US20210287564A1 - System and method for bed partner mediated sleep disorder treatment program - Google Patents

System and method for bed partner mediated sleep disorder treatment program Download PDF

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Publication number
US20210287564A1
US20210287564A1 US17/037,929 US202017037929A US2021287564A1 US 20210287564 A1 US20210287564 A1 US 20210287564A1 US 202017037929 A US202017037929 A US 202017037929A US 2021287564 A1 US2021287564 A1 US 2021287564A1
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Prior art keywords
sleep
bed partner
partner
bed
determining
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US17/037,929
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Gaurav TRIVEDI
Benjamin Irwin Shelly
Peter Douglas Hill
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Koninklijke Philips NV
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Koninklijke Philips NV
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Priority to US17/037,929 priority Critical patent/US20210287564A1/en
Assigned to KONINKLIJKE PHILIPS N.V. reassignment KONINKLIJKE PHILIPS N.V. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: SHELLY, BENJAMIN IRWIN, HILL, PETER DOUGLAS, Trivedi, Gaurav
Priority to PCT/EP2021/055979 priority patent/WO2021185640A1/en
Priority to EP21712732.3A priority patent/EP4121975A1/en
Publication of US20210287564A1 publication Critical patent/US20210287564A1/en
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    • GPHYSICS
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    • G09BEDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
    • G09B19/00Teaching not covered by other main groups of this subclass

Definitions

  • the present invention pertains to a sleep disorder treatment program, and, in particular, to a system and method for a bed partner mediated sleep disorder treatment program.
  • insomnia sleep disorders
  • restless legs syndrome sleep disordered breathing disorders
  • sleep disordered breathing disorders such as obstructive sleep apnea (OSA), central sleep apnea (CSA), and other such disorders
  • OSA obstructive sleep apnea
  • CSA central sleep apnea
  • therapy treatment is provided in order to treat such sleep disorders and sleep disordered breathing disorders.
  • an object of the present invention to provide an improved system and method for bed partner mediated sleep disorder treatment program that overcomes the shortcomings of conventional systems and methods for providing sleep disorder treatment programs.
  • This object is achieved according to one embodiment of the present invention by providing a system that includes facilitating therapy with couples working together for perceiving shared positive benefits by treating sleep disorders and/or sleep disordered breathing issues. Spousal influence can greatly influence and motivate the patient in continuing the therapy. Moreover, through monitoring bed partners' sleep using wearable or other data, causal information about whose sleep is affecting whom can be inferred. It is noted that many objective and subjective sources of data/information could be used in order to derive the presence and causality of sleep disorders.
  • under-mattress sensors include under-mattress sensors, in-room audio sensors, app-based sensing (e.g. audio, sonar, or accelerometer-based), or subjective questionnaires or assessments. Users can be prompted to seek diagnosis and treatment for sleep disorder and/or sleep disordered breathing conditions and can be used to help coach around therapy adherence.
  • app-based sensing e.g. audio, sonar, or accelerometer-based
  • subjective questionnaires or assessments Users can be prompted to seek diagnosis and treatment for sleep disorder and/or sleep disordered breathing conditions and can be used to help coach around therapy adherence.
  • an improved method of providing therapy to a first bed partner who sleeps with a second bed partner the general nature of which can be stated as including determining that the first bed partner has a sleep disorder, determining that the second bed partner has a problem with sleep that is at least partially attributable to the sleep disorder of the first bed partner, and at least one of recommending and providing a treatment program or therapy to the first bed partner.
  • an improved apparatus structured to indicate a need for therapy in a first bed partner who sleeps with a second bed partner
  • a processor apparatus comprising a processor and a storage
  • an input apparatus structured to provide input signals to the processor apparatus
  • an output apparatus structured to receive output signals from the processor apparatus
  • the storage having stored therein a number of instructions which, when executed on the processor, cause the apparatus to perform a number of operations
  • the general nature of which can be stated as including determining that the first bed partner has a sleep disorder, determining that the second bed partner has a problem with sleep that is at least partially attributable to the sleep disorder of the first bed partner, and at least one of recommending and providing a treatment program and/or therapy to the first bed partner.
  • FIG. 1 is a schematic depiction of an improved apparatus in accordance with an embodiment of the disclosed and claimed concept
  • FIG. 2 is a schematic depiction of a process flow of an improved method in accordance with an embodiment of the disclosed and claimed concept
  • FIG. 3 is an exemplary questionnaire that can be provided to a patient who may have a need for breathing therapy
  • FIG. 4 is an exemplary questionnaire that can be provided to a bed partner of the patient to whom the questionnaire of FIG. 3 has been provided;
  • FIG. 5 is a flowchart depicting certain aspects of the improved method.
  • the word “unitary” means a component is created as a single piece or unit. That is, a component that includes pieces that are created separately and then coupled together as a unit is not a “unitary” component or body.
  • the statement that two or more parts or components “engage” one another shall mean that the parts exert a force against one another either directly or through one or more intermediate parts or components.
  • the term “number” shall mean one or an integer greater than one (i.e., a plurality).
  • Adherence to therapy is one of the biggest barriers to effective treatment of sleep disorders such as OSA and other sleep-related breathing disorders.
  • CPAP Continuous Positive Airway Pressure
  • the non-adherence rate has been estimated to be anywhere from 29% to 83%.
  • insomnia Another problem with sleep is insomnia, and the adherence rates to digital cognitive behavioral therapy for insomnia (i.e. e-CBTi) regimen can likewise be problematic. Adherence for other therapies for snoring treatment (e.g. mandibular advancement device for snoring) likewise can have limitations.
  • Apparatus 4 and method 100 use these insights to motivate patients with sleep disorders to seek diagnosis, start their therapy, and/or continue their therapy.
  • apparatus 4 and method 100 provide coaching for bed partners to offer suggestions to overcome negative spousal influence in various issues, such as interruptions to intimacy, concerns about image changes due to masks and appliances, and noise from Positive Airway Pressure (PAP) therapy devices and other therapy devices.
  • Apparatus 4 and method 100 thus enable both partners to work together towards shared positive benefits.
  • PAP treatment for OSA is an exemplary embodiment and other treatment regimen for other sleep disorders are also contemplated by the inventors.
