Patent Description:
Sleep disordered breathing which results in the diagnosis of Obstructive Sleep Apnea ("OSA") occurs as a result of a partial or complete collapse of the upper airway during sleep. Snoring is the first indication of an airway susceptible to collapse and can lead to inspiratory flow limitation. Greater obstruction resulting in a partial collapse of the airway causes hypopneas and recognizable changes in tidal volume. Full collapse results in a cessation in breathing, events commonly referred to as apneas. The apnea/hypopnea index (AHI) is the measure used to define OSA severity and is based on the total number of sleep disordered breathing events per hour of sleep.

When a patient with OSA is in the supine position, gravity increases the susceptibility of the airway to partial or full collapse during sleep. The most frequently cited effect of gravity on the soft tissue of the pharynx is tendency of the tongue to fall back against the palate causing the narrowing of an already compromised airway. A susceptible airway, by way of example, may result in loud snoring in the supine position and limited or no snoring the non-supine position. A more compromised airway may exhibit loud snoring in the non-supine position and repeated hypopneas (partial collapse) or apneas (full collapse) in the supine position. This pattern is typically associated with patients with 'positional' sleep disordered breathing. In patients with severely compromised airways, known as 'non-positional' OSA, the pharynx may partially collapse during non-supine sleep and fully collapses in the supine position. The influence of gravity during supine sleep contributes to a reduction in lung volume and oxygen stores and contributes to increased levels of oxygen desaturation during obstructive breathing.

Evidence suggest that patients with positional and non-positional OSA form two distinct but overlapping etiologies in which airway length and craniofacial features influence genioglossal responsiveness to negative pressure pulses in the lateral position. Estimate of the prevalence of positional OSA (i.e., the supine AHI is at least two times greater than the non-supine AHI) among all those diagnosed with OSA range from <NUM> to <NUM>%), and after excluding those who sleep almost exclusively on their back (e.g., > <NUM>% of the night), over <NUM>% of patients diagnosed with sleep could reduce their AHI by at least <NUM>% and/or into a normal range by avoiding sleep in the supine position. Studies have shown that position therapy can contribute to a significant drop in blood pressure in patients with Obstructive Sleep Apnea (OSA) because supine sleep increases the severity of OSA. Position therapy can be combined with other therapies to enhance outcomes in the treatment of sleep disordered breathing. Several investigators have demonstrated nasal continuous positive airway pressure (CPAP) pressures can be reduced if patients sleep lateral instead of supine and increased CPAP compliance has been associated with lower pressures.

A plethora of shirts, vests, belts, pillows and other inventions have attempted to address the need for positional therapy to reduce the severity of snoring or sleep apnea by using mechanical means that essentially makes it uncomfortable for a user to sleep supine. Some examples of these devices include a knapsack stuffed with Styrofoam to provide a bulky alternative to tennis balls, which makes it impossible to sleep supine. At least one study has demonstrated that this type of position restriction provides limited to no clinical efficacy due to non-compliance. The greatest limitation of these approaches is that the therapy is initiated prior to the patient falling asleep. As shown with CPAP therapy, patients are much more tolerant of therapy if it is initiated after the patients have fallen asleep.

The number of electronic devices invented to limit supine sleep is substantially less. One device, described in <CIT>, employs the use of two gravity position sensors and an audio alarm to trigger the user to change position. One of the limitations of this approach is a bed-partner of the user would also be awakened each time the alarm is triggered. An alternative approach, described in <CIT>, limits supine sleep by applying electromechanical vibration using motors inserted into pockets of a belt worn by a user. Application of the tactile stimulus is dependent on the closing of an electronic switch within the pocket of the belt that is triggered by contact with the underlying surface of the sleeper.

Positional therapy holds the potential to provide important therapeutic benefit for a number of medical conditions. For example, over <NUM>% of patients with acute ischemic stroke sleep the entire night in the supine position. Sleep in the supine position also increases the severity of Cheyne-Stokes i.e., respiration i.e., central sleep apnea. Avoiding supine sleep during the second and third trimesters of pregnancy would reduce pressure on a vena cava vein and improve blood flow to the fetus. An adjustment in the application of position feedback would assist patients recovering from hip surgery avoid sleep in the non-supine position. The measurement of and feedback related to the position of the elements of the body (e.g., arm, leg, hand, wrist, ankle, knee, etc.) could be useful in injury rehabilitation or in training or performance which requires the user to find or maintain a specific position/posture. Thus, the potential benefit of positional therapy is clear, but conventional systems and methods to affect or influence sleep position have been largely ineffective.

The invention sets out a wearable position therapy device according to claim <NUM>.

Systems for controlling the position of a user of a wearable positional therapy device are provided. In one arrangement, the wearable position therapy device is configured to monitor and store physiological signals that can be used to assess sleep quality and sleeping position of a user as well as during other activities. The device can be configured to be worn around the head, the neck, or body of the user and/or can comprise of more than one unit that are connected wirelessly to share information. The device can be configured to provide feedback to a user if the user is sleeping or is positioned in a target position to induce the user to change positions. For example, the device can be configured to limit the amount of time that the user spends sleeping in a supine position for users for whom it is not recommended to sleep in a supine position, such as OSA patients and users who are pregnant. The feedback can be provided by one or more haptic motors that can be configured to provide various levels of feedback and the level of feedback can be customized based on the user's reaction to the feedback.

