System and method for monitoring consciousness-altering therapy drug sessions

Abstract

A system for monitoring a patient during an altered consciousness therapy drug treatment session, the system including a data collection module in electronic communication with a network server for storing data in a non-transitory computer readable medium for monitoring the patient's health during and after the treatment session. A method of using the system in treating a patient by continuously, continuously or at the discretion of a medical professional, monitoring the patient's health during the altered consciousness therapy drug treatment session through one or more wearable devices in electronic communication with a facilitator mobile device and a patient mobile device, and by continuously monitoring the patient's health after the treatment session using the wearable devices.

Description

Technical Field

[0001] Background of the Invention 1. Technical Field The present invention relates to devices and methods for monitoring a patient during the administration of a prescription therapy drug known to have a consciousness-altering effect that requires monitoring for safety and efficacy.

Background Art

[0002] 2. Background Art There are many different prescription therapy drugs that have a consciousness-altering effect and require monitoring for safety and efficacy. One particular group of these therapy drugs is the class commonly referred to as hallucinogens. Hallucinogens are substances that can cause subjective effects such as dream-like consciousness alteration, emotional changes, improved introspective ability, visual imagery, pseudo- and actual hallucinations, synesthesia, changes in temporal and spatial perception, mystical experiences, out-of-body experiences, and ego dissolution (Liechti, 2017; Passie, Halpern, Stichtenoth, Emrich & Hintzen, 2008). Hallucinogens are used individually to assist in psychotherapy for many conditions including anxiety, depression, addiction, personality disorders, etc., and can also be used to treat other disorders such as cluster headaches and migraines (Passie et al., 2008; Hintzen et al., 2010; Nichols, 2016; Liechti, 2017).

[0003] Currently, during a treatment session, a patient is administered a consciousness-altering therapy drug such as a hallucinogen and is continuously monitored by a medical professional throughout its period of action. The patient is often encouraged to listen to music, be blindfolded, remain introspective and emotionally open, and pay attention to thoughts and memories. Psychotherapy can be provided before, during, and / or after the treatment session (Schenberg, Front Pharmacol. 2018; 9:733).

[0004] Because therapy sessions can last from 30 minutes to 12 hours, the number of sessions a healthcare professional can provide in a day is limited. While many people could sustainably benefit from such psychotherapy, its availability is restricted by the time required for healthcare professionals to monitor patients and the limited number of properly qualified and trained healthcare professionals.

[0005] A patient monitoring system is any device that allows a healthcare provider to monitor several aspects of a patient's health. Typically, the device includes sensors for detecting specific health parameters and wiring / electronic circuits for relaying the information to a processing unit and screen to display the parameter readings. Such devices include ECG devices, thermometers, pulse oximeters, capnography devices, blood pressure monitors, and the like.

[0006] Remote patient monitoring systems allow healthcare providers to monitor patients remotely, i.e., outside of the hospital or clinic. These devices can collect, store, and transmit data about patients to healthcare providers. Healthcare providers can review the collected data and make recommendations for patients requiring treatment. Devices include health and fitness trackers, wearable cardiac monitors, and blood glucose monitors.

[0007] Remote patient monitoring offers several advantages. By providing healthcare providers with real-time health data, they can understand the patient's current health status, assess their safety, and make informed decisions and adjustments regarding medication or drug type. Patients may need to visit the doctor's office less often. In many cases, patients can view their health results on a smartphone application and thus be aware of their own health. It also allows healthcare providers to monitor more patients at once. [Overview of the project] [Problems that the invention aims to solve]

[0008] To ensure more patients receive treatment, methods for monitoring patients who take hallucinogens or other consciousness-altering drugs are still needed. [Means for solving the problem]

[0009] Summary of the Invention The present invention provides a system for monitoring a patient during a consciousness-altering therapy drug treatment session, and includes a data acquisition module that electronically communicates with a network server to store data in a non-temporary computer-readable medium in order to monitor the patient's health status during and after the treatment session.

