# US 12,109,364 B2 · Devices and systems for promoting continuous sleep of a subject and methods of using same > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,109,364 B2 - Document ID: US12109364B2 - Status: Granted - Kind: B2 - Application number: 17/160,821 - Filed: 2021-01-28 - Published: 2021-05-20 - Granted: 2024-10-08 - Earliest claimed: 2019-04-01 - Assignees: Duke University - Applicants: Duke University - Inventors: Sujay M. Kansagra - Web page: https://patentgrep.com/patent/US12109364B2 ## CPC - A61M 21/02: for inducing sleep or relaxation, e.g. by direct nerve stimulation, hypnosis, analgesia (for massage A61H; electrotherapy A61N, e.g. applying alternating or intermittent electric currents for producing anaesthesia A61N1/36021) - A61B 5/4809: {Sleep detection, i.e. determining whether a subject is asleep or not} - A61B 2503/04: Babies, e.g. for SIDS detection - A61M 2021/0022: {by the tactile sense, e.g. vibrations} - A61M 2021/0027: {by the hearing sense} - A61M 2021/0044: {by the sight sense} - A61M 2205/3327: Measuring - A61M 2205/3375: Acoustical, e.g. ultrasonic, measuring means - A61M 2205/3584: using modem, internet or Bluetooth® - A61M 2205/50: with microprocessors or computers - A61M 2205/502: User interfaces, e.g. screens or keyboards - A61M 2209/088: on the body - A61M 2240/00: Specially adapted for neonatal use - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract A method for promoting continuous sleep of a subject by eliminating and/or preventing sleep associations includes: (a) providing an apparatus including at least one sensor and at least one output device; (b) monitoring a state of the subject using the apparatus; (c) determining the subject is in an awake state using the at least one sensor; (d) in response to determining the subject is in the awake state, initiating and maintaining an output using the at least one output device; (e) determining the subject is in a sleep state using the at least one sensor; (f) halting the output in response to determining that the subject is in the sleep state such that the apparatus does not produce any output; (g) repeating at least step (b) during a sleep session. The method further includes modifying an intensity of the output over time until the intensity reaches zero. ## Claims ### Claim 1 A method for promoting continuous sleep of a subject by eliminating and/or preventing sleep associations, the method comprising: (a) providing an apparatus comprising at least one sensor and at least one output device; (b) monitoring a state of the subject using the apparatus; (c) determining the subject is in an awake state using the at least one sensor; (d) based on determining the subject is in the awake state, initiating and maintaining an output that is configured to be detected by the subject using the at least one output device, wherein the output comprises audio output; (e) determining the subject is in a sleep state using the at least one sensor; (f) halting the output including the audio output based on determining that the subject is in the sleep state in a manner that the apparatus does not produce any output while the subject is in the sleep state; (g) repeating at least step (b) during a sleep session, wherein the method further comprises modifying an intensity of the output over time until the intensity reaches zero to eliminate a sleep association, wherein the method is carried out over an entrainment phase and a subsequent sleep training phase, and wherein the step of modifying the intensity of the output over time is carried out during the sleep training phase, wherein the method further comprises, while in the entrainment phase: determining a total amount of time the subject is in the awake state per night; and switching from the entrainment phase to the sleep training phase based on determining that the total amount of time the subject is in the awake state is less than a predetermined amount of time on a particular night or on each night of a series of consecutive nights, wherein the method further comprises, in the sleep training phase: determining a total amount of time the subject is in the awake state per night; decreasing the intensity of the output based on determining that the total amount of time the subject is in the awake state is less than a predetermined amount of time on a particular night or on each night of a series of consecutive nights; and eliminating the sleep association based on sleep patterns of the subject by repeating the determining and decreasing steps until the intensity of the output is zero. ### Claim 2 (depends on 1) The method of claim 1, further comprising, in the sleep training phase: increasing the intensity of the output based on determining that the total amount of time the subject is in the awake state is greater than the predetermined amount of time on a particular night or on each night of a series of consecutive nights; and repeating the determining, decreasing, and increasing steps until the intensity of the output is zero. ### Claim 3 (depends on 1) The method of claim 1, further comprising increasing the intensity of the output based on determining that the subject is in the awake state for longer than a predetermined amount of time. ### Claim 4 (depends