In an arrangement, a wearable position therapy device for influencing the position of a user is provided. The device includes a position detector configured to generate positional signal data that can be used to determine a position of the user, a haptic feedback device configured to generate tactile feedback to the user of the device, and a microcontroller. The microcontroller is configured to receive and analyze the signal data from the position detector, determine whether the user of the device is in a target position, and generate a control signal to cause the haptic feedback device to provide tactile feedback to the user to induce the user to change to a different, non-target position if the user of the device is in a target position. In an arrangement, the position therapy device can be configured to influence a sleeping position of a user and can be worn while the user sleeps. The target position can be a target sleep position, and the microcontroller can be configured to generate a control signal to cause the haptic feedback device to provide tactile feedback to the user to induce the user to change to a different, non-target sleep position if the user of the device is in a target sleep position.

A method for influencing the position of a user using a wearable position therapy device is provided; however, such a method is not part of the claimed invention. The method includes applying the position therapy devices to the head, neck, body, torso, hand, wrist or knee of the user, collecting positional signal data to determine a position and manner of the user while the user is wearing the device, determining whether the positional signal data indicates that the user is positioned in a target position, and generating haptic feedback to the user to induce the user to change to a different, non-target position if the user is in the target position. The method can be used to influence a sleeping position of a user of the wearable position therapy device, and the positional signal data can be used to determine whether the user is in a target sleep position, and to provide haptic feedback to the user if the user is in the target sleep position to influence the user to change to a different, non-target sleep position.

Systems and methods for influence position of a user are provided; however, such methods are not part of the claimed invention. Embodiments can be used to control the influence the position of a user's body, and some embodiments can be used to influence a sleeping position of the user. The device can be configured to be worn around the head, the neck, or body of the user. The device can be configured to provide feedback to a user if the user is sleeping or is positioned in a target position to induce the user to change positions. For example, the device can be configured to limit the amount of time that the user spends sleeping in a supine position for users for whom it is not recommended to sleep in a supine position, such as OSA patients and users who are pregnant. The feedback can be provided by one or more haptic motors that can be configured to provide various levels of feedback and the level of feedback can be customized based on the user's reaction to the feedback.

According to one arrangement, a wearable position therapy device is provided that is configured to monitor and store physiological signals that can be used to assess sleep quality and sleeping position of a user. The device can be worn around the head, the neck, or body of the user. The device can be configured to provide haptic feedback to induce the user change sleeping positions if the position therapy device determines that the user is sleeping in a target position. In an arrangement, the form factor of the device is comfortable so as to not disturb the user's ability to sleep while wearing the device. The device is also easy for a user to self-apply. The device can be configured to provide feedback, including haptic feedback, to influence the user's sleep positions. Adaptive feedback routines can be included to minimize the disruption of sleep continuity while reducing the likelihood that the user does not return to the target sleep position. The application of feedback can be provisionally set so the device can worn to first obtain baseline sleep data for comparison to the changes in sleep position after initiation of feedback. The signals recorded during the night(s) can be analyzed to assess parameters useful in assessing treatment compliance and efficacy, such as total sleep time and sleep efficiency, snoring frequency and loudness, and percentage of sleep time by position.

Embodiments and arrangements of the position therapy device can also be used in applications where the user is not sleeping but it is desirable for the user to avoid specific positions. For example, a pregnant user experiencing pre-eclampsia might be confined to bed rest by a physician and instructed to avoid laying in a supine position when both asleep and awake in order to avoid aggravating the condition.

According to an arrangement, the target position can also be defined as a position that the position therapy device will discourage the user from being in that position. In some arrangements, a set of allowable positions can be defined and if the user moves to a position that is not included in the set of allowable positions that position can be considered a target position, and the position therapy device can be configured to provide feedback to the user to induce the user to change positions to one of the allowed positions. This approach can be useful in teaching or training exercises where the position therapy device can be used to train a user to be in a certain position.

<FIG> is a block diagram identifying functional components and circuits of a Position Therapy Device ("PTD") <NUM> according to an embodiment. The PTD <NUM> can be configured to be worn on the head, neck, or body of a user. In some arrangements, the PTD <NUM> can be worn during sleep to influence the position of the user's body. In other arrangements, the PTD <NUM> can be worn while the user is awake to provide feedback to the user if the user positions his or her body in a predetermined target position to be avoided. In an arrangement, the PTD <NUM> includes a microcontroller <NUM>, a haptic feedback device <NUM>, power supply <NUM>, battery <NUM>, recharging circuit <NUM>, and position detector <NUM>. <FIG> illustrates the various components of the PTD <NUM> as being in communication with one another. The components can be in communication with one another via a wired or wireless connection.

The position detector <NUM> is configured to generate signal data that can be analyzed by the PTD <NUM> to determine the sleeping position of the user. For example, the position detector <NUM> can be used to determine whether the user is in a supine position. According to an arrangement, the position detector <NUM> can comprise an accelerometer. According to an alternative arrangement, a pressure switch or sensor can be used instead of an accelerometer. When the PTD <NUM> is worn on the user's the neck or against the user's back, the pressure switch or sensor can be used to detect when the user is sleeping or laying in a supine position.