  • a bed partner such as may include a spouse, by way of example, is affected by the patient's sleep disorder, and the BP has a significant if not dominant influence for both the seeking of sleep disorder treatment and the adherence to the treatment.
  • the “patient” may be referred to herein as a “bed partner”, and it is further noted that the “patient”, which is the bed partner with the primary sleep disorder, may not indeed be a “patient” at all, and may self-treat with OTC solutions.
  • each “bed partner” may themselves be a “patient” who has a primary sleep disorder that affects the sleep of the other bed partner.
  • a first bed partner may have OSA and RLS, and a second bed partner may be awakened by the first bed partner's OSA, but the second bed partner may also have OHS and Nocturia.
  • the treatment program needs to treat the first bed partner's OSA and the second bed partner's OHS and Nocturia.
  • the disclosed and claimed concept cover such bilateral primary sleep disorders, i.e., wherein each bed partner has a problem with sleep that is attributable to the other bed partner in addition to themselves having their own primary sleep disorder.
  • Primary sleep disorders would include sleep disordered breathing (Obstructive Sleep Apnea, Central Sleep Apnea, Cheyne-Stokes Respiration, Obesity Hypoventilation Syndrome), neurologic (Restless Leg Syndrome, Periodic Leg Movement Disorder, Insomnia, Pain), physiological disorders (Nocturia), and other disorders.
  • the solution can be said to have three phases: 1) Screening, which is to assess the likelihood of a sleep disorder for both bed partners, 2) Diagnostics, which is to diagnose the existence of Sleep Disorders that might be said to include OSA, Central Sleep Apnea (CSA), Cheyne-Stokes Respiration (CSR), and Obesity Hypoventilation Syndrome (OHS), and which also can include snoring, insomnia, chronic short sleep, restless legs syndrome, and delayed sleep phase disorder, by way of example and 3) Monitoring of therapy, which is to monitor adherence to a treatment plan and/or therapy and the efficacy of the treatment plan and/or therapy.
  • the system that implements this solution has a base configuration for each of the three phases.
  • Initial screening presents a questionnaire to both bed partners such as that found in FIG. 3 , or a simpler one based on responses to questions such as “Does your bed partner stop breathing for 15 seconds or more during the night?” The answers to the questions are processed and the result is analyzed to assess the probability of a sleep disorder for either or both of the BPs.
  • the exemplary questionnaire is only an OSA screener. Screening for other sleep disorders may alternatively or additionally be provided.
  • the screening continues to the assess the following:
  • the screening indicates sleep disordered breathing, then based on the answers to the screening questions, an appropriate diagnostic test is recommended or is provided.
  • HST Home Sleep Test
  • the dropout rate during the diagnostic phase potentially may be on the order of 50%.
  • the patient either may not take the sleep test, or the patient may drop out after taking the sleep test.
  • BP support is essential to keeping the patient engaged in the process.
  • a coaching and support method is disclosed herein in which the bed partner answers a context sensitive questionnaire. Based at least in part upon the answers to the context sensitive questionnaire, the coaching and support method selects the coaching method that is administered to the supporting bed partner.
  • the patient also has a supporting and coaching method, and the results of the two coaching methods are further processed to maximize the likelihood of adherence. It is understood that the relationship between bed partners is complex and thus the coaching method needs both sides of the story to be relevant and effective.
  • CPAP CPAP
  • the titration night is included here as well.
  • the overall adherence issues are still present, but the coaching method will focus on patient comfort with the breathing interface and will also focus on any emotional aspects that may be present.
  • the supporting bed partners may also be facing emotional and some logistical stress during the titration phase, and the coaching method asks context-sensitive questions to help both BPs through the titration night.
  • the BPs return to their bedroom with the new sleep therapy equipment, such as a CPAP ventilator or a specialized ventilator for CSR or OHS.
  • the new sleep therapy equipment such as a CPAP ventilator or a specialized ventilator for CSR or OHS.
  • other therapies such as a positional, mandibular advancement, and nasal Expiratory Positive Airway Pressure (EPAP) may have been prescribed. Regardless, the previous bedroom routine is changed and likely perceived as disruptive.
  • EEPAP Expiratory Positive Airway Pressure
  • a goal of the monitoring phase is to gather data on the following areas:
  • Apparatus 4 is depicted in a schematic fashion in FIG. 1 .
  • Apparatus 4 can be characterized as including a processor apparatus 8 that can be said to include a processor 12 and a storage 16 that are connected with one another.
  • Storage 16 has stored therein a number of routines 20 that are in the form of a non-transitory storage medium and that include instructions which, when executed on processor 12 , cause apparatus 4 to perform certain operations such as are mentioned elsewhere herein.
  • Apparatus 4 can be said to further include an input apparatus 24 that provides input signals to processor 12 and an output apparatus 28 that receives output signals from processor 12 .
  • Input apparatus 24 can be said to include any of a variety of input components, and output apparatus 28 can likewise be said to include any of a variety of output components.
  • output apparatus 28 might be said to include a visual display of the touchscreen, and input apparatus 24 might be said to include a touch-sensitive overlay that is situated atop the visual display.
  • apparatus 4 includes a wireless transceiver
  • input apparatus 24 might be said to include a receiver component of the wireless transceiver
  • output apparatus 28 might be said to include a transmitter component of the wireless transceiver.
  • Apparatus 4 can be any of a wide variety of devices and might include, for instance, a wearable device such as a smart watch or might include a cellular telephone. In certain embodiments of the disclosed and claimed concept, apparatus 4 might be said to include both a wearable device and a cellular telephone that are in wireless communication with one another and with other devices, and it thus can be seen that the depiction of apparatus 4 in FIG. 1 is intended to be schematic in nature, and is understood that the overall apparatus 4 can include any one or more of a wide variety of electronic devices.
  • Apparatus 4 is depicted in FIG. 1 as being in wireless communication via a first wireless link 30 with an enterprise data system 32 that itself includes a number of routines 36 that are executable on a processor of enterprise data system 32 in order to cause enterprise data system 32 to perform certain operations.
  • Apparatus 4 is further depicted in FIG. 1 as being wirelessly in communication with a therapy device 40 via a second wireless link 44 .