on 1) The method of claim 1, wherein the apparatus comprises a mattress, a mattress pad configured to be received under a mattress, a mattress pad configured to be received over a mattress, a crib, a device configured to attach to a crib, or a wearable device. ### Claim 5 (depends on 1) The method of claim 1, wherein the at least one sensor comprises a microphone and/or an accelerometer. ### Claim 6 (depends on 1) The method of claim 1, wherein the at least one output device comprises an actuator and/or a speaker. ### Claim 7 (depends on 1) The method of claim 1, wherein: initiating and maintaining the output is carried out after a predetermined amount of time after continuously determining the subject is in the awake state; and halting the output is carried out after a predetermined amount of time after continuously determining the subject is in the sleep state. ### Claim 8 (depends on 1) The method of claim 1, wherein: the at least one sensor and the at least one output device are each in communication with a processor, determining the subject is in the awake state and determining the subject is in the sleep state are carried out using the processor based on data captured by the at least one sensor, and initiating and maintaining the output and halting the output are carried out based on instructions generated by the processor. ### Claim 9 (depends on 8) The method of claim 8, wherein the apparatus comprises the processor. ### Claim 10 (depends on 8) The method of claim 8, wherein the apparatus comprises a communication device, and wherein a connected device in communication with the apparatus comprises the processor. ### Claim 11 (depends on 10) The method of claim 10, further comprising modifying the operation of the apparatus based on user input on the connected device. ### Claim 12 (depends on 1) The method of claim 1, further comprising: cycling through a plurality of different outputs; determining which particular output or combination of outputs are most effective for promoting continuous sleep for the subject; and using the particular output or combination of outputs that are most effective for promoting continuous sleep for the subject as the output. ### Claim 13 A system for promoting continuous sleep of a subject by eliminating and/or preventing sleep associations, the system comprising: an apparatus comprising at least one sensor and at least one output device; and a processor in communication with the at least one sensor and the at least one output device and, during an entrainment phase, configured to: (a) monitor a state of the subject; (b) determine the subject is in an awake state based on data received from the at least one sensor; (c) based on determining the subject is in the awake state, direct the at least one output device to initiate and maintain an output that is configured to be detected by the subject, wherein the output comprises audio output; (d) determine the subject is in a sleep state based on data received from the at least one sensor; (e) direct the at least one output device to halt the output including the audio output based on determining that the subject is in the sleep state in a manner that the apparatus does not produce any output while the subject is in the sleep state; and (f) repeat at least operation (a) during a sleep session, wherein, during a sleep training phase that is directly subsequent to the entrainment phase, the processor is configured to modify an intensity of the output over time until the intensity reaches zero to eliminate a sleep association, wherein the processor is configured to: determine a total amount of time the subject is in the awake state per night; and switch the apparatus from the entrainment phase to the sleep training phase based on determining that the total amount of time the subject is in the awake state is less than a predetermined amount of time on a particular night or on each night of a series of consecutive nights, wherein the processor is, during the sleep training phase, configured to eliminate the sleep association based on sleep patterns of the subject by repeatedly, until the intensity of the output is zero: determine a total amount of time the subject is in the awake state per night; and direct the at least one output device to decrease the intensity of the output based on the total amount of time the subject is in the awake state is less than a predetermined amount of time on a particular night or on each night of a series of consecutive nights. ### Claim 14 (depends on 13) The system of claim 13, wherein the processor is, during the sleep training phase, configured to direct the at least one output device to increase the intensity of the output based on the total amount of time the subject is in the awake state is greater than the predetermined amount of time on a particular night or on each night of a series of consecutive nights. ### Claim 15 (depends on 13) The system of claim 13, wherein the apparatus comprises a communication device, and wherein the system comprises a connected device in communication with the apparatus with the connected device comprising the processor. ### Claim 16 (depends on 13) The system of claim 13, wherein the system is configured to receive user input to: establish initial settings, select preferred sounds and motions for the output, adjust the predetermined amount of time of continuously determining the subject is in the awake state before the processor directs the at least one output device to initiate and maintain the output, adjust the intensity of the output in real time, select types of sounds of the output, adjust or select a nature of motion of the output, adjust or select a length of time for the entrainment phase, adjust or select a length of time for the sleep training phase, and/or adjust or select the rate of the decreasing the intensity of the output during the sleep training phase. ### Claim 17 An apparatus for promoting continuous sleep of a subject by eliminating and/or preventing sleep associations, the apparatus comprising: at least one sensor; at least one output device; and a processor in communication with the at least one sensor and the at least one output device and, during an entrainment phase, configured to repeatedly: determine the subject is in an awake state based on data received from the at least one sensor; based on determining the subject is in the awake state, direct the at least one output device to initiate and maintain an output that is configured to be detected by the subject, wherein the output comprises audio output; determine the subject is in a sleep state based on data received from the at least one sensor; and direct the at least one output device to halt the output including the audio output based on determining that the subject is in the sleep state in a manner that the apparatus does not produce any output while the subject is in the sleep state, wherein, during a sleep training phase that is directly subsequent to the entrainment phase, the processor is configured to modify an intensity of the output over time until the intensity reaches zero to eliminate a sleep association, wherein the processor is configured to: determine a total amount of time the subject is in the awake state per night; and switch the apparatus from the entrainment phase to the sleep training phase based on to determining that the total amount of time the subject is in the awake state is less than a predetermined amount of time on a particular night or on each night of a series of consecutive nights, wherein the processor is, during the sleep training phase, configured to eliminate the sleep association based on sleep patterns of the subject by repeatedly, until the intensity of the output is zero: determine a total amount of time the subject is in the awake state per night; and direct the at least one output device to decrease the intensity of the output based on the total amount of time the subject is in the awake state is less than a predetermined amount of time on a particular night or on each night of a series of consecutive nights. ### Claim 18 A method for promoting continuous sleep of a subject by eliminating and/or preventing sleep associations, the method comprising: (a) providing an apparatus comprising at least one sensor and at least one output device; (b) monitoring a state of the subject using the apparatus; (c) determining the subject is in an awake state using the at least one sensor; (d) based on determining the subject is in the awake state, initiating and maintaining an output that is configured to be detected by the subject using the at least one output device; (e) determining the subject is in a sleep state using the at least one sensor; (f) halting the output based on determining that the subject is in the sleep state in a manner that the apparatus does not produce any output while the subject is in the sleep state; (g) repeating at least step (b) during a sleep session, wherein the method further comprises modifying an intensity of the output over time until the intensity reaches zero to eliminate a sleep association, wherein the method is carried out over an entrainment phase and a subsequent sleep training phase, and wherein the step of modifying the intensity of the output over time is carried out during the sleep training phase, wherein the method further comprises, while in the entrainment phase: determining a total amount of time the subject is in the awake state per night; and switching from the entrainment phase to the sleep training phase based on determining that the total amount of time the subject is in the awake state is less than a predetermined amount of time on a particular night or on each night of a series of consecutive nights, wherein the method further comprises, in the sleep training phase: determining a total amount of time the subject is in the awake state per night; decreasing the intensity of the output based on determining that the total amount of time the subject is in the awake state is less than a predetermined amount of time on a particular night or on each night of a series of consecutive nights; and eliminating the sleep association based on sleep patterns of the subject by repeating the determining and decreasing steps until the intensity of the output is zero, wherein at least one of: (i) the entrainment phase has a duration of greater than zero days and 30 days or less; and (ii) the sleep training phase has a duration of greater than zero days and 30 days or less.