According to an embodiment, the PTD <NUM> can include a microphone <NUM> that can be configured to capture audio data while the user is sleeping. This audio data can be analyzed by the PTD <NUM> to detect snoring and/or other audible symptoms that can be causing sleep disruption. Snoring can be an indicator of obstructed breathing, and the PTD <NUM> can be used in a therapy regime for OSA in which a user is discouraged from sleeping in a supine position. In an example, microphone <NUM> can be used to capture audio signals to assess snoring magnitude and frequency, which are likely to be position dependent. In a preferred arrangement an acoustic microphone is used to obtain quantified levels of snoring. In an alternative arrangement, a vibration microphone can be used instead of an acoustic microphone. In an arrangement, the PTD <NUM> can be configured to correlate the audio data captured by microphone <NUM> with positional data generated by the position detector <NUM> to determine whether to provide haptic and/or audiovisual feedback to the user to induce the user to shift to a different sleep position. For example, a user having OSA can be induced to sleep in a non-supine position if severe snoring is detected by the PTD <NUM>.

In the embodiment illustrated in <FIG>, the PTD <NUM> includes a power component <NUM> that includes a rechargeable battery <NUM> and a power supply <NUM> for receiving power from an external source for recharging battery <NUM> via recharging circuit <NUM> and/or powering the PTD <NUM>. The battery <NUM> allows the PTD <NUM> to operate without requiring the PTD <NUM> to be tethered to an external power cord or power supply, which could be inconvenient and uncomfortable for a user of the device. In the preferred arrangement, the battery capacity is sufficient to allow the PTD <NUM> to acquire data from multiple nights while providing the required haptic feedback to the user.

In one arrangement, battery <NUM> can be a rechargeable lithium polymer battery. According to other arrangements, battery <NUM> can be another type of battery, either rechargeable or non-rechargeable, and in some arrangements, battery <NUM> can be removable and replaceable. According to one arrangement, battery <NUM> is a rechargeable battery that includes a micro-USB connector that allows battery <NUM> to be recharged using a standard USB charger that plugs into an electrical outlet or a standard USB host. In an arrangement, the recharging circuit <NUM> comprises a standard USB wall charger that plugs into a standard wall outlet in order to power the PTD <NUM> and/or recharge battery <NUM> using mains power. According to some arrangements, an external power supply can be used to power the device.

The PTD <NUM> can include a memory <NUM> for data storage. In an arrangement, the memory <NUM> can comprise a removable Multimedia Memory card (MMC) or Secure Digital card (SD) car or other types of removable persistent memory. In another arrangement, the memory <NUM> can comprise a fixed flash chip. According to an arrangement, a data transfer interface <NUM> is provided. According to an arrangement, the data transfer interface <NUM> can comprise a micro-USB or similar type of connector that can be used facilitate downloading data from the PTD to an external computer system or web portal, for uploading firmware executable by microcontroller <NUM> to memory <NUM>, or both. In an arrangement, the data transfer interface <NUM> can also include a mechanical interface for providing power to the recharging component <NUM> to recharge the battery <NUM>.

According to an arrangement, most commercially available microcontrollers or microprocessor <NUM> would be appropriate for the PTD <NUM>. However, in a preferred arrangement, the microcontroller <NUM> is an inexpensive, small, low-powered chip. The PTD <NUM> can include firmware executable by the microcontroller <NUM>. The firmware can be stored in data storage <NUM> or in a flash memory of microcontroller <NUM>. According to some arrangements, the firmware can be updated by downloading new firmware from an external computer system via data transfer interface <NUM>.

According to an arrangement, the firmware can be configured to minimize the power requirements of the microcontroller <NUM> while the PTD <NUM> is being used in recording mode to capture data from the position detector <NUM>, the microphone <NUM>, and/or other sensors. The firmware can be configured to analyze data received from the position detector <NUM>, microphone <NUM>, and/or other sensors and to provide feedback to the user of the device via audiovisual output module <NUM> and/or haptic feedback device <NUM> for providing tactile feedback to the user of the PTD <NUM>. In an arrangement, the haptic feedback device can comprise one or more haptic motors for providing tactile feedback to the user of the PTD <NUM>. In an arrangement, the PTD <NUM> can be configured to store various position therapy (PDT) data to the memory <NUM>. The PDT data can include data received from the position detector <NUM> and/or the microphone <NUM>. The PDT data can include data, such as the sleep position at various times, the changes to the sleep position of the user, sleep state and arousals, snoring data, and/or other data that can be recorded and/or generated by the PDT <NUM>.

In an arrangement, the PTD <NUM> can be configured to store various position therapy (PDT) data to the memory <NUM>. The PDT data can include data received from the position detector <NUM> and/or the microphone <NUM>. The PDT data can include data, such as the sleep position at various times, the changes to the sleep position of the user, sleep state and arousals, snoring data, and/or other data that can be recorded and/or generated by the PDT <NUM>.

According to an arrangement, the PTD <NUM> can be configured to write an action history to the memory <NUM> to assist customer service support. For example, information regarding when the battery <NUM> of the PTD <NUM> has been charged, when the device has been powered on and off, when the device has started and stopped recording sleep assessment data about the user, and other information can be included in the action history that is written to memory <NUM>.

In an arrangement, the data transfer interface comprises a Universal Serial Bus (USB) data transfer chip to facilitate transferring of data captured by the PTD <NUM> to an external computer system or web portal. In another arrangement, USB transfer capabilities can be incorporated into microcontroller <NUM>.

The memory <NUM> can be used to store data collected by the PTD <NUM> while the device is being worn by a user. Alternatively, this information can be stored to the flash of the microcontroller <NUM>. To avoid data loss when saving to flash memory, the firmware can identify when the battery power is low and can conserve power until the data is downloaded.

In an arrangement, to improve the ease and speed of transfer of files from the data storage device, a USB flash drive chip can be included in the PTD <NUM>. In some arrangements, the capability to transfer data via USB or native USB is provided by the microcontroller <NUM>. According to an arrangement, the PTD <NUM> can be connected to an external computer system via a USB connection, and the PTD <NUM> can be recognized as a USB Human Interface device, which can allow direct control of the device by the Microsoft Windows operating system and/or by Web-based software.