  • FIG. 1 is intended to schematically depicts a data processing, therapy-providing, coaching, and support system that includes any one or more of a wide variety of components that communicate with other components in order to provide respiratory therapy and to achieve the therapy goals that are noted herein.
  • numerous different types of devices can be in communication with other devices in order to perform the operations that are mentioned herein and that meet the goals that are described herein.
  • the data collection method includes questionnaires and on-demand subjective input, a data interface to therapy device 40 , and wearable devices.
  • Input apparatus 28 may include environmental sensors such as light and sound, and further may include active sensing such as RADAR and ultrasound measurement of body motion, respiration and heart rate, by way of example.
  • FIG. 2 describes a sensing and coaching system for both bed partners.
  • Bed partner 48 and bed partner 52 will receive personalized questionnaires 56 and 60 based on the objective data (if present), the answers to the questionnaire from the other bed partner 48 and 52 , and the results of previous coaching.
  • On-demand input 58 and 62 is an optional and can from a list of inputs from a menu or free form text to input to Natural Language Processing. For example, “BP A is not accepting the screening results” or “BP B just woke me up at 2:33 am.”
  • Coaching AB 64 processes all inputs in context to each other and creates a coaching A plan 68 and a coaching B plan 72 . It also stores a history 76 of coaching plans and the results of those plans and then applies a learning tool to improve the coaching plans.
  • a clinician portal 80 allows for monitoring of the progress and manual intervention to the coaching plans and the learning tool.
  • the Screening phase employs a questionnaire for each BP 48 and 52 , as are shown in FIGS. 3 and 4 , respectively, at the numerals 56 and 60 .
  • Other questionnaires can be adapted and validated for BPs 48 and 52 .
  • questionnaire 60 may appear to have questions for BP 52 that are similar to the questions in questionnaire 56 for answering by BP 48 , the thresholds used to assess a sleep disorder could change based on clinical data.
  • Android Sleep Analyzer has both passive listening and an active ultrasound method for measuring body motion and breathing. Occurrences of apneas and hypopneas are detected from the signals. Under mattress sensor such as the Withings Sleep—Sleep Tracking Pad also provides both the data and analysis to detect sleep disordered breathing.
  • One aspect of the disclosed and claimed concept is to assess the effect of the sleep disorders of the bed partners on their sleep.
  • An indication of the state of sleep (such as based upon activity, heart rate, and/or respiratory rate, for example) of one BP is measured concurrently with that of the other BP, and the sleep disruptions are compared to estimate the cause and effect relationship.
  • BP 48 snores lightly while in the lateral position (lying on side) and then rolls over to the supine position and snores loudly.
  • BP 52 sleep is not disrupted by light snoring but is completely disrupted by the loud snoring when BP 48 is in the supine position. From the aforementioned Pankhurst, F. P., Home, J.
  • a digital analysis of this approach helps in understanding the correlations between the micro and macro sleep structures (hypnograms) of BPs 48 and 52 , along with mapping out the time relationships between the sleep events of BPs 48 and 52 .
  • Such correlations between two sleep hypnograms are conveyed, such as through the use of timeline visualizations of sleep events, such as arousals, apnea events etc., with flagged sleep events from each bed partner.
  • An algorithmic metric for this step could be said to involve computing a sleep dependency “score” to give an overview of how the sleep of BPs 48 and 52 is inter-related.
  • mathematical tools like normalized cross-correlation of time-series can help determine causality.
  • a high amount of correlation with a time lag of, for example, between half a second and ten seconds (0.5 s ⁇ t ⁇ 10 s) is strongly indicative of causality one-direction (i.e. BP 48 is affecting the sleep quality of BP 52 ).
  • a high amount of correlation with a time lag of between negative half a second and negative 10 seconds is indicative of causality in the other direction (BP 52 is affected by the sleep of BP 48 ).
  • bed partner sleep disruption is often bidirectional, each bed partner 48 and 52 can be given a weighted score for the amount of sleep disruption he/she caused the other.
  • the sleep disruption scores can weighted by a sleep quality score for each bed partner 48 and 52 . Sleep scores are generated based at least in part upon measures that may include total sleep time (TST), sleep efficiency (SE %), total number of arousals, total time in deep sleep, total time in REM sleep, and other indicators of the quality of sleep.
  • the digital analysis step can be augmented using machine learning methods to detect correlations between BPs' sleep structures. This can also be used generate sleep response profiles of BPs.
  • the profiles consist of models built using time-stamped data along with sleep events. By running predictive models on these profiles over a sliding time-window, we predict sleep events of one BP that is likely to disrupt other's sleep. These predictions can be used to suggest pre-emptive interventions as well.
  • the profiles would be continuously updated as the users make use of the system and more data is available to improve accuracy.
  • these models can be visualized and presented to the BPs to help them proactively identify, diagnose, and take corrective measures for addressing co-dependent sleep issues.
  • a sleep tracker can also determine a set of time series signals for each bed partner in the exemplary form of a stimulus signal and a response signal.
  • the stimulus signal is comprised of actions by this bed partner that might cause a disturbance in the bedroom (e.g. snoring, gasping, movement, etc.).
  • the response signal is comprised of indications of having been potentially disturbed (e.g. sleep stage lightening, heart rate acceleration, autonomic arousal, awakening, extended period of awakening, etc.). It should be noted that the stimulus and response signals can be either binary or can have an amplitude assigned to them.
  • the assessment of the level of BP support is advantageously employed in selecting the coaching methods for each BP.
  • Objective data from any of the sensors listed elsewhere herein provides a grounding on what is actually happening during sleep, but the questionnaires and the given answers provide insights on the perceptions and relationship dynamics of BPs 48 and 52 . For example, if the patient states that no one has told him that he stops breathing at night, and the other BP answers that the patient does stop breathing, then the coaching for the patient would focus on “here's the data showing that you stopped breathing twenty times last night” and coaching for the BP would guide on how to best support the patient. Further, this system would also help partners with SDB understand how their conditions are affecting their partner's sleep, thereby motivating them to seek therapy and adhere to it. If the coaching AB method 64 detects an underlying conflict, and if the objective data indicates either or both BP have a SDB issue, the focus of the coaching to each will emphasize conflict resolution in order to improve the likelihood of adherence during the screening, diagnosis and monitoring phases.