[0010] The present invention provides a method for using a system in patient treatment, generally by continuously, sequentially, or at the discretion of a medical professional, monitoring the patient's health status during a consciousness-altering therapy drug treatment session through one or more wearable devices and a patient mobile device that electronically communicate with a facilitator mobile device, and by continuously monitoring the patient's health status after the treatment session using a wearable device.

[0011] Description of the drawing By considering the attached drawings in conjunction with the following detailed description, the present invention will be better understood, and other advantages of the present invention will be easily grasped. [Brief explanation of the drawing]

[0012] [Figure 1] This is a flowchart illustrating the movement of information within the system. [Figure 2] This is a more detailed diagram of the system's components and data. [Figure 3] This is a screenshot of the facilitator's pre-session checklist. [Modes for carrying out the invention]

[0013] Detailed description of the invention The present invention generally provides a system 10 (shown in Figure 1) for monitoring a patient's health status during a consciousness-altering therapy drug treatment session. System 10 includes a data acquisition module 12 that electronically communicates with a network server 14 to store data in a non-temporary computer-readable medium. System 10 enables continuous monitoring of both patients at the treatment center and patients at home or other locations away from the treatment center after a treatment session. System 10 also enhances the ability of the administering healthcare professional to determine, in combination with clinical judgment, when the patient is no longer effectively affected by the therapy drug and when the treatment session can be terminated.

[0014] Most commonly, System 10 monitors the patient's health status, including the patient's response to the consciousness-altering therapy drug, both during and immediately after the therapy session. System 10 can monitor for adverse events (including negative emotional valence and anxiety) that may require close attention or care of the patient, as well as changes in the scope of the therapy session involving consciousness-altering effects or the therapy approach.

[0015] More specifically, the data acquisition module 12 includes patient-related devices, including a patient mobile device 16 (such as a smartphone or tablet), at least one wearable device 18 (such as a smartwatch or fitness band), a sound system 20, and a blood pressure monitor 22. The patient mobile device 16 and the wearable device 18 provide continuous passive data collection (such as voice, exercise, activity, stress level, heart rate, and combinations thereof).

[0016] The data acquisition module 12 also includes a facilitator mobile device 24 that electronically communicates with patient-related devices, which the session facilitator can use to monitor the patient. The facilitator mobile device 24 provides audio and video feeds, ePRO, eCOA, EMA, ClinRO, EHR / EMR, cognitive tasks, and therapy notes. The facilitator mobile device 24 may include an application (or “app”) that provides guidance throughout the therapy session.

[0017] The network server 14 further includes a backend with an API, which includes a relational database 26 and external storage 28.

[0018] Figure 2 shows the types of data collected by system 10. The data acquisition module 12 can collect audio and music stream data using a microphone and speaker 30, motion and actigraphy using an accelerometer, gyroscope, and magnetometer 32, heart rate and blood pressure using a heart rate sensor 34 and blood pressure monitor 22, ePRO, eCOA, EMA, or ClinRO using a facilitator mobile device interface 36, and video and image streams using a camera 38. The network or local server 14 may include cloud storage facilities 40 and a data processing and analysis module 42.

[0019] A consciousness-altering therapy drug can be any therapy drug known to have a consciousness-altering effect that requires monitoring for safety and effectiveness. The consciousness-altering therapy drug used in the treatment session in the present invention can be, but is not limited to, lysergic acid diethylamide (LSD), psilocybin, psilocin, mescaline, 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), dimethyltryptamine (DMT), 2,5-dimethoxy-4-iodoamphetamine (DOI), 2,5-dimethoxy-4-bromoamphetamine (DOB), ibogaine, ketamine, their salts, their tartrates, their solvates, their isomers, their analogs, their homologs or their deuterated forms. The consciousness-altering therapy drug can be used for the treatment of any disease or symptom.

[0020] Generally, the present invention provides a method of using the system 10 in the treatment of a patient by continuously monitoring the patient's health status during a treatment session by a wearable device 18 and a patient mobile device 16 that communicate electronically with a facilitator mobile device 24, and by continuously monitoring the patient's health status after the treatment session using the wearable device 18.