In an arrangement, the PTD <NUM> includes one or more haptic motors <NUM> that can be configured to elicit vibrations in response to control signals from the to provide haptic feedback to the user when the PTD <NUM> recognizes that the user is in the target position. The haptic feedback can be used to alert the user that the user needs to change positions from the target position. In one arrangement, an electronic feedback module that is configured to provide electrical stimulation to the user in response to control signals from the microcontroller can be used instead of haptic feedback in order to influence the sleep position of the user. In one arrangement, an audio emitter can used as an alternative to or in addition to haptic feedback to influence sleep position.

According to an arrangement, in order to improve the ease of use of PTD <NUM>, audiovisual output module <NUM> can be used as a means to communicate with the user. In one arrangement, voice messages can be provided via an audio circuit or speaker to provide feedback to user. For example, a voice message might be provided to indicate that the PTD <NUM> has slipped out of position or has fallen off. In another example, a voice message might be provided to indicate that the battery <NUM> is low or that the PTD <NUM> is running out of memory for storing data. One skilled in the art will recognize that other types of audio messages can be provided to user of the device to facilitate use of the device. In an alternative arrangement, an audio emitter can be used to project audio patterns that the user can be trained to recognize. For example, the audio emitter could be configured to emit a specific signal if the device is turned on or if the device has fallen off.

According to another arrangement, a light emitting diode (LED) can be used to identify when the PTD <NUM> is powered on, when the battery <NUM> is being charged, or alternatively when the battery <NUM> needs to be recharged, or when data is available for transfer from the PTD <NUM> or when data is being transferred from the PTD <NUM>. In another arrangement, a display can be provided for displaying text messages, icons, or other visual indicators to the user regarding the operation of usages of the device. For example, the PTD <NUM> can include a liquid crystal (LCD) display, an LED display, or an organic light emitting diode (OLED) display for displaying information to the user of the device. One skilled in the art will recognize that microcontroller and firmware provides the means to apply any number of notifications or feedback using various combinations audio and visual feedback.

According to an arrangement, the PTD <NUM> can comprise low profile chips to minimize the profile of the PTD <NUM>. For example, low profile chips can be used to implement microcontroller <NUM>, position detector <NUM> (e.g., an accelerometer). In one arrangement, microcontroller <NUM>, flash memory for data storage <NUM>, and a USB chip for data transfer interface <NUM> can be mounted on a printed circuit board (PCB), and a triple-axis accelerometer for position detector <NUM> can be centered on the top of the PCB. Connectors for battery <NUM>, haptic motor <NUM>, a mini-USB connector for data transfer interface <NUM>, light emitting diodes for audiovisual output module <NUM>, and an on-off switch can be mounted on the bottom of the PCB. Passive components can be mounted in the available space around these components.

According to an arrangement, the on-off switch can be located where the user can readily switch on the PTD <NUM>, but the switch can be sufficiently recessed so that the device cannot easily be inadvertently turned off during use (e.g., by catching the switch on bedding or a pillow or the user's head or body). Because the haptic motor utilizes can use a substantial amount of current, the number of nights of use for a given size battery prior to recharging can depend on how often the haptic motor is used to provide feedback to the user. In a preferred arrangement, haptic motor <NUM> is physically located within the enclosure of the PTD <NUM> such that the haptic motor <NUM> can transmit a maximum level of vibration with a minimal amount of power consumption.

<FIG> is a flow diagram of a method for using the PTD <NUM> to monitor and control the sleep position of a user. As described above, the PTD <NUM> can be self-applied by a user and can be positioned on the head, neck, or body and is worn by the user during sleep.

Once the PTD <NUM> has been applied by the user, the PTD <NUM> can use a set of algorithms included in the firmware executed by microcontroller <NUM> to assess data collected by the position detector <NUM> to assess the sleeping position of the user (step <NUM>). According to an arrangement, the position detector <NUM> comprises one or more accelerometers that can be used to assess the sleep position of the user. The PTD <NUM> monitors data received from the position detector <NUM> in order to make real-time assessments of the sleep position of the user. As described above, the PTD <NUM> can also include a microphone <NUM> that can be used to capture audio signals indicative of whether the user is snoring. In an arrangement, the audio data captured by microphone <NUM> can be analyzed by the firmware to determine whether the user is snoring, and the microcontroller <NUM> can write the data to data storage <NUM>. In one arrangement, the audio data captured by the microcontroller <NUM> can be written to the data storage <NUM> and the stored audio data can be transferred from the PTD <NUM> to an external computer system for further analysis and processing. In some arrangements, the microcontroller <NUM> can be configured to execute one or more analysis algorithms implemented in the firmware on the data received from the microphone <NUM> to identify whether the user of the device is snoring. The microcontroller <NUM> can also be configured to write snoring event data to the data storage <NUM>, and the stored snoring event data can later be transferred to an external computer system or web portal for further analysis and processing.

A determination is made whether a target sleep position is detected based on the assessment of the data from the position detector <NUM> (step <NUM>). The target sleep position is a sleep position to be avoided. For example, the target sleep position for a patient with OSA may be a supine position, because sleeping on the back can cause the airway to be susceptible to collapse and can lead to inspiratory flow limitation. If the target position is the supine position and the PTD <NUM> determines that the user is sleeping in the target position, the PTD <NUM> can provide haptic feedback to the user (step <NUM>) to influence the user's sleep position. For example, if the user is sleeping in a supine position and the target position is the supine position, haptic feedback can be provided to encourage the user to change position. According to an arrangement, haptic feedback can be elicited until the PTD <NUM> detects that the user has changed position.

