Abstract: Disclosed is a finger cuff attachable to a patient's finger to be used in measuring the patient's blood pressure by a blood pressure measurement system utilizing the volume clamp method. The finger cuff may include a light emitting diode (LED) and photodiode to form an LED-PD pair to perform measurements of a plethysmogram signal to aid in measuring the patient's blood pressure; and a bladder. The bladder includes a bottom portion that abuts only the bottom portion of the patient's finger to apply concentrated pressure only on the bottom of the patient's finger near both of the patient's two arteries, wherein, when the finger cuff is placed around the patient's finger, the bottom portion bladder and LED-PD pair aid in measuring the patient's blood pressure by the blood pressure measurement system.

Abstract: Disclosed is a finger cuff that is attachable to a patient's finger to be used in measuring the patient's blood pressure by a blood pressure measurement system utilizing a volume clamp method. The finger cuff comprises a bladder configured to exert pressure on the patient's finger. The finger cuff further comprises a plurality of light emitting diodes (LEDs) and a plurality of photodiodes (PDs) that respectively align with one another to form a plurality of LED-PD pairs. When the finger cuff is placed around the patient's finger, the bladder and the plurality of LED-PD pairs aid in measuring the patient's blood pressure by the blood pressure measurement system utilizing the volume clamp method.

Abstract: Disclosed is a finger cuff assembly that is attachable to a patient's finger to be used in measuring the patient's blood pressure by a blood pressure measurement system. The finger cuff assembly includes a plethysmograph. The plethysmograph includes a light emitting diode (LED)—photodiode (PD) pair that aids in measuring the patient's blood pressure by the blood pressure measurement system. The finger cuff assembly further includes an outer ring and a bladder. The bladder is contained within the outer ring and includes an inflatable inner portion and a finger cavity. The patient's finger with the plethysmograph surrounding the patient's finger may be received and surrounded within the finger cavity of the bladder.

Abstract: A method for establishing a personal blood pressure estimation model dedicated for a specific user includes: receiving a first reference measurement result of a reference sphygmomanometer; using a PPG sensor to measure a blood pressure of the specific user to generate a first PPG signal; calculating a first estimation result of the blood pressure of the specific user according to the first PPG signal; generating a first regulating parameter by comparing the first reference measurement result with the first estimation result; and establishing the personal blood pressure estimation model by using the first regulating parameter to adjust a set of parameter factor (s) of a basic blood pressure estimation model.

Abstract: Some embodiments provide a wearable monitoring device including a motion sensor and a photo (PPG) sensor. The PPG sensor includes (i) a periodic light source, (ii) a photo detector, and (iii) circuitry determining a user's heart rate from an output of the photo detector. Some embodiments provide methods for operating a heart rate monitor of a wearable monitoring device to measure one or more characteristics of a heartbeat waveform. Some embodiments provide methods for operating the wearable monitoring device in a low power state when the device determines that the device is not worn by a user.

Abstract: A method and system are provided for measuring the cognitive state of an individual by combining analysis of 2 independent quantities derived from a single sensor. The method comprises placing an array of electrocardiogram (ECG) sensors in contact with the individual. The sensors continually measure the ECG voltages and signal-to-noise ratios from each ECG. A distance to sensor and pressure applied to sensor our calculated for each ECG sensor that corresponds to the ECG voltage and signal-to-noise ratio measurements from each respective ECG sensor. Next, a graphical distance and pressure map is generated based on the combined signal-to-noise ratios of the ECG sensors and continually analyzed to determine the cognitive state of the individual.

Abstract: A mobile device for measuring at least one electrical biosignal. The device comprises a first input and a second input, a measuring circuit part for providing an output signal indicating the electrical biosignal to be measured, the measuring circuit part comprising a first input and a second input, and a charging circuit part for charging a rechargeable battery inserted in the device, the charging circuit part comprising a first input and a second input. The first input of the measuring circuit part and the first input of the charging circuit part are connected to the first input of the mobile device and the second input of the measuring circuit part and the second input of the charging circuit part are connected to the second input of the mobile device.

Abstract: Current technologies analyze electrocardiogram (ECG) signals for a long duration, which is not always a practical scenario. Moreover the current scenarios perform a binary classification between normal and Atrial Fibrillation (AF) only, whereas there are many abnormal rhythms apart from AF. Conventional systems/methods have their own limitations and may tend to misclassify ECG signals, thereby resulting in an unbalanced multi-label classification problem.