[0021] More specifically, the method includes the steps of collecting baseline data from the patient using the facilitator mobile device 24, providing the patient with the wearable device 18, the patient mobile device 16 and the blood pressure monitor 22, administering a consciousness-altering therapy drug to the patient, the facilitator conducting a treatment session, continuously monitoring the patient using the wearable device 18 and the patient mobile device 16, conducting a post-session evaluation on the patient, and monitoring the patient after the session using the wearable device 18. These steps and additional steps that can be included in the method are further described in the following user flow.

[0022] The following details how the system 10 is used. It should be understood that all individual steps and components of the user flow to be described can be changed, omitted, and replaced with alternative forms.

[0023] User Flow: Session Facilitator The patient is diagnosed, hallucinogen-assisted therapy is proposed, and the patient consents. The schedule for the patient's first treatment visit is determined, and the patient enters the treatment facility.

[0024] Hardware and system checks are performed. The facilitator participates in the session with a pre-calibrated and pre-set device toolkit that includes the facilitator's mobile device 24. The patient is provided with the wearable device 18 of the smartwatch, the patient mobile device 16 (smartphone), and the blood pressure monitor 22. The facilitator checks that the devices are charged, checks that the devices are paired / synchronized, checks that the applications on the patient's devices are running / recording [status on the screen], and checks that the internet connection is functional [status on the screen].

[0025] The facilitator has an introductory chat with the patient about what happens while sitting.

[0026] The facilitator sets up the devices for the patient by placing the smartwatch on the patient's dominant hand and instructing the patient to put the smartphone in a pocket, pouch, or on a nearby table. These devices monitor the patient's actions and physiological state throughout the session (and after the session).

[0027] The facilitator can set up the session and be guided step-by-step by an application interface on the device. The facilitator enters their own ID (facilitator ID), selects a patient ID from a list or adds a new ID, confirms a pre-generated session ID, selects the session type (i.e., the type of consciousness-altering therapy drug such as ketamine, LSD, psilocybin, ibogaine, or others listed above), selects the medication, and further, the facilitator confirms that the environment is appropriate for the treatment (i.e., no flashing lights, no loud noises; this can be guided by an application on the facilitator's mobile device 24).

[0028] The facilitator performs a baseline assessment of the patient's psychological state, guided step-by-step by an application interface on the device, with an example checklist shown in Figure 3. The facilitator asks the patient to complete a series of digitized questionnaires or cognitive tasks (the specific set varies depending on the patient's diagnosis and treatment; for example, regarding anxiety, OASIS [anxiety], Q-LES-Q-SF [quality of life]). These may be ePRO, eCOA, EMA, or ClinRO. The responses to these questionnaires can be viewed on the facilitator's mobile device 24. The facilitator instructs the patient to assume a resting position and automatically acquires readings of the patient's heart rate (via smartwatch) and blood pressure (via Bluetooth®-enabled blood pressure monitor 22). Based on the data collected so far from the questionnaire responses, heart rate readings, blood pressure readings, and collected voice (by sentiment analysis), the facilitator can measure the patient's overall stress level. The facilitator can instruct the patient to perform a urine pregnancy test, and the facilitator can enter the results into an application on their device 24. The facilitator can also perform a drug abuse test, and the patient can look directly into the camera of the facilitator's mobile device 24. The drug abuse test can be performed by computer-based iris analysis, pupil analysis, facial analysis, behavioral analysis, questions from the facilitator, and / or blood or saliva drug tests. The facilitator reviews the aggregated results of the baseline check using an application on the facilitator's mobile device 24.

[0029] Next, there is a baseline check by a clinician. If the facilitator is actually a clinician (on-site), the facilitator conducts a final conversation with the patient on-site, and the conversation is recorded for sentiment analysis (i.e., analysis of the patient's voice pitch, intonation, and emotional tone, rather than the content). If a clinician is not on-site, the patient is instructed to video call with the clinician via the facilitator's mobile device 24.