According to an arrangement, the PTD <NUM> can be worn for multiple nights between battery charges and over the course of the multiple nights, the PTD <NUM> can monitor compliance, the impact of the feedback on sleep continuity, behavioral arousals and sleep efficacy, and snoring.

The method illustrated in <FIG> can be adapted for use with users who are using the PTD <NUM> while awake. For example, the PTD <NUM> can be used to assess the position of the user (step <NUM>) who is awake and to determine whether the user is in a target position (step <NUM>) and provide haptic feedback to the user (step <NUM>). For example, the PTD <NUM> could be used by a pregnant user to warn the user to avoid lying down in a supine position. In another example, the PTD <NUM> could be used to warn a patient with an arm or shoulder injury from lying on the injured side of the body.

Alternatively, the PTD <NUM> can be used to assist a person locate or avoid the appropriate position. For example, the precise position of the head, neck body or torso may be important for use in the rehabilitation of in injury. Haptic feedback can be used for positive reinforcement when a particular position is achieved, or for negative reinforcement, as described previously to avoid a particular position.

<FIG> illustrates an alternative embodiment of the position therapy device illustrated in <FIG> that includes a wireless transceiver. The wireless arrangement of the PTD <NUM> illustrated in <FIG> can be used with any of various methods described herein in which the non-wireless version of the PTD <NUM> can be used. The arrangement of PTD <NUM> illustrated in <FIG> can remotely monitor the position of the user's body and provide haptic feedback to the user. The components of the PTD <NUM> illustrated in <FIG> are similar to those of <FIG>, but the embodiment illustrated in <FIG> includes a wireless transceiver <NUM> that can be configured to allow the PTD <NUM> to communicate with one more remote position sensors <NUM>. According to an arrangement, the wireless transceiver can be a Bluetooth transceiver, a Zigbee transceiver, or other type of wireless transceiver that can provide wireless communications between the PTD <NUM> and the remote position sensor <NUM>. <FIG> illustrates the various components of the PTD <NUM> as being in communication with one another. The components can be in communication with one another via a wired or wireless connection.

The remote position sensor <NUM> includes a microcontroller <NUM>, a position sensor <NUM>, and a wireless transceiver <NUM>. In an arrangement, the microcontroller <NUM> can be similar to microcontroller <NUM> of PTD <NUM> or can be of a different configuration. Position detector <NUM> can also be of a similar configuration as position detector <NUM> of PTD <NUM> or can be of a different configuration. In an arrangement, the PTD <NUM> can also include the wireless position detector <NUM> when the remote position sensor <NUM> is used, while in other arrangements, the PTD <NUM> can be configured to not include a wireless position sensor <NUM> when one or more wireless position sensors <NUM> are used.

Information collected by the remote position sensor <NUM> can be transmitted to the PTD <NUM>. The microcontroller <NUM> can use this information to determine whether to generate a control signal to provide haptic feedback to the user with haptic feedback module <NUM>.

In an arrangement, the remote sensor <NUM> can include a power supply <NUM>, battery <NUM>, and recharging circuit <NUM> similar to that of PTD <NUM>. In other arrangements, the remote sensor <NUM> can include a non-rechargeable, replaceable battery to provide power to the remote sensor.

In one arrangement, more than one remote position sensors <NUM> can be used to provide information relating a position or positions of the head, torso, or extremities of a user. One skilled in the art will recognize the potential benefit of an athlete having multiple remote position sensors attached to key aspects of his body to ensure complex positions are maintained prior to execution of an action (e.g., preparing to hit a baseball, drive or put a golf ball, shoot a free throw, etc.). This approach allows for position information obtained during performance modeling, video taping, etc. to be translated to positions or angles of the body or extremities and in which haptic feedback can be used to assist the user to achieve that exact position (or similar position) during practice without access to the more sophisticated measurement approaches. In one arrangement the one or more remote sensors can be attached or woven into clothing, a glove(s), wristbands, socks, etc. to allow more accurate placement of the sensor relative to a part of the user's body. In one arrangement, multiple remote sensors <NUM> can be attached or incorporated into a garment or accessory, allowing more than one sensor to share use the same battery and/or transceiver. In one arrangement, an energy-harvesting module can be used to provide power to the battery of the remote sensor <NUM> and/or the PTD <NUM>. The energy-harvesting module can generate power based on movements of the user during the use of the PTD <NUM>.

In an alternative arrangement, the remote sensor <NUM> can be connected to the PTD <NUM> using a wired interface, and the PTD <NUM> and the remote sensor <NUM> can include appropriate physical interfaces for the wired connection. For example, in an arrangement, the remote sensor <NUM> and the PTD <NUM> can include data ports into which a data cable can be plugged to provide a wired communication connection between the remote sensor <NUM> and the PTD <NUM>.

<FIG> illustrates another method for monitoring and influencing the sleep position of PTD <NUM> using conditional positional feedback. The method illustrated in <FIG> is similar to that of <FIG>, but the method illustrated in <FIG> is adapted to assist sleepers that have difficulty falling asleep in a position other than the target position. For example, the method illustrated in <FIG> can be used to assist predominantly supine sleepers that may have difficulty falling asleep on their sides by allowing the user to initially fall asleep in a supine position. The method provides the patient with an opportunity to fall asleep before using conditional feedback to influence the sleep position of the patient. This approach avoids compromising the sleep efficiency of the user by forcing the user to attempt to fall asleep in a non-target position when the user is typically unable to fall asleep in a non-target position. For example, if a user who is typically a supine sleeper will not be forced to attempt to fall asleep on her side.