Abstract: Embodiments of the present disclosure describe methods of adaptive arrhythmia detection comprising monitoring ECG signals of a patient via a patient medical device, detecting and capturing ECG segments based on a heart rate threshold and an initial sensitivity level associated with the heart rate threshold; and adjusting the sensitivity level based on previously captured ECG segments. Embodiments of the present disclosure further describe patient medical devices comprising one or more electrodes and sensing circuitry for monitoring ECG signals of a patient; and a processing module configured to receive the monitored ECG signal, wherein the processing module detects and captures ECG segments based on a plurality of heart rate thresholds and one or more sensitivity levels associated with each of the heart rate thresholds, and adjusts at least one of the one or more sensitivity levels associated with each of the heart rate thresholds.

Abstract: A method of facilitating a skill learning process or improving performance of a task, comprising: determining a brainwave pattern reflecting neuronal activity of a skilled subject while engaged in a respective skill or task; processing the determined brainwave pattern with at least one automated processor; and subjecting a subject training in the respective skill or task to brain entrainment by a stimulus selected from the group consisting of one or more of a sensory excitation, a peripheral excitation, a transcranial excitation, and a deep brain stimulation, dependent on the processed temporal pattern extracted from brainwaves reflecting neuronal activity of the skilled subject.

Abstract: The present invention relates to a computer-implemented method for modifying nociception in a subject using electroencephalographic data acquired from the brain of a subject, the method comprising the steps of: receiving electroencephalographic data comprising at least two electroencephalographic signals measured simultaneously from at least two electroencephalogram channels, computing a Fourier transform of the at least two electroencephalographic signals on a temporal window; averaging complex Fourier coefficients in the frequency band of alpha waves; computing an alpha phase concentration neuromarker on consecutive epochs of the electroencephalographic data, generating a sensorial stimulus representing alpha phase concentration neuromarker using an output generator. The present invention also relates to a method for training a subject to reinforce self-modulation of pain pathways.

Abstract: A method and an apparatus provide electro stimulation to a test subject. A number of electrodes are connected to the brain of a test subject, wherein the voltages present on the individual electrodes are measured and analyzed after the delivery of a stimulus. During a preselection based on the analysis, individual electrodes are selected for the delivery of a stimulus, wherein one electrode is selected from the individual preselected electrodes and the stimulus is delivered to the brain by the electrode. Accordingly, in the analysis using the measurement signals during the preselection, the signals present on the electrodes are examined, in particular exclusively examined, for the presence of signal power or signal energies in the range from 60 Hz to 1 kHz, in particular between 60 Hz and 180 Hz.

Abstract: An electrocardiogram (ECG) measurement device for a vehicle is provided. The ECG measurement device includes an impedance compensator that corresponds to an electrode in contact with a body of a driver and configured to compensate an impedance of each of electrode signals received from the electrode. An electrode selector sequentially selects the electrode signals in response to receiving the electrode signals from the electrode. A differential amplifier differentially amplifies the electrode signals. In particular, each electrode signal has the compensated impedance. Additionally, a signal quality evaluator evaluates quality of an ECG signal output from the differential amplifier and a compensation controller then adjusts an impedance compensation value of each of the impedance compensators as a result of evaluating the quality of the ECG signal.

Abstract: An electrode cap contains at least one electrode array and is to be applied to a subject's head. The electrode array contains an insulating layer, two electrodes disposed opposite one another on the insulating layer, namely a first measurement electrode facing toward the subject's head and a reference electrode facing away from the subject's head. A conductive body abuts the reference electrode and is in electrical contact therewith, and is arranged on the side of the reference electrode that faces away from the subject's head. The individual conductive bodies of all the electrode arrays are electrically connected to each other.

Abstract: A biometric feedback system for providing biometric feedback to a subject while the subject performs a controlled physical movement includes an applied-force-recording interface and at least one controller electrically coupled to the applied-force-recording interface. The at least one controller receives applied force from the subject during the controlled physical movement and the applied-force-recording interface records data related to the applied force. The biometric feedback system also includes a dynamic surface electromyograph (“sEMG”) device that detects muscle tension along at least one muscle group of the subject while the subject performs the controlled physical movement and records data related to the muscle tension. A hub receives and processes data from the applied-force-recording interface and the dynamic sEMG device. A visual display displays the processed data from the hub.