  • any reference signs placed between parentheses shall not be construed as limiting the claim.
  • the word “comprising” or “including” does not exclude the presence of elements or steps other than those listed in a claim.
  • several of these means may be embodied by one and the same item of hardware.
  • the word “a” or “an” preceding an element does not exclude the presence of a plurality of such elements.
  • any device claim enumerating several means several of these means may be embodied by one and the same item of hardware.
  • the mere fact that certain elements are recited in mutually different dependent claims does not indicate that these elements cannot be used in combination.

Abstract

A system includes facilitating therapy with couples working together for perceiving shared positive benefits by treating sleep disordered breathing issues. Spousal influence can greatly influence and motivate the patient in continuing the therapy. Moreover, through monitoring bed partners' sleep using wearable data, causal information about whose sleep is affecting whom can be inferred. Users can be prompted to seek diagnosis and treatment for sleep disordered breathing conditions and can be used to help coach around therapy adherence.

Description

    CROSS-REFERENCE TO PRIOR APPLICATION
  • This application claims the benefit of U.S. Provisional Patent Application No. 62/990,110, filed Mar. 16, 2020 which is incorporated by reference herein.
  • BACKGROUND OF THE INVENTION 1. Field of the Invention
  • The present invention pertains to a sleep disorder treatment program, and, in particular, to a system and method for a bed partner mediated sleep disorder treatment program.
  • 2. Description of the Related Art
  • Numerous types of sleep disorders, including insomnia, restless legs syndrome, and sleep disordered breathing disorders, such as obstructive sleep apnea (OSA), central sleep apnea (CSA), and other such disorders, are known to exist. Likewise, numerous different types of therapy treatment are provided in order to treat such sleep disorders and sleep disordered breathing disorders.
  • Poor therapy adherence remains one of the biggest barriers to effective treatment for sleep disorders and sleep disordered breathing disorders. Spouses and domestic partners can play an important role in not only seeking, for instance, an OSA diagnosis, but also in adhering to therapy. Prior studies report that a patient's snoring often leads to multiple adverse effects to the bed partner including sleep disorders, such as insomnia, along with an effect on overall marital satisfaction.
  • Improvements in the way in which treatment is provided for sleep disorders and sleep disordered breathing disorders thus would be desirable.
  • SUMMARY OF THE INVENTION
  • Accordingly, it is an object of the present invention to provide an improved system and method for bed partner mediated sleep disorder treatment program that overcomes the shortcomings of conventional systems and methods for providing sleep disorder treatment programs. This object is achieved according to one embodiment of the present invention by providing a system that includes facilitating therapy with couples working together for perceiving shared positive benefits by treating sleep disorders and/or sleep disordered breathing issues. Spousal influence can greatly influence and motivate the patient in continuing the therapy. Moreover, through monitoring bed partners' sleep using wearable or other data, causal information about whose sleep is affecting whom can be inferred. It is noted that many objective and subjective sources of data/information could be used in order to derive the presence and causality of sleep disorders. Specific examples include under-mattress sensors, in-room audio sensors, app-based sensing (e.g. audio, sonar, or accelerometer-based), or subjective questionnaires or assessments. Users can be prompted to seek diagnosis and treatment for sleep disorder and/or sleep disordered breathing conditions and can be used to help coach around therapy adherence.
  • Accordingly, aspects of the disclosed and claimed concept are provided by an improved method of providing therapy to a first bed partner who sleeps with a second bed partner, the general nature of which can be stated as including determining that the first bed partner has a sleep disorder, determining that the second bed partner has a problem with sleep that is at least partially attributable to the sleep disorder of the first bed partner, and at least one of recommending and providing a treatment program or therapy to the first bed partner.
  • Other aspects of the disclosed and claimed concept are provided by an improved apparatus structured to indicate a need for therapy in a first bed partner who sleeps with a second bed partner, the general nature of which can be stated as including a processor apparatus comprising a processor and a storage, an input apparatus structured to provide input signals to the processor apparatus, an output apparatus structured to receive output signals from the processor apparatus, and the storage having stored therein a number of instructions which, when executed on the processor, cause the apparatus to perform a number of operations, the general nature of which can be stated as including determining that the first bed partner has a sleep disorder, determining that the second bed partner has a problem with sleep that is at least partially attributable to the sleep disorder of the first bed partner, and at least one of recommending and providing a treatment program and/or therapy to the first bed partner.
  • These and other objects, features, and characteristics of the present invention, as well as the methods of operation and functions of the related elements of structure and the combination of parts and economies of manufacture, will become more apparent upon consideration of the following description and the appended claims with reference to the accompanying drawings, all of which form a part of this specification, wherein like reference numerals designate corresponding parts in the various figures. It is to be expressly understood, however, that the drawings are for the purpose of illustration and description only and are not intended as a definition of the limits of the invention.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • FIG. 1 is a schematic depiction of an improved apparatus in accordance with an embodiment of the disclosed and claimed concept;
  • FIG. 2 is a schematic depiction of a process flow of an improved method in accordance with an embodiment of the disclosed and claimed concept;
  • FIG. 3 is an exemplary questionnaire that can be provided to a patient who may have a need for breathing therapy;
  • FIG. 4 is an exemplary questionnaire that can be provided to a bed partner of the patient to whom the questionnaire of FIG. 3 has been provided; and
  • FIG. 5 is a flowchart depicting certain aspects of the improved method.
  • Similar numerals refer to similar parts throughout the Specification.
  • DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS
  • As used herein, the singular form of “a”, “an”, and “the” include plural references unless the context clearly dictates otherwise. As used herein, the statement that two or more parts or components are “coupled” shall mean that the parts are joined or operate together either directly or indirectly, i.e., through one or more intermediate parts or components, so long as a link occurs. As used herein, “directly coupled” means that two elements are directly in contact with each other. As used herein, “fixedly coupled” or “fixed” means that two components are coupled so as to move as one while maintaining a constant orientation relative to each other.
  • As used herein, the word “unitary” means a component is created as a single piece or unit. That is, a component that includes pieces that are created separately and then coupled together as a unit is not a “unitary” component or body. As employed herein, the statement that two or more parts or components “engage” one another shall mean that the parts exert a force against one another either directly or through one or more intermediate parts or components. As employed herein, the term “number” shall mean one or an integer greater than one (i.e., a plurality).
  • Directional phrases used herein, such as, for example and without limitation, top, bottom, left, right, upper, lower, front, back, and derivatives thereof, relate to the orientation of the elements shown in the drawings and are not limiting upon the claims unless expressly recited therein.
  • Adherence to therapy is one of the biggest barriers to effective treatment of sleep disorders such as OSA and other sleep-related breathing disorders. For example, in the context of Continuous Positive Airway Pressure (CPAP) therapy, the non-adherence rate has been estimated to be anywhere from 29% to 83%. Ye, L., Malhotra, A., Kayser, K., Willis, D. G., Horowitz, J., Aloia, M., & Weaver, T. E. (2015); Spousal involvement and CPAP adherence: A dyadic perspective; Sleep Medicine Reviews, 19C: 67-74; https://doi.org/10.1016/j.smrv.2014.04.005. Another problem with sleep is insomnia, and the adherence rates to digital cognitive behavioral therapy for insomnia (i.e. e-CBTi) regimen can likewise be problematic. Adherence for other therapies for snoring treatment (e.g. mandibular advancement device for snoring) likewise can have limitations.
  • Spouses and domestic partners play an important role not only in seeking sleep-related breathing disorder diagnosis but also in adhering to therapy. Ye, L., Antonelli, M. T., Willis, D. G., Kayser, K., Malhotra, A, & Patel, S. R. (2017); Couple's Experiences with CPAP Therapy: A Dyadic Perspective; Sleep Health—Journal of the National Sleep Foundation, 3(5): 362-367; https://doi.org/10.1016/j.sleh.2017.07.003. Studies report that a patient's snoring can lead to multiple adverse effects to a patient's bed partner including sleep disorders, such as insomnia, along with a deleterious effect on overall marital and relationship satisfaction. Ulfberg, J., Carter, N., Talback, M., & Edling, C. (2000); Adverse health effects among women living with heavy snorers; Health Care for Women International, 21(2), 81-90.
  • Existing devices provide individual specific sleep insights, though sleep related disorders have an effect on patients along with their bed partners. Moreover, research points out that individuals often seem to be unaware of the correlations between sleep disturbances among bed partners. Pankhurst, F. P., Horne, J. A.; The influence of bed partners on movement during sleep; Sleep; 1994; 17(4):308-315; doi: 10.1093/sleep/17.4.308.
  • Described herein are an improved apparatus 4 and an improved method 100 for assessing sleep problems affecting patients and their bed partners (i.e., “How is one partner's sleep affect the other?”). Apparatus 4 and method 100 use these insights to motivate patients with sleep disorders to seek diagnosis, start their therapy, and/or continue their therapy. Similarly, apparatus 4 and method 100 provide coaching for bed partners to offer suggestions to overcome negative spousal influence in various issues, such as interruptions to intimacy, concerns about image changes due to masks and appliances, and noise from Positive Airway Pressure (PAP) therapy devices and other therapy devices. Apparatus 4 and method 100 thus enable both partners to work together towards shared positive benefits. It should be noted that PAP treatment for OSA is an exemplary embodiment and other treatment regimen for other sleep disorders are also contemplated by the inventors.
  • The disclosed and claimed concept is based on a new insight that a bed partner (BP), such as may include a spouse, by way of example, is affected by the patient's sleep disorder, and the BP has a significant if not dominant influence for both the seeking of sleep disorder treatment and the adherence to the treatment. It is noted that the “patient” may be referred to herein as a “bed partner”, and it is further noted that the “patient”, which is the bed partner with the primary sleep disorder, may not indeed be a “patient” at all, and may self-treat with OTC solutions. Furthermore, it is expressly noted that each “bed partner” may themselves be a “patient” who has a primary sleep disorder that affects the sleep of the other bed partner. For instance, a first bed partner may have OSA and RLS, and a second bed partner may be awakened by the first bed partner's OSA, but the second bed partner may also have OHS and Nocturia. In such an exemplary situation, the treatment program needs to treat the first bed partner's OSA and the second bed partner's OHS and Nocturia. The disclosed and claimed concept cover such bilateral primary sleep disorders, i.e., wherein each bed partner has a problem with sleep that is attributable to the other bed partner in addition to themselves having their own primary sleep disorder. Primary sleep disorders would include sleep disordered breathing (Obstructive Sleep Apnea, Central Sleep Apnea, Cheyne-Stokes Respiration, Obesity Hypoventilation Syndrome), neurologic (Restless Leg Syndrome, Periodic Leg Movement Disorder, Insomnia, Pain), physiological disorders (Nocturia), and other disorders.
  • The solution can be said to have three phases: 1) Screening, which is to assess the likelihood of a sleep disorder for both bed partners, 2) Diagnostics, which is to diagnose the existence of Sleep Disorders that might be said to include OSA, Central Sleep Apnea (CSA), Cheyne-Stokes Respiration (CSR), and Obesity Hypoventilation Syndrome (OHS), and which also can include snoring, insomnia, chronic short sleep, restless legs syndrome, and delayed sleep phase disorder, by way of example and 3) Monitoring of therapy, which is to monitor adherence to a treatment plan and/or therapy and the efficacy of the treatment plan and/or therapy. The system that implements this solution has a base configuration for each of the three phases.
  • Screening: Initial screening presents a questionnaire to both bed partners such as that found in FIG. 3, or a simpler one based on responses to questions such as “Does your bed partner stop breathing for 15 seconds or more during the night?” The answers to the questions are processed and the result is analyzed to assess the probability of a sleep disorder for either or both of the BPs. There are a number of other tools that can be used to collect objective screening data that could help, such as wearables, scales, under-mattress sensors, etc. It is further noted that the exemplary questionnaire is only an OSA screener. Screening for other sleep disorders may alternatively or additionally be provided.
  • If the initial screening indicates a sufficient probability of a sleep disorder, then the screening continues to the assess the following:
      • Effect of the Sleep Disorder on each of the BPs;
      • Probability of adherence to therapy; and
      • Level of support that is expected to be provided by each bed partner to the other during the diagnostic and therapy journey.
  • If the screening indicates sleep disordered breathing, then based on the answers to the screening questions, an appropriate diagnostic test is recommended or is provided.
  • Diagnostics: A series of follow-up questions to the screening phase are administered to select the best path forward for diagnostics. For example, if the BPs are tech savvy then a self-administered Home Sleep Test (HST) might be preferred, rather than spending a night in a sleep lab. It is noted that HST is key for SDB and RLS, but may not be necessary for other sleep disorders, including consumer-focused sleep disorders (e.g. snoring or trouble falling asleep). For a set of bed partners that would not be comfortable with the setting up an HST, then an option is to have a technician set up the HST in the home or in the office, or to conduct the testing in a sleep lab.
  • The dropout rate during the diagnostic phase potentially may be on the order of 50%. The patient either may not take the sleep test, or the patient may drop out after taking the sleep test. BP support is essential to keeping the patient engaged in the process. A coaching and support method is disclosed herein in which the bed partner answers a context sensitive questionnaire. Based at least in part upon the answers to the context sensitive questionnaire, the coaching and support method selects the coaching method that is administered to the supporting bed partner. The patient also has a supporting and coaching method, and the results of the two coaching methods are further processed to maximize the likelihood of adherence. It is understood that the relationship between bed partners is complex and thus the coaching method needs both sides of the story to be relevant and effective.
  • If CPAP is prescribed, then the titration night is included here as well. The overall adherence issues are still present, but the coaching method will focus on patient comfort with the breathing interface and will also focus on any emotional aspects that may be present. The supporting bed partners may also be facing emotional and some logistical stress during the titration phase, and the coaching method asks context-sensitive questions to help both BPs through the titration night.
  • Monitoring: After the titration night, the BPs return to their bedroom with the new sleep therapy equipment, such as a CPAP ventilator or a specialized ventilator for CSR or OHS. Alternatively, other therapies such a positional, mandibular advancement, and nasal Expiratory Positive Airway Pressure (EPAP) may have been prescribed. Regardless, the previous bedroom routine is changed and likely perceived as disruptive.
  • A goal of the monitoring phase is to gather data on the following areas:
      • Therapy efficacy;
      • Adherence to Therapy;
      • Sleep Hygiene;
      • Individual BP's sleep quality; and
      • Correlation of one BP's sleep habits to the other BP's sleep quality.
        Data from above will drive the individualized coaching methods delivered to both bed partners.
  • Apparatus 4 is depicted in a schematic fashion in FIG. 1. Apparatus 4 can be characterized as including a processor apparatus 8 that can be said to include a processor 12 and a storage 16 that are connected with one another. Storage 16 has stored therein a number of routines 20 that are in the form of a non-transitory storage medium and that include instructions which, when executed on processor 12, cause apparatus 4 to perform certain operations such as are mentioned elsewhere herein.
  • Apparatus 4 can be said to further include an input apparatus 24 that provides input signals to processor 12 and an output apparatus 28 that receives output signals from processor 12. Input apparatus 24 can be said to include any of a variety of input components, and output apparatus 28 can likewise be said to include any of a variety of output components. For instance, if apparatus 4 includes a touchscreen, output apparatus 28 might be said to include a visual display of the touchscreen, and input apparatus 24 might be said to include a touch-sensitive overlay that is situated atop the visual display. Likewise, if apparatus 4 includes a wireless transceiver, input apparatus 24 might be said to include a receiver component of the wireless transceiver, and output apparatus 28 might be said to include a transmitter component of the wireless transceiver.
  • Apparatus 4 can be any of a wide variety of devices and might include, for instance, a wearable device such as a smart watch or might include a cellular telephone. In certain embodiments of the disclosed and claimed concept, apparatus 4 might be said to include both a wearable device and a cellular telephone that are in wireless communication with one another and with other devices, and it thus can be seen that the depiction of apparatus 4 in FIG. 1 is intended to be schematic in nature, and is understood that the overall apparatus 4 can include any one or more of a wide variety of electronic devices.
  • Apparatus 4 is depicted in FIG. 1 as being in wireless communication via a first wireless link 30 with an enterprise data system 32 that itself includes a number of routines 36 that are executable on a processor of enterprise data system 32 in order to cause enterprise data system 32 to perform certain operations. Apparatus 4 is further depicted in FIG. 1 as being wirelessly in communication with a therapy device 40 via a second wireless link 44. It thus can be understood that FIG. 1 is intended to schematically depicts a data processing, therapy-providing, coaching, and support system that includes any one or more of a wide variety of components that communicate with other components in order to provide respiratory therapy and to achieve the therapy goals that are noted herein. As such, it is expressly pointed out that numerous different types of devices can be in communication with other devices in order to perform the operations that are mentioned herein and that meet the goals that are described herein.
  • The data collection method includes questionnaires and on-demand subjective input, a data interface to therapy device 40, and wearable devices. Input apparatus 28 may include environmental sensors such as light and sound, and further may include active sensing such as RADAR and ultrasound measurement of body motion, respiration and heart rate, by way of example.
  • The system to implement the sensing and coaching methods is shown in FIG. 2, which describes a sensing and coaching system for both bed partners. Bed partner 48 and bed partner 52 will receive personalized questionnaires 56 and 60 based on the objective data (if present), the answers to the questionnaire from the other bed partner 48 and 52, and the results of previous coaching. On- demand input 58 and 62 is an optional and can from a list of inputs from a menu or free form text to input to Natural Language Processing. For example, “BP A is not accepting the screening results” or “BP B just woke me up at 2:33 am.” Coaching AB 64 processes all inputs in context to each other and creates a coaching A plan 68 and a coaching B plan 72. It also stores a history 76 of coaching plans and the results of those plans and then applies a learning tool to improve the coaching plans. A clinician portal 80 allows for monitoring of the progress and manual intervention to the coaching plans and the learning tool.
  • The Screening phase employs a questionnaire for each BP 48 and 52, as are shown in FIGS. 3 and 4, respectively, at the numerals 56 and 60. Other questionnaires can be adapted and validated for BPs 48 and 52. Although questionnaire 60 may appear to have questions for BP 52 that are similar to the questions in questionnaire 56 for answering by BP 48, the thresholds used to assess a sleep disorder could change based on clinical data.
  • Supplementing the questionnaire data with additional information such as that from passive and active sleep analyzers is also provided. As examples, Android Sleep Analyzer has both passive listening and an active ultrasound method for measuring body motion and breathing. Occurrences of apneas and hypopneas are detected from the signals. Under mattress sensor such as the Withings Sleep—Sleep Tracking Pad also provides both the data and analysis to detect sleep disordered breathing.
  • One aspect of the disclosed and claimed concept is to assess the effect of the sleep disorders of the bed partners on their sleep. An indication of the state of sleep (such as based upon activity, heart rate, and/or respiratory rate, for example) of one BP is measured concurrently with that of the other BP, and the sleep disruptions are compared to estimate the cause and effect relationship. For example, BP 48 snores lightly while in the lateral position (lying on side) and then rolls over to the supine position and snores loudly. BP 52 sleep is not disrupted by light snoring but is completely disrupted by the loud snoring when BP 48 is in the supine position. From the aforementioned Pankhurst, F. P., Home, J. A.; The influence of bed partners on movement during sleep; Sleep; 1994; 17(4):308-315; doi: 10.1093/sleep/17.4.308., the sleep hypnogram can show this cause and effect, and although BP 48 may not have any recollection of the snoring, the data will show that it did happen, and that BP 52 was adversely affected.
  • A digital analysis of this approach helps in understanding the correlations between the micro and macro sleep structures (hypnograms) of BPs 48 and 52, along with mapping out the time relationships between the sleep events of BPs 48 and 52. Such correlations between two sleep hypnograms are conveyed, such as through the use of timeline visualizations of sleep events, such as arousals, apnea events etc., with flagged sleep events from each bed partner. An algorithmic metric for this step could be said to involve computing a sleep dependency “score” to give an overview of how the sleep of BPs 48 and 52 is inter-related. Specifically, mathematical tools like normalized cross-correlation of time-series can help determine causality. A high amount of correlation with a time lag of, for example, between half a second and ten seconds (0.5 s<t<10 s) is strongly indicative of causality one-direction (i.e. BP 48 is affecting the sleep quality of BP 52). Alternatively, a high amount of correlation with a time lag of between negative half a second and negative 10 seconds (−0.5>t>−10 s) is indicative of causality in the other direction (BP 52 is affected by the sleep of BP 48). As bed partner sleep disruption is often bidirectional, each bed partner 48 and 52 can be given a weighted score for the amount of sleep disruption he/she caused the other. The sleep disruption scores can weighted by a sleep quality score for each bed partner 48 and 52. Sleep scores are generated based at least in part upon measures that may include total sleep time (TST), sleep efficiency (SE %), total number of arousals, total time in deep sleep, total time in REM sleep, and other indicators of the quality of sleep.
  • The digital analysis step can be augmented using machine learning methods to detect correlations between BPs' sleep structures. This can also be used generate sleep response profiles of BPs. The profiles consist of models built using time-stamped data along with sleep events. By running predictive models on these profiles over a sliding time-window, we predict sleep events of one BP that is likely to disrupt other's sleep. These predictions can be used to suggest pre-emptive interventions as well. The profiles would be continuously updated as the users make use of the system and more data is available to improve accuracy.
  • Apart from automated intervention suggestions, these models can be visualized and presented to the BPs to help them proactively identify, diagnose, and take corrective measures for addressing co-dependent sleep issues.
  • A sleep tracker can also determine a set of time series signals for each bed partner in the exemplary form of a stimulus signal and a response signal. The stimulus signal is comprised of actions by this bed partner that might cause a disturbance in the bedroom (e.g. snoring, gasping, movement, etc.). The response signal is comprised of indications of having been potentially disturbed (e.g. sleep stage lightening, heart rate acceleration, autonomic arousal, awakening, extended period of awakening, etc.). It should be noted that the stimulus and response signals can be either binary or can have an amplitude assigned to them. Once the stimulus and response signals are defined, the number of response events that were preceded by a BP's stimulus signal (e.g. within 0.5-10 s preceding) are counted. Then, an index of the number of arousal events generated by the bed partner are calculated (e.g. number of events per hour of sleep).
  • The assessment of the level of BP support is advantageously employed in selecting the coaching methods for each BP. Objective data from any of the sensors listed elsewhere herein provides a grounding on what is actually happening during sleep, but the questionnaires and the given answers provide insights on the perceptions and relationship dynamics of BPs 48 and 52. For example, if the patient states that no one has told him that he stops breathing at night, and the other BP answers that the patient does stop breathing, then the coaching for the patient would focus on “here's the data showing that you stopped breathing twenty times last night” and coaching for the BP would guide on how to best support the patient. Further, this system would also help partners with SDB understand how their conditions are affecting their partner's sleep, thereby motivating them to seek therapy and adhere to it. If the coaching AB method 64 detects an underlying conflict, and if the objective data indicates either or both BP have a SDB issue, the focus of the coaching to each will emphasize conflict resolution in order to improve the likelihood of adherence during the screening, diagnosis and monitoring phases.
  • In the claims, any reference signs placed between parentheses shall not be construed as limiting the claim. The word “comprising” or “including” does not exclude the presence of elements or steps other than those listed in a claim. In a device claim enumerating several means, several of these means may be embodied by one and the same item of hardware. The word “a” or “an” preceding an element does not exclude the presence of a plurality of such elements. In any device claim enumerating several means, several of these means may be embodied by one and the same item of hardware. The mere fact that certain elements are recited in mutually different dependent claims does not indicate that these elements cannot be used in combination.
  • Although the invention has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments, it is to be understood that such detail is solely for that purpose and that the invention is not limited to the disclosed embodiments, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present invention contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.

Claims (20)

What is claimed is:
1. A method (100) of providing a treatment program in a situation in which a first bed partner (48) who sleeps with a second bed partner (52), comprising:
determining (120) that the first bed partner has a sleep disorder;
determining (130) that the second bed partner has a problem with sleep that is attributable to the sleep disorder of the first bed partner; and
at least one of recommending and providing a treatment program (140) to at least one of the first bed partner and second bed partner.
2. The method of claim 1 wherein the determining that the first bed partner has a sleep disorder comprises assessing at least one first state of sleep of the first bed partner, and wherein the determining that the second bed partner has a sleep disorder that is attributable to the sleep disorder of the first bed partner comprises assessing at least one second state of sleep of the second bed partner.
3. The method of claim 2 wherein the assessing of the at least one first state of sleep comprises assessing at least one of an activity, a heart rate, and a respiratory rate of the first bed partner, and wherein the assessing of the at least one second state of sleep comprises assessing at least one of an activity, a heart rate, a respiratory rate, along with subjective questionnaires for the second bed partner.
4. The method of claim 3 wherein the determining that the second bed partner has a sleep disorder that is attributable to the sleep disorder of the first bed partner further comprises identifying a correlation between the at least one first state of sleep and the at least one second state of sleep.
5. The method of claim 4 wherein the assessing of the at least one first state of sleep further comprises identifying at least one first sleep event of the first sleep partner, and wherein the assessing of the at least one second state of sleep further comprises identifying at least one second sleep event of the second sleep partner.
6. The method of claim 5 wherein the identifying of the correlation comprises determining that the at least one first sleep event occurred within a predetermined period of time of the at least one second sleep event.
7. The method of claim 5 wherein the identifying of the correlation comprises determining a sleep dependency score that is representative of an extent to which the at least one first state of sleep and the at least one second state of sleep are correlated.
8. The method of claim 7, further comprising:
determining a first weighted sleep dependency score for the first bed partner by applying a first sleep quality score for the first bed partner to the sleep dependency score;
determining the first sleep quality score based at least in part upon at least one of a total sleep time, a sleep efficiency, a total number of arousals, a total time in deep sleep, and a total time in Rapid Eye Movement (REM) sleep of the first bed partner;
determining a second weighted sleep dependency score for the second bed partner by applying a second sleep quality score for the second bed partner to the sleep dependency score; and
determining the second sleep quality score based at least in part upon at least one of a total sleep time, a sleep efficiency, a total number of arousals, a total time in deep sleep, and a total time in Rapid Eye Movement (REM) sleep of the second bed partner.
9. The method of claim 1, further comprising:
providing a first questionnaire to the first bed partner;
receiving a number of first answers from the first bed partner responsive to the first questionnaire;
providing a second questionnaire to the second bed partner;
receiving a number of second answers from the second bed partner responsive to the second questionnaire; and
outputting a coaching plan for at least one of the first bed partner and the second bed partner based at least in part upon at least one of the number of first answers and the number of second answers.
10. The method of claim 9, further comprising outputting another coaching plan for at least one of the first bed partner and the second bed partner that is based at least in part upon the coaching plan.
11. An apparatus (4) structured to provide a treatment program in a situation in which a first bed partner (48) who sleeps with a second bed partner (52), comprising:
a processor apparatus (8) comprising a processor (12) and a storage (16);
an input apparatus (24) structured to provide input signals to the processor apparatus;
an output apparatus (28) structured to receive output signals from the processor apparatus;
the storage having stored therein a number of instructions (20) which, when executed on the processor, cause the apparatus to perform a number of operations comprising:
determining (120) that the first bed partner has a sleep disorder;
determining (130) that the second bed partner has a problem with sleep that is attributable to the sleep disorder of the first bed partner; and
at least one of recommending and providing a treatment program (140) to at least one of the first bed partner and second bed partner.
12. The apparatus of claim 11 wherein the determining that the first bed partner has a sleep disorder comprises assessing at least one first state of sleep of the first bed partner, and wherein the determining that the second bed partner has a sleep disorder that is attributable to the sleep disorder of the first bed partner comprises assessing at least one second state of sleep of the second bed partner.
13. The apparatus of claim 12 wherein the assessing of the at least one first state of sleep comprises assessing at least one of an activity, a heart rate, and a respiratory rate of the first bed partner, and wherein the assessing of the at least one second state of sleep comprises assessing at least one of an activity, a heart rate, and a respiratory rate of the second bed partner.
14. The apparatus of claim 13 wherein the determining that the second bed partner has a sleep disorder that is attributable to the sleep disorder of the first bed partner further comprises identifying a correlation between the at least one first state of sleep and the at least one second state of sleep.
15. The apparatus of claim 14 wherein the assessing of the at least one first state of sleep further comprises identifying at least one first sleep event of the first sleep partner, and wherein the assessing of the at least one second state of sleep further comprises identifying at least one second sleep event of the second sleep partner.
16. The apparatus of claim 15 wherein the identifying of the correlation comprises determining that the at least one first sleep event occurred within a predetermined period of time of the at least one second sleep event.
17. The apparatus of claim 15 wherein the identifying of the correlation comprises determining a sleep dependency score that is representative of an extent to which the at least one first state of sleep and the at least one second state of sleep are correlated.
18. The apparatus of claim 17 wherein the operations further comprise:
determining a first weighted sleep dependency score for the first bed partner by applying a first sleep quality score for the first bed partner to the sleep dependency score;
determining the first sleep quality score based at least in part upon at least one of a total sleep time, a sleep efficiency, a total number of arousals, a total time in deep sleep, and a total time in Rapid Eye Movement (REM) sleep of the first bed partner;
determining a second weighted sleep dependency score for the second bed partner by applying a second sleep quality score for the second bed partner to the sleep dependency score; and
determining the second sleep quality score based at least in part upon at least one of a total sleep time, a sleep efficiency, a total number of arousals, a total time in deep sleep, and a total time in Rapid Eye Movement (REM) sleep of the second bed partner.
19. The apparatus of claim 11 wherein the operations further comprise:
providing a first questionnaire to the first bed partner;
receiving a number of first answers from the first bed partner responsive to the first questionnaire;
providing a second questionnaire to the second bed partner;
receiving a number of second answers from the second bed partner responsive to the second questionnaire; and
outputting a coaching plan for at least one of the first bed partner and the second bed partner based at least in part upon at least one of the number of first answers and the number of second answers.
20. The apparatus of claim 19 wherein the operations further comprise outputting another coaching plan for at least one of the first bed partner and the second bed partner that is based at least in part upon the coaching plan.
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