identify the initiation of auditory production on the part of the user or artificial sound source and the termination of speech by the user or artificial sound source by monitoring the signal received by the microphone and signal processor. The device can substantially continuously or intermittently output the auditory stimulus signal while the user is hearing (such as concurrent with or during the auditory stimulus signal).

[0088] In one embodiment, the device can also include a detector operably associated with the processor and receiver. The detector is configured to detect the onset of or an actual auditory input event, and, in operation, upon recognition of the initiation of an impending or actual auditory input event on the part of the user, the device can output the auditory stimulus signal to the user.

[0089] In all embodiments, the auditory stimulus signal can comprise a plurality of different natural prolonged sounds associated with voice gestures or artificially produced sounds which are independent of the contemporaneous speech and hearing of the user and can be configured to be serially output to the user.

[0090] In all embodiments, the ACD may optionally include a watermarked audio signal (WAS) containing metadata that indicates control parameters that govern the modulation of the ACD. Metadata may be embedded into the WAS by any number of methods to manage the signal received by the user after the system defines the first use results of cognitive tests completed by the user upon activating the device. If the signal is copied, then the information is also carried in the copy as metadata.

[0091] The present invention provides an auditory stimulus which can be an effective acoustic mechanism to enhance cognitive performance in persons while also allowing users to function at a substantially normal pace and without requiring the use of ACDs. The second stimulus auditory signal can be meaningful or not meaningful and can be presented in incongruent auditory signals at normal or stuttered fluency or in steady state signals having appropriate duration or prolonged or sustained gesture sounds.

[0092] In an embodiment of the invention, the devices and methods can be configured to provide an ACD signal which may be but is not limited to, a delayed voice and or song and or noise waveform, via a miniaturized electronic apparatus configured to fit inside communication devices including, but are not limited to, an earbud, portable miniaturized devices such as ITE (in the ear), BTE (behind the ear) or OTE (over the ear) speech and or hearing aid devices, a mobile device, a smart phone, an Apple iPhone™, a telephone, a cellular telephone, a BlackBerry™ device, a personal digital assistant (PDA), an MP3 player, wearable devices (featuring a body area network), a headset, a Headnet consisting of earbuds attached to each other in a flexible wire net and or bundled wire strand which sits on and over the head of the user, a laptop, a computer, telephone, or any other type of computer or communicating method or communications technology system. The device containing the signal generator and or transceiver may also be distinguishable from a communication device yet be like a hearing aid or contained within a hearing aid that is able to be held and or worn and or be insertable into an ear or held adjacent to an ear so as to promote on-demand and or constant daily use, etc.; and could optionally have the signal transmitted through remote wires or cabling or electrodes or implants or adjacent systems and casings when in operative position on or in the user, or function as a wireless device and or other remote device. In other embodiments, the second audio signal can be held in or incorporated into an audio chip or incorporated into (wrist or other type) watches, bracelets, lapel pins, necklaces or other proximately worn (within the audible range of the user) jewelry such as necklaces and earrings, or headbands, hats, and the like.

[0093] Some embodiments of the devices of the present invention may employ external battery packs while others may employ internal battery power sources. Of course, extension cords and direct power cords and trickle chargers can also be employed. One example of a known hearing aid with an external battery and processing pack is the PHOENIX produced by NICOLET Company of Madison, Wis. Another example of a hearing aid device with an external battery pack is the QUIETPRO produced by Nacre of Norway.

[0094] As will be appreciated by one of skill in the art, the present invention may be embodied as methods, devices or computer executable programs. Accordingly, the present invention may take the form of a hardware embodiment or an embodiment of software or an embodiment combining software and hardware aspects.

Embodiment 2: Received by communications device

[0095] In another embodiment of the invention, ACD 1 may be, but is not limited to, a delayed voice, song and or noise waveform, delivered to communication devices by wireless, cable and or telephone line transmission through an infrastructure for sending and receiving signals and messages according to one or more formats, standards, or protocols, or mobile applications, as a separate sound packet wherein the sound packet contains the necessary data to generate the distinguishing features that an on-board electronic apparatus would generate.

[0096] In all embodiments, the ACD may optionally include a watermarked audio signal (WAS) containing metadata that indicates control parameters that govern the modulation of the ACD. Metadata may be embedded into the WAS by any number of methods to manage the signal received by the user after the system defines the first use results of cognitive tests completed by the user upon activating the device. If the signal is copied, then the information is also carried in the copy as metadata.

[0097] The foregoing is illustrative of the present invention and is not to be construed as limiting thereof. Although a few embodiments of this invention have been described, those skilled in the art will readily appreciate that many modifications are possible in these embodiments without materially departing from the novel teachings and advantages of this invention.

[0098] Accordingly, all such modifications are intended to be included within the scope of this invention as defined in the claims. In the claims, means-plus-function clauses, if used, are intended to cover the structures described herein as performing the recited function and not only structural equivalents but also equivalent structures. Therefore, it is to be understood that the foregoing is illustrative of the present invention and is not to be construed as limited to the specific embodiments disclosed, and that modifications to the disclosed embodiments, as well as other embodiments, are intended to be included within the scope of the appended claims.

I claim:

1. A device, comprising: an audio storage medium having a pre-recorded auditory stimulus signal thereon; a speaker operably associated with the audio storage medium to output the auditory signal therefrom; a power source in communication with the audio storage medium and speaker; an activation switch operably associated with the power source’ wherein the auditory stimulus can be repeatedly output to a user at desired times corresponding to at least one of: during an episodic event; in advance of a hearing event; or during a hearing event; to thereby provide an auditory stimulus to the user to enhance the user’s cognitive performance.

2. A method of enhancing a user’s cognitive performance, comprising: a. providing a speaker configured to generated sounds audible to the user; b. proving a audio storage medium configured to record sounds generated by the user;

c. on occurrence of a hearing event, i. said storage medium recording said event, ii. said speaker generating said event to said user;

d. wherein repetition of said event to the user enhances the user’s cognitive performance.

Abstract

A device is provided including an audio storage medium with at least one pre-recorded auditory stimulus signal thereon, and a speaker operably associated with the audio storage medium to output the auditory signal therefrom. The device also includes a power source in communication with the audio storage medium and speaker, and an activation switch operably associated with the power source. The device is configured such that the auditory stimulus or second audio signal can be repeatedly output to a user at desired times corresponding to at least one of during an episodic event; in advance of a hearing event (the activation of hearing on the part of the user); and during a hearing event to thereby provide an auditory stimulus to the user/person to enhance the cognitive performance thereof.