Abstract: Bio-potentials are sensed on the skin of a subject. The bio-potentials include muscle bio-potentials, and nerve bio-potentials. Skin sensors are positioned to enable the sensing circuitry to emphasize the nerve bio-potentials and deemphasize the muscle bio-potentials in processed bio-potential signals generated by the sensing circuitry. A machine learning component identifies control sequences or tracks body motions based on the processed bio-potential signals.

Abstract: Provided are an ultra-low field nuclear magnetic resonance device and a method for measuring an ultra-low field nuclear resonance image. The ultra-low field nuclear magnetic resonance device includes an AC power supply configured to supply a current to a measurement target in such a manner the current flows to the measurement target, magnetic field measurement means disposed adjacent to the measurement target, and measurement bias magnetic field generation means configured to apply a measurement bias magnetic field corresponding to a proton magnetic resonance frequency of the measurement target. A vibration frequency of the AC power supply matches the proton magnetic resonance frequency of the measurement target, and the magnetic field measurement means measures a nuclear magnetic resonance signal generated from the measurement target.

Abstract: Systems, methods and apparatuses for performing wound analysis using THz imaging are provided. Due to the large complex component of water's dielectric constant in the THz regime, and the relative frequency invariance of non-aqueous tissue constituents, this modality is highly sensitive to the water content of tissue. It has been found that using THz imaging turns the presence of edema into a contrast mechanism, and allows for the use of the spatial distributions of edema to assess wound status immediately. Apparatus and methods enable earlier diagnosis of wound status which could result in accelerated treatment and shorter overall hospital stays.

Abstract: Devices that sense sweat and are capable of providing chronological assurance are described. The device uses at least one sensor to measure sweat or its components and to determine a sweat sampling rate. The chronological assurance is determined, at least in part, using the sweat sampling rate. The sweat sampling rate may be determined, at least in part, using a sweat volume and/or a sweat generation rate, both of which may be measured or predetermined.

Abstract: A method for selecting a food product for a subject having dysphagia comprising: (a) administering one or more food products comprising a volatile compound to the subject; (b) detecting release of the volatile compound in exhaled breath of the subject during and/or after swallowing of the one or more food products; (c) selecting the food product based on the release of the volatile compound in exhaled breath of the subject.

Abstract: A method for detecting wheeze from an audio respiratory signal comprises capturing the audio respiratory signal from a subject using a microphone. Further, the method comprises recognizing a plurality of breath cycles and a plurality of breath phases from the audio respiratory signal and detecting wheezing from the plurality of breath cycles and the plurality of breath phases. The detecting comprises analyzing a block of interest in the audio respiratory signal, wherein the block of interest comprises a plurality of frames. The detecting further comprises calculating an auto-correlation function (ACF) for each frame in the block and determining a maximum value of the ACF calculated for each frame in the block. Finally, the detecting comprises analyzing the maximum value to detect if wheezing is present in the block.

Abstract: A walking assistance device may be controlled using a personalized gait policy. A preset event is detected during a current gait cycle based on state information associated with a motion of the walking assistance device, a reward value of state information associated with the motion is evaluated at a point in time at which the event is detected, and a personalized gait policy is updated based on state information associated with the motion when updating of the personalized gait policy is determined to be required based on the reward value.

Abstract: A health care system for a caregiver to monitor and manage sleep metric, patterns and quality for an infant, including: a) a base station in communication with a network, b) one or more sensors in communication with the base station, c) a caregiver communication device in communication with the network; and d) a remote server and associated data store in communication with the network. The remote server is operative to: 1) access information from the information store indicating caregiver typing traits, 2) receive information from the sensors indicating a sleep quality for the infant, 3) receive information from the caregiver communication device indicating a caregiver perception of sleep quality for the infant, 4) recommend at least one caregiver action as a function of the caregiver typing traits, the sleep quality measures and the caregiver perception of the sleep quality; and 5) transmit the recommended action to the caregiver communication device.