[0030] Next, the facilitator administers a single dose of the consciousness-altering therapy drug to the patient.

[0031] A therapy session is conducted, and all steps are guided by an application on the facilitator's mobile device 24. The facilitator instructs the patient to lie down or assume another comfortable position. The facilitator provides a blindfold and Bluetooth®-enabled headphones containing various audio tracks (e.g., ambient sounds, white noise, nature sounds, various music styles, etc.). The facilitator recommends and provides support and / or therapeutic guidance to the patient to remain in this position throughout the session. Throughout the session, the patient is continuously monitored by a wearable device 18 (smartwatch) and the patient's mobile device 16 (smartphone). The following patient-centric data types are continuously collected: heart rate readings from the dominant hand, content-masked audio (processing only vocal emotion, voice pitch, intonation, and conversational emotion), movement from the dominant hand wrist and hip / hip (gyroscope, accelerometer, orientation, altitude), and overall stress level (composite). The facilitator can observe individual indicators in real time. The facilitator is notified if any indicator differs significantly from the baseline reading before administration. The facilitator can create notes within the app on their device 24 and tag important events in the session. Notes and readings from physiological and behavioral data are time-stamped and paired with the music the patient is listening to. The facilitator can review the session history. The application on the facilitator's mobile device 24 provides information on the session length [time since session ID input], estimated session duration (with given drug and dosage), estimated session end (with given drug and dosage), estimated intensity of administered therapeutic drug (with given drug and dosage), and estimated duration of consciousness-altering therapeutic drug experience stages / phases (with given drug and dosage) regarding initial stage, onset, peak, and comedown.

[0032] In the post-session evaluation, the facilitator instructs the patient to assume a resting position and can assess the patient's resting state by monitoring the patient's heart rate (via a smartwatch) and blood pressure (via a Bluetooth®-enabled blood pressure monitor 22). Based on data collected up to that point from questionnaire responses, heart rate readings, blood pressure readings, and collected voice (through sentiment analysis), the facilitator can measure the patient's overall stress level. All notes generated by the clinician are digitally processed, and highlights from the therapy session and the aforementioned important events are automatically extracted and visually presented in a timeline. The facilitator reviews the aggregated results of the baseline check within an application on their device 24.

[0033] There is a post-session release check by the clinician. If the clinician is the facilitator (on-site), the patient has a final discussion with the clinician on-site, and the conversation is recorded for sentiment analysis (i.e., pitch, intonation, and emotional tone, rather than content). If the clinician is not on-site, the patient is instructed to have a video call with the clinician.

[0034] If the patient is deemed clinically stable, the facilitator digitally signs the session report, the patient digitally signs the session report, and both the patient and the facilitator receive the report digitally to their respective email addresses. If the patient is deemed clinically unstable, the facilitator instructs the patient to remain in the session, and a post-session release check is repeated a few minutes later.

[0035] At the end of the session, the facilitator collects the facilitator's mobile device 24, blood pressure monitor 22, and the provided smartphone (patient mobile device 16). The facilitator provides the patient with a provided wearable device 18 (smartwatch) for continuous monitoring of heart rate and overall activity, and a link to a BYOD mobile application for reporting adverse events. After the session, the facilitator can review and share the automatically generated session report, add a written report to the automatically generated report, review session highlights [tagged important events during the session, e.g., points of increased heart rate / stress or goal notes and related metadata], and review the session history.

[0036] User flow: Clinician If the clinician is the session facilitator (i.e., the clinician is in a session), the user flow for the session facilitator described above applies. If the clinician is not the session facilitator (i.e., the clinician is not in a session), there is an additional user flow.

[0037] Prior to the session, the clinician receives a summary of the patient's baseline assessment, including questionnaire responses, heart rate readings, blood pressure readings, overall stress levels, drug test results, and pregnancy test results. The clinician also receives notification regarding a pