Patch system for monitoring and enhancing sleep and circadian rhythm alignment

Abstract

Disclosed are novel compositions, devices, patches, systems and methods that are useful for estimating, determining, modulating and/or improving the sleep/wake and/or circadian phase of a subject (e.g., a human subject) by the dispensing of measured quantities of agents to a subject or into an environment of the subject and the continuous monitoring and/or tracking of the subject's consciousness (e.g., sleep/wake) patterns. In certain aspects, the compositions, devices, patches, systems and methods disclosed herein are capable of delivering one or more agents to a subject in response to measured consciousness patterns estimations and circadian phase estimations, thereby aligning the subject's circadian biology to the external environment and improving the quality and duration of sleep.

1 - 47 . (canceled) 
     
     
         48 . A method for adjusting consciousness patterns and circadian states of one or more subjects, the method comprising:
 providing an olfactory dispensing unit;   actuating the olfactory dispensing unit using a control unit, and storing data from one or more sensors;   performing, using the one or more sensors, a function selected from the group consisting of estimating and tracking activity and inactivity data for one or more subjects, collecting and monitoring consciousness patterns data for one or more subjects, and quantifying measurements of circadian outcomes for one or more subjects;   inputting, using a user interface, control commands for using the control unit to actuate the olfactory dispensing unit to dispense the olfactory agents;   electronically communicating, between the olfactory dispensing unit and the control unit and between the user interface and control unit; and   dispensing of the olfactory agents, thereby modulating a circadian phase of the one or more subjects in response to a condition of the one or more subjects and an environment of the one or more subjects.   
     
     
         49 . The method of  claim 48 , wherein the one or more sensors are configured to collect and monitor consciousness patterns data of the one or more subjects;
 wherein the consciousness patterns comprise the subjects' sleep/wake patterns;   wherein the monitoring consciousness patterns data comprises using the one or more sensors to quantify the sleep and circadian system of the one or more subjects by sensing at least one signal selected from the group consisting of rest and activity cycles using actigraphy, signals using polysomnography, skin temperature, sleep onset time and duration, environmental light exposure, total light dosage received by the one or more subjects over a period of time, pulse oximetry, blood oxygen saturation levels, sweat and other skin secretions of the one or more subjects, and biofeedback signals indicative of sleep patterns of the one or more subjects; and   wherein the control unit uses consciousness patterns data of each of the one more subjects to optimize a formulation of the olfactory agents in real-time to provide cues to achieve a stimuli response in each of the one or more subjects, wherein the stimuli response comprises one or more actions selected from the group consisting of shifting of timing of sleep, reducing sleep onset latency, enhancing sleep consolidation and reducing variability in sleep patterns.   
     
     
         50 . The method of  claim 48 , wherein the control unit actuates the olfactory dispensing unit as a function of time, according to a formulation, using a timing device configured to keep time, memory to store the formulation and data from the one or more sensors and other system components, using a processor to compute relevant parameters and adjust the formulation in real-time to control timing when the olfactory agents are dispensed and amounts indicating a quantity of the olfactory agents to dispense, wherein the olfactory dispensing unit is configured to dispense the olfactory agents using an actuator that uses at least one mechanism selected from the group consisting of electrical heating of olfactory agents comprising one or more liquids actuated by the control unit at specific times designated by the formulation to cause evaporation, ultrasonic nebulizers comprising a vibrating transducer actuated by the control unit, air-stream atomizers comprising an air-stream generator actuated by the control unit, and volatile substances stored in a container that is opened and closed by the control unit to respectively allow and prevent vapors of the olfactory agents to propagate out of the olfactory dispensing unit and into the environment of the one or more subjects. 
     
     
         51 . The system of  claim 48 , wherein the olfactory agents comprise one or more agents selected from the group consisting of central nervous system depressants and a central nervous system stimulators. 
     
     
         52 . A system for adjusting consciousness patterns and circadian states of one or more subjects, the system comprising:
 an olfactory dispensing unit configured to dispense olfactory agents;   a control unit configured to actuate the olfactory dispensing unit and store data from one or more sensors configured to perform one or more functions selected from the group consisting of estimating and tracking activity and inactivity data for the one or more subjects, collecting and monitoring consciousness patterns data for the one or more subjects, and quantifying measurements of circadian outcomes for the one or more subjects;   a user interface operative to receive control commands, input from a user, for using the control unit to actuate the olfactory dispensing unit to dispense the olfactory agents;   wherein the olfactory dispensing unit and the control unit are configured to be in electronic communication and wherein the user interface and the control unit are configured to be in electronic communication; and   wherein dispensing of the olfactory agents modulates a circadian phase and consciousness state of the one or more subjects in response to a condition of the one or more subjects and an environment of the one or more subjects.   
     
     
         53 . The system of  claim 52 , wherein the olfactory dispensing unit comprises one or more containers that store the olfactory agents, and one or more actuators that dispense the olfactory agents into the environment of the one or more subjects. 
     
     
         54 . The system of  claim 52 , wherein the control unit actuates the olfactory dispensing unit as a function of time, according to a formulation, using a timing device configured to keep time, memory to store the formulation and data from the one or more sensors and other system components, using a processor to compute relevant parameters and adjust the formulation in real-time to control timing when olfactory agents are dispensed and amounts indicating how much olfactory agents are dispensed, wherein the olfactory dispensing unit is configured to dispense olfactory agents using an actuator that uses at least one mechanism selected from the group consisting of electrical heating of olfactory agents comprising one or more liquids actuated by the control unit at specific times designated by the formulation to cause evaporation, ultrasonic nebulizers comprising a vibrating transducer actuated by the control unit, one or more solids in contact with a heating element actuated by the control unit at specific times designated by the formulation to delivery of olfactory agents, ultrasonic nebulizers comprising a vibrating transducer actuated by the control unit, air-stream atomizers comprising an air-stream generator actuated by the control unit, and volatile substances stored in a container that is opened and closed by the control unit to allow and prevent vapors of the olfactory agents to propagate out of the olfactory dispensing unit into the environment of the one or more subjects. 
     
     
         55 . The system of  claim 52 , wherein the consciousness patterns comprise the subjects' sleep/wake patterns; and
 wherein the olfactory agents modulate sleep/wake patterns of the one or more subjects.   
     
     
         56 . The system of  claim 52 , wherein the one or more sensors are configured to perform collecting and monitoring of consciousness patterns data for the one or more subjects, wherein the monitoring consciousness patterns data comprises using the sensors to quantify the sleep and circadian system of the one or more subjects by sensing at least one signal selected from the group consisting of rest and activity cycles using actigraphy, signals using polysomnography, skin temperature, sleep onset time and duration, environmental light exposure, total light dosage received by the one or more subjects over a period of time, pulse oximetry, blood oxygen saturation levels, sweat and other skin secretions of the one or more subjects, and biofeedback signals indicative of sleep patterns of the one or more subjects. 
     
     
         57 . The system of  claim 56 , wherein the control unit uses consciousness patterns data of each of the one more subjects to optimize a formulation of the olfactory agents in real-time to provide cues to achieve a stimuli response in each of the one or more subjects, wherein the stimuli response comprises one or more actions selected from the group consisting of shifting of timing of sleep, adjusting circadian phase, enhancing alertness, enhancing performance, reducing sleep onset latency, enhancing sleep consolidation and reducing variability in sleep patterns and adjusting mood. 
     
     
         58 . The system of  claim 52 , further comprising at least one smart olfactory dispensing unit and software that tracks sleep history information of the one or more subjects, then sets a sleep-and-wake schedule for the one or more subjects and designates specific olfactory agents assigned to activity events selected from the group consisting of bedtime, risetime, nap time, awake time and combinations thereof, wherein the olfactory agents will be automatically dispensed at specific times of day to facilitate at least one action selected from the group consisting of sleep, wake, increased energy, and relaxation, wherein the system uses algorithms to avoid habituation to olfactory agents relative to onset of activity events. 
     
     
         59 . The system of  claim 52 , wherein the one or more sensors are configured to sense the environment of the one or more subjects by directly measuring the concentration of olfactory agents in air of the environment of the one or more subjects allowing the system to control a quantity of olfactory agents present in the environment of the one or more subjects and wherein the one or more sensors comprise a sensor selected from the group consisting of sensors configured for estimating concentrations in air for certain specific gases, sensors configured for estimating concentrations in air for volatile organic compounds, sensors that map aromas to images and combinations thereof. 
     
     
         60 . The system of  claim 52 , wherein a formulation comprises a list of times and desired concentrations of the olfactory agents at each time, wherein the concentrations of olfactory agents for use the formulation are determined from measured amounts of the olfactory agents absorbed by the one or more subjects over a certain exposure period, and wherein concentrations of olfactory agents for use in the formulation are measured using absolute units, empirical units and combinations thereof. 
     
     
         61 . The system of  claim 52 , wherein the control unit actuates the olfactory dispensing unit to dispense olfactory agents with output and intensity based upon measurements of circadian outcomes and application of machine learning techniques to indirectly infer adequate concentrations of a formulation and the olfactory agents in an environment of the one or more subjects. 
     
     
         62 . The system of  claim 52 , wherein the olfactory dispensing unit and the control unit are both contained within a physical device that further comprises a smart plug and wireless communication unit, and wherein a formulation is stored in memory of the control unit controlling dispensing of the olfactory agents and the control unit is controlled remotely using wireless electronic communication sent from a separate device comprising the user interface configured to receive input from the user to modify parameters of the system and adjust the formulations. 
     
     
         63 . The system of  claim 52 , wherein the control unit is physically separated from the olfactory dispensing unit and communicates electronically with the olfactory dispensing unit using wired or wireless technologies, wherein the control unit uses processors, memory and dedicated software that control the system and the control unit is physically connected to the user interface configured to receive input from the user to modify parameters of the system and adjust the formulations. 
     
     
         64 . The system of  claim 52 , wherein the control unit, the olfactory dispensing unit and the one or more sensors communicate electronically using transceivers, wireless communication units and wireless routers configured to operate using wireless technology standards selected from the group consisting of Bluetooth, Bluetooth low energy (BLE), Zigbee, Wi-Fi, infrared, near field communication and combinations thereof. 
     
     
         65 . The system of  claim 52 , further comprising a fan, configured to circulate air through the system. 
     
     
         66 . The system of  claim 52 , wherein the olfactory agents comprise one or more agents selected from the group consisting of central nervous system depressants and a central nervous system stimulators. 
     
     
         67 . The system of  claim 52 , wherein one or more subjects are human.