Abstract: A patient monitor is disclosed for detecting patient movement or abnormal breathing. Images of a patient are obtained by a stereoscopic camera. These images are then processed by a 3D position determination module which determines measurements indicative of positions of at least part of a patient. The obtained measurements are then passed to a model generation module which generates a breathing model of the variation in position of the at least part of a patient during a breathing cycle. Subsequently abnormal breathing or patient movement can be detected by processing further images obtained by the stereoscopic camera to determine more measurements indicative of positions of at least part of a patient. These measurements are then compared with a stored breathing model by a comparison module.

Abstract: A monitoring system for monitoring the movement of a subject during toilet use comprises a set of sensors for detecting the presence of the subject in a toilet room, and their sitting or standing posture. A timer determines the duration of a stand-to-sit activity and the duration of a sit-to-stand activity during the toilet use, and this enables information about a chair rise test to be estimated.

Abstract: Technology for use with a touchscreen user interface device that uses gesture swipe data to provide an early potential indication of onset of Parkinson's disease. Technology for use with a touchscreen user interface device that uses gesture swipe data to provide an information about motor skill development of a child. Technology for use with a touchscreen user interface device that uses gesture swipe data to provide an information about reading ability development of a child.

Abstract: Technology for use with a touchscreen user interface device that uses gesture swipe data to provide an early potential indication of onset of Parkinson's disease. Technology for use with a touchscreen user interface device that uses gesture swipe data to provide an information about motor skill development of a child. Technology for use with a touchscreen user interface device that uses gesture swipe data to provide an information about reading ability development of a child.

Abstract: A radar system for detecting displacement of an internal organ of a patient in a medical scanner. The system includes a plurality of antennas arranged relative to an axis of the patient, wherein at least one antenna is configurable as a transmitting antenna and at least two antennas are configurable as receiving antennas. The at least one antenna is also configurable as a receiving antenna and the at least two antennas are also configurable as transmitting antennas. The system also includes a phased array radar system that energizes the antennas to form a radiation pattern that is directed toward internal organ movement of the patient wherein the phased array radar system operates in the ultra high frequency (UHF) bandwidth of the electromagnetic spectrum.

Abstract: A space-saving structural component for a device, the device configured to non-invasively determine a tissue bioparameter of a mammalian subject, the component comprising a wall surface including a grooved recess and at least one shoulder; and a substantially flat cover, the cover configured to cover the wall surface by moving from an open position far enough away from the wall surface to allow insertion of an appendage of the subject into a chamber defined by the grooved recess and the cover, to a closed position, the cover comprising a flexible material that, in the closed position, elastically deforms away from the wall surface when the appendage is present in the grooved recess and restores to a substantially flat state when the appendage is absent from the grooved recess, wherein in the closed position, when the appendage is absent from the recess, the cover is adjacent the at least one shoulder.

Abstract: A bio-signal detecting apparatus, and an apparatus and method for processing bio-information are provided. The bio-signal detecting apparatus includes: a plurality of detection modules, each detection module of the plurality of detection modules including a detector disposed at a center thereof and a plurality of light sources disposed at a circumference centered at the detector, wherein the plurality of detection modules include a first detection module and a second detection module that is disposed adjacent to the first direction module, a circumference of the first detection module intersects with a circumference of the second detection module, and one or more light sources of the plurality of light sources are disposed at intersection points where the circumference of the first detection module intersects with the circumference of the second detection module.

Abstract: Methods and devices for the diagnosis and treatment of diabetes are disclosed in which an analyte concentration within a peritoneal fluid of a human subject may be determined by implanting an analyte sensor apparatus in the subject where the apparatus may comprise a housing and a flexible sensing catheter which has a lumen with a plurality of apertures and an exterior surface with an analyte sensor affixed thereto. The catheter may comprise a proximal end attached to the housing and the remaining end may be positioned freely within the peritoneal space to contact peritoneal fluid where an analyte concentration in the peritoneal fluid may be sensed. The housing may be anchored at a subcutaneous site proximate the peritoneal space. The sensed analyte concentration may then be transduced into a transmittable electrical signal.

Abstract: Methods and apparatus for providing data processing and control for use in a medical communication system are provided.

Abstract: An apparatus for estimating a glucose exposure may include: a spectrometer configured to measure a plurality of Raman spectra from an object; and a processor configured to extract depth-specific protein information from the plurality of Raman spectra and estimate the glucose exposure of the object based on the depth-specific protein information.

Abstract: Embodiments of the present methods measure a concentration of a substance, such as glucose, in a body. The described embodiments change the temperature of the surface of a body from a first temperature to a second temperature, then change the temperature of the surface of the body from the second temperature back to the first temperature, and measure a first amount of infrared (“IR”) radiation absorbed or emitted from the surface of the body in a first wavelength band, and a second amount of IR radiation absorbed or emitted from the surface of the body in a second wavelength band at predetermined time intervals during the time period that the temperature of the surface of the body changes from the second temperature back to the first temperature. The described embodiments also measure a temperature at the surface of the body and an ambient temperature.

Abstract: Methods and apparatus for providing data processing and control for use in a medical communication system are provided.

Abstract: A medical photometer includes a signal producing section that produces a first control signal to emit a first light having a first wavelength, a second control signal to emit a second light having a second wavelength, a third control signal to emit a third light having a third wavelength, and a fourth control signal to emit a fourth light having a fourth wavelength, a signal acquiring section that acquires a first to fourth intensity signals, a processor, and a memory that stores instructions. In the medical photometer, the first wavelength and the second wavelength are selected as two wavelengths at each of which an extinction coefficient of blood is a first value. The third wavelength and the fourth wavelength are selected as two wavelengths at each of which the extinction coefficient of the blood is a second value which is different from the first value.

Abstract: A medical device for detecting at least one analyte in a body fluid, a method for assembling the medical device and a method of using the medical device are disclosed.

Abstract: The invention provides an implantable membrane for regulating the transport of analytes therethrough that includes a matrix including a first polymer; and a second polymer dispersed throughout the matrix, wherein the second polymer forms a network of microdomains which when hydrated are not observable using photomicroscopy at 400× magnification or less. In one aspect, the homogeneous membrane of the present invention has hydrophilic domains dispersed substantially throughout a hydrophobic matrix to provide an optimum balance between oxygen and glucose transport to an electrochemical glucose sensor.

Abstract: A simple auto electronic tourniquet includes a cuff, a pressurizing means for gradually raising the internal pressure of the cuff, a depressurizing means for gradually decreasing the internal pressure of the cuff, a pressure detecting means for detecting the internal pressure of the cuff, a target pressure setting means for setting the internal pressure of the cuff to a target pressure, a pressure control means for controlling the internal pressure of the cuff so that it gets close to the approximate value of the target pressure, and a notifying means for notifying that venipuncture is performable. In order to avoid excessive pressures, long-time performance of avascularization, sudden rise of pressure, which may cause patients to feel stressed, the width of the cuff of the tourniquet of the present invention shall be 75 mm or less, and more preferably in the range between 10 mm and 60 mm.

Abstract: A method for diagnosing schizophrenia may include the following steps: applying a plurality of different sensory stimuli to a subject with any time lag selected from 0 to approximately 1000 msec; obtaining subject's first answer regarding temporal order judgment of the plurality of different sensory stimuli applied; determining whether or not subject's passive time perception is normal on the basis of the first answer, wherein the subject's passive time perception can be determined to be normal when a correct-answer ratio of the first answer is high; displaying an image of a figure moving at a constant speed to the subject whose passive time perception is determined to be normal in the determination step; giving a signal to the subject; allowing the subject to respond to the signal; and obtaining subject's second answer as to whether or not the change in the image of the figure was caused due to the subject's own response.

Abstract: There is provided a method, device and system for performing an assessment of a subject, in particular a human subject, based on the detection of physical responses to stimuli. The method includes: providing a reference signature of the subject; obtaining a measurement signature corresponding to at least one physical response to a stimulus; comparing the measurement signature to the reference signature; and generating an output signal in response to the comparison; wherein the reference signature and the measurement signature conform to a predetermined format.

Abstract: A fatigue driving monitoring device includes a detector wearable on any part of a driver's body and a receiver disposed in the body of a vehicle or mounted in the body of the vehicle in a plug-in manner. The receiver is connected to the detector. The detector serves to detect the physiological data of the driver, such as heart rate, blood oxygen, heart rate variation and blood pressure. The physiological data are transmitted to the receiver via a transmission system and then the main control motherboard of the detector calculates, evaluates, analyzes and judges the current fatigue state of the driver. In case the detector detects that the driver is in a high-fatigue state or reaches a warning value, the receiver immediately actively emits a warning signal to remind the driver and a message is also transmitted to a control center to perform proper action.

Abstract: Provided is a wheel frame capable of measuring in detail the magnitude and the direction of a driving force while suppressing increase in weight and size of a driving wheel. A wheel flame (16a) includes a cylindrical hub (16c) into which an axle (11b) is rotatably inserted, a six-axis force sensor (16e) having an insertion hole (16e1) into which the hub (16c) is inserted, and an outer flange (16f) extending radially outward from an input section (16e2) of the six-axis force sensor (16e), wherein a hand rim (17) is attached to the outer flange (16f).

Abstract: This invention relates to methods for ascertaining at least one of liver fibrosis or cirrhosis in a subject, by processing of one or more medical images of the liver, using a computing machine, to quantify nodularity of the surface of the liver and calculate a liver surface nodularity score.

Abstract: Devices, systems, and methods for monitoring and determining characteristics of wounds on a subject are disclosed. A monitoring device includes an imaging component and a computing device communicatively coupled to the imaging component. The imaging component includes a light emitting component that emits light at a calibrated wavelength, a laser emitting device, and an imaging device. The computing device directs the light emitting component to emit the light at the calibrated wavelength, directs the imaging component to cause the laser emitting device to emit a laser projection toward the wound, receives, from the imaging component, image data captured by the imaging device, determines, from the image data, the characteristics of the wound, and scores the wound based on the characteristics of the wound to obtain a wound score. The characteristics include one or more of a size of the wound, a type of tissue, and an amount of exudate.

Abstract: An apparatus for measuring hard and/or soft tissue abnormalities incidental to dental and/or systemic disease is provided. The apparatus includes a diagnostic device configured for transmitting and receiving non-ionizing electromagnetic waves to measure the patient's hard and/or soft tissue abnormalities associated with the underlying hard and/or soft tissue. The diagnostic device may include at least one of a stent and a diagnostic probe, connected to a computer. The diagnostic device is configured to transmit and receive the electromagnetic waves, and the computer is configured for measure the bone density and/or bone vascular perfusion adjacent and across the patient's hard and/or soft tissue. A method for measuring hard and/or soft tissue abnormalities incidental to dental and/or systemic disease is also provided.

Abstract: A device for measuring spinal stiffness comprises a frame-work supporting a roller that is rolled over the surface of the back. The device creates and records a trajectory across a subject, using a control board and the roller, and moves the roller along the trajectory while applying a force to the subject using the roller and records displacement of the object in the direction of the force. A stiffness map is created using displacement as a function of force. Motors may be used to move the roller through three axes.

Abstract: The present disclosure pertains to facilitating sleep improvement for a user. In a non-limiting embodiment, user data associated with a sleep session of a user is received from one or more sensors. Based on the user data, one or more sleep metrics associated with the sleep session are generated. One or more reference sleep metrics are determined based on prior user data obtained from one or more prior sleep sessions. One or more immediate values related to the sleep session is/are determined based on a comparison of the sleep metrics with the reference sleep metrics. A sleep session score value is generated based on the immediate values, and the sleep session score value and the sleep metrics are caused to be presented on via an output device.

Abstract: An automated adaptive muscle stimulation system and method are disclosed. The stimulation system includes at least one electrode assembly adapted to deliver a muscle stimulation signal to the tissue of a user, a sensor system adapted to detect a muscle response, and an electrical stimulation device operably coupled to the at least on electrode assembly and the sensor system, the electrical stimulation device including a control system operable to automatically diagnose at least one characteristic of a muscle from the detected muscle response and adjust at least one parameter of the muscle stimulation signal in response thereto to deliver an adjusted muscle stimulation signal. A dual mode muscle stimulation system adapted to accept first and second data sets and provide first and second levels of treatment data is also disclosed.

Abstract: Systems and methods for treating a medical condition such as worsening heart failure (WHF) are described. A medical system may sense one or more physiological signals, and generate from the sensed physiological signals a signal metric trend indicating a progression of heart failure. A detector may detect a physiological event leading to WHF. A therapy control circuit may generate a therapy titration protocol using the generated signal metric trend. The therapy titration protocol includes a temporal profile of therapy dosage relative to a target dosage. The therapy control circuit may adjust the target dosage based on patient response. Therapies may be administered by a clinician or automatically delivered to the patient according to the therapy titration protocol.