As described above, the PTD <NUM> can be self-applied by a user and can be positioned on the head, neck, or body and is worn by the user during sleep. Once the PTD <NUM> has been applied by the user, the PTD <NUM> can use a set of algorithms included in the firmware executed by microcontroller <NUM> to assess data collected by the position detector <NUM> to assess the sleeping position of the user (step <NUM>). A determination can then be made whether the user has had a sufficient amount of time in bed to make an assessment (step <NUM>). Positional feedback will be initiated only after a predetermined or configurable elapsed time period with the PTD <NUM> on (e.g., <NUM>-minutes). For example, in some arrangements, the user and/or a doctor or therapist treating the patient can configure the amount of time that PTD <NUM> will wait before making an initial assessment, while in other arrangements, the PTD <NUM> can be configured to wait for a predetermined time period before making an initial assessment. If the user has not had a sufficient amount of time in bed prior to making an assessment, the method returns to step <NUM> where a new assessment can be made.

Otherwise, if the predetermined or configurable time period has elapsed a determination can be made whether movement is detected (step <NUM>). For example, the user is moving his or her head or other parts of the body, then the user may still be awake. If movement is detected, the user is likely not to be asleep and positional feedback would not be effective. Therefore, the method returns to step <NUM> where a new assessment can be made.

According to the invention, a user can reset the time period on the PTD <NUM> if the user has trouble falling asleep. For example, a user might be awakened during the night by the need to use the bathroom, and upon returning from the nocturnal use of the bathroom, the user can turn the PTD <NUM> off and then back on in order to reset the feedback delay. The microcontroller <NUM> can include a real-time clock that can be used to timestamp the on/off mark in the data captured by the PTD <NUM> so that the data can be appended into a single of information when a compliance and efficacy report is generated from the data.

Otherwise, if no movement is detected, then the user is more likely to be asleep, and a determination can be made whether snoring is detected (step <NUM>). As described above, the PTD <NUM> can include a microphone <NUM> that can be used to capture an audio signal that can be analyzed to determine whether the user is snoring. While lack of snoring is not indicative of whether the user is asleep, snoring is indicative that the user is asleep and can also be indicative of an airway susceptible to collapse and can lead to inspiratory flow limitation. If no snoring is detected, the user may not be sleeping, and thus positional feedback could be counterproductive. If the user is asleep and is not snoring, the user is likely to be in a non-target position (in this example, a non-supine position), and applying positional feedback might simply wake the user. Otherwise, if the user is not asleep, applying positional feedback could prevent the user from falling asleep. Therefore, the method returns to step <NUM> where a new assessment can be made.

Step <NUM> can be optional if the user has satisfied the conditions of steps <NUM> and <NUM> and has been in bed for a sufficient amount of time and no movement has been detected. In some arrangements, the PTD <NUM> can be configured to track how much time has passed since the movement was detected in step <NUM>, and if a predetermined period of time has passed since the last movement was detected, the method can proceed to step <NUM> even if no snoring is detected. For example, in one arrangement, if the user has been in bed for at least <NUM> minutes, the condition of step <NUM> is satisfied. No movement is detected at step <NUM> so the step is also satisfied, but if no snoring is detected, the method would return to step <NUM> even thought the user might be asleep. Therefore, the PTD <NUM> can begin keeping track of how long it has been since movement was last detected (or when step <NUM> was first performed if no movement has been detected since the method began), and if a predetermined time period (e.g., five minutes) passes an no movement is detected and no snoring is present, the method can proceed to step <NUM>, because it is likely that the user is asleep but is not snoring.

Furthermore, in an alternative arrangement, if snoring is detected even if some movement is present, the snoring is indicative that the user is asleep, and the method can proceed to step <NUM>. The order of steps <NUM> and <NUM> can be reversed, so that the PTD <NUM> is configured to check for snoring before checking for user movements.

A determination can be made whether the user is in a supine position for arrangements where the target position is a supine position (step <NUM>). According to an arrangement, a determination could be made whether the user is in other non-supine target positions depending upon the individual needs of the user and the condition for which the user is being treated. If the user is in the target position, haptic feedback can be provided to the user (step <NUM>). In a preferred arrangement, once the user is asleep, feedback is provided immediately after a position change so as to not alter or disrupt the continuity of sleep more than what would normally occur when a sleeper changes position. In an arrangement, the position detector <NUM> can be used to detect that the user has changed position. For example, in one arrangement, the position detector <NUM> comprises one or more accelerometers that can be used to determine that the user's body position.

In one arrangement, the feedback stimulation routine begins at a low intensity level two-second haptic feedback interval when the supine position is detected. After applying the feedback to the user, an assessment can then be performed on data collected by the position detector <NUM> to assess the sleeping position of the user (step <NUM>), and a determination can be made whether the user is in a supine position (step <NUM>). According to an arrangement, if gross movement of the user's body position is not identified, an additional feedback routine sequence can be applied. For example, in an arrangement, if the PTD <NUM> does not detect that the patient has begun to change position within four seconds of the termination of the previous feedback routine, another <NUM> second long feedback routing can be presented at a higher intensity level than the previous feedback routine. The sequence of steps <NUM>, <NUM>, and <NUM> can be repeated until the user finally changes positions and settles into a non-supine position <NUM>.

According to an arrangement, the PTD <NUM> can also be configured to store the data received from the position detector <NUM> and the microphone <NUM> (step <NUM>). According to an arrangement, the data received by the microphone <NUM> can be analyzed by the PTD <NUM> to determine whether the user is snoring, and data indicating whether the user was snoring and a particular data and time can be stored in the data storage <NUM>. According to an arrangement, other data can also be collected by the PTD <NUM> and stored in the data storage <NUM>. For example, the PDT <NUM> can configured to determine a current sleep state of the user, a current sleep position of the user, feedback that was provided to the user, and/or other information that can be used to determine the quality of the user's sleep and the efficacy of the PTD treatment.

According to an arrangement, the final intensity of the haptic feedback provided to the user that resulted in the user changing position can be saved to data storage <NUM> and can be used as a starting level for the haptic feedback provided the next time that feedback is required. The patterns of haptic feedback described above are merely one example of the pattern of feedback that can be used to influence the sleeping of the user. In other arrangements, different patterns of haptic feedback including different haptic feedback intervals and lengths of pauses between intervals of increasing intensity of feedback can be used. According to an arrangement, a different number of haptic motors <NUM> can also be used to create a subjective perception of increased levels of feedback.

According to an arrangement, the firmware of PTD <NUM> can be configured to store data representing the average feedback intensity levels and range of feedback intensity levels required to initiate position changes. This data can be stored in data storage <NUM>, and the PTD <NUM> can utilize this information the next time the PTD <NUM> is used to establish the initial feedback pattern. Thus, the patterns and intensity of the feedback can be tailored to the individual user in order to encourage positional behavior without over-stimulation. For example, by using the techniques described above, the PTD <NUM> will not stimulate a light sleeper fully awake, and the PTD <NUM> won't under stimulate a heavy sleeper, such that the feedback produced by the PTD <NUM> is ignored.

The feedback intensity is adaptive so that the therapy can also be efficacious in patients who are taking analgesic medications, sleeping pills, or consuming alcohol prior to bed. The conditional algorithms can accommodate changes in the user's sensitivity to the feedback based on sleep stage or adaptation to continued use of the PTD <NUM>. PTD <NUM> can be configured to use various numbers of feedback intensity levels, as well as various lengths of the feedback and durations between feedback events without negatively impacting the functionality of the PTD <NUM>.

According to an arrangement, the position detector <NUM> comprise accelerometers that are sensitive enough provide data that can be used to monitor the breathing of the user. The breathing pattern of the user can be collected as part of the position therapy data collected by the PTD <NUM> and can be used to identify interruptions and arousals in the sleep pattern of the user. For example, in an OSA patient, the patient's breathing can be interrupted resulting in the patient gasping for air. The data collected by the accelerometers can be analyzed to identify such events. The breathing data collected by the PTD <NUM> can also be used in determining whether the user is asleep, and can in some arrangements, be used in addition to or instead of the detection of user movement in step <NUM>. For example, the user's breathing pattern can change when the user falls asleep and this change in breathing pattern can be identified in real time by monitoring and analyzing the signal data from the accelerometer or accelerometers.

<FIG> illustrates a method for processing the data acquired by the PTD <NUM>. As described above with respect to <FIG> and <FIG>, the PTD <NUM> captures and stores data regarding the sleep state of the user (step <NUM>). In one arrangement, this data can be stored in the data storage <NUM> of the PTD <NUM>. The data acquired by the PTD <NUM> can be transferred to an external computer system or web portal (step <NUM>) for additional processing to assess various parameters useful in assessing compliance and efficacy (step <NUM>). According to one arrangement, the data can be transferred from the PTD <NUM> using the data transfer interface <NUM>. As described above the data transfer interface <NUM> can comprise a USB interface for transferring the data acquired by the PTD <NUM> to an external computer system or a web portal.

The frequency of use of the PTD <NUM>, based on hours per night and nights per week can provide useful measures for assessing the user's compliance with PTD therapy. Other data captured by the PTD <NUM>, such as the response time to positional feedback and length of time, the number of times per night the patient attempts to sleep supine, the total and percentage of time the patients user supine, and whether the user turn the device off in the night to eliminate feedback can also provide useful measures of treatment efficacy. According to an arrangement, the positional signal data from position detector <NUM> of the can represent actigraphic data. Actigraphy is a non-invasive method for monitoring the rest and activity cycles of a patient. The PTD <NUM> can measure the motor activity of the user and this data can be captured and stored by the PTD <NUM> as part of the position therapy data. The motor activity data can be analyzed to measure the behavioral sleep patterns of the user and sleep efficiency. This data can be incorporated into a position therapy report generated for the user. In some arrangements, night to night differences in the amplitude and frequency of snoring are additional measures which can also incorporated into a position therapy report to assist the user or their clinician assess the benefits of the PTD <NUM>.

The external computer system or web portal can generate a report based on the position therapy data collected and/or generated by the PTD <NUM>. The position therapy report position therapy report can assist the user or a clinician to assess the benefits of the positional therapy regime. Once the report has been generated, the report can be downloaded or printed (step <NUM>) or viewed online. <FIG> is an example of a report that can be generated using the data captured by the PTD <NUM>. The example report includes two graphs of data captured by the user device over time. The upper graph portion of the report includes positional data indicating the body position of the user over time. The lower graph illustrates the whether the user was awake or asleep over time and whether the user experienced an arousal event. This report can be downloaded for review by the patient or a clinician to assess the efficacy of the PTD therapy.

According to an arrangement, the PTD <NUM> can be interfaced with an external computer system or web portal to provide additional capabilities for monitoring treatment efficacy. For example, the PTD <NUM> can be configured to record sleep position of the user without applying feedback for a predetermined number period of time, such as one or more nights, to create baseline information about the user's preference for sleeping positions and other sleeping habits. Once the baseline data has been recorded, positional feedback can be initiated. The baseline data can later be compared to data collected after positional feedback has been initiated to determine whether the positional therapy is having an affect on the user's sleep habits.

In some arrangements, the PTD <NUM> can be configured via a user interface provided by the external computer system or web portal. For example, in some arrangements, the user interface is configured to allow the user to select a sleep position that the user wishes to avoid. In an example, the user might configure the PTD <NUM> to avoid the supine position for OSA or for pregnancy, or non-supine sleep for patients with shoulder or arm injuries. According to an arrangement, the user interface can also be configured to allow the user or a clinician to configure other parameters affecting haptic feedback or the algorithms used to make the various determinations described used in the method described above, such as the date and time.

<FIG> illustrates an example embodiment of the PTD <NUM>. In the embodiment illustrated in <FIG>, the PTD <NUM> comprises a small injection-molded silicon enclosure <NUM>. The silicon enclosure <NUM> encapsulates the electronic components of the PTD <NUM> and the enclosure is thick enough to protect the electronic components. A thinner, more comfortable durometer silicone can be used for the enclosure extensions <NUM>. In an arrangement, a thin strip of copper can be molded inside of the extensions to allow the PTD <NUM> to be adjusted to conform to the neck or back of the user and to decrease the likelihood that the PTD <NUM> might accidentally be repositioned during sleep and result in false positive feedback. The silicone enclosure <NUM> and enclosure extensions <NUM> can be easily cleaned and maintained with alcohol.

<FIG> illustrates the PTD <NUM> design illustrated in <FIG> that has been placed around the neck of a user according to an embodiment. In the embodiment illustrated in <FIG>, a thin, round silicone enclosure strap <NUM> holds the enclosure <NUM> of the PTD <NUM> in place round the user's neck. The length of the left and right straps can be adjusted over the enclosure <NUM>. According to an arrangement, a low profile magnetic clasp (not shown), similar to that used in some wrist bracelets, can be used on the front of the strap of the PTD <NUM> to allow the PTD <NUM> to be easily applied or taken off by the user. According to an arrangement, to cover safety concerns regarding wearing a collar during sleep, the strength of the magnet included in the magnetic clasp can be selected to ensure that the magnetic clasp will automatically release in the event that the PTD <NUM> were to get caught in the clothing of the user or the bedding.

<FIG> illustrates another embodiment of the PTD illustrated in <FIG> and <FIG> where the enclosure <NUM> can be worn over the spine and can be held in place with the use of a longer, thicker enclosure strap <NUM> than is used in the embodiments illustrated in <FIG> and <FIG>. The enclosure strap wraps around the chest and over the shoulders of the user to hold the PTD <NUM> in place.

Those of skill in the art will appreciate that the various illustrative modules and method steps described in connection with the above described figures and the embodiments and arrangements disclosed herein can often be implemented as electronic hardware, software, firmware or combinations of the foregoing. To clearly illustrate this interchangeability of hardware and software, various illustrative modules and method steps have been described above generally in terms of their functionality. Skilled persons can implement the described functionality in varying ways for each particular application, but such implementation decisions should not be interpreted as causing a departure from the scope of the invention. In addition, the grouping of functions within a module or step is for ease of description. Specific functions can be moved from one module or step to another without departing from the invention.

Moreover, the various illustrative modules and method steps described in connection with the embodiments and arrangements disclosed herein can be implemented or performed with hardware such as a general purpose processor, a digital signal processor ("DSP"), an application specific integrated circuit ("ASIC"), field programmable gate array ("FPGA") or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. A general-purpose processor is hardware and can be a microprocessor, but in the alternative, the processor can be any hardware processor or controller, microcontroller. A processor can also be implemented as a combination of computing devices, for example, a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.

Additionally, the steps of a method or algorithm described in connection with the embodiments and arrangements disclosed herein can be embodied directly in hardware, in a software module executed by a processor, or in a combination of the two. A software module can reside in computer or controller accessible on computer-readable storage media including RAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, hard disk, a removable disk, a CD-ROM, or any other form of storage medium including a network storage medium. An exemplary storage medium can be coupled to the processor such the processor can read information from, and write information to, the storage medium. In the alternative, the storage medium can be integral to the processor. The processor and the storage medium can also reside in an ASIC.

Claim 1:
A wearable position therapy device (<NUM>) for influencing the position of a user, the device (<NUM>) comprising:
a position detector (<NUM>) configured to generate positional signal data based on a position or movement of the user;
a feedback device (<NUM>) configured to generate a feedback stimuli; and
a microcontroller (<NUM>) in communication with the position detector (<NUM>) and the feedback device, wherein the microcontroller (<NUM>) is configured to:
receive the positional signal data from the position detector (<NUM>),
determine whether the user is in a target position based, at least in part, on the positional signal data, and
generate a control signal to cause the feedback device (<NUM>) to provide the feedback stimulus to the user to induce the user to change to a different, non-target position if the user of the wearable position therapy device is in the target position, characterised in that the feedback stimuli is generated only after a delay period has elapsed in response to the device being turned on or a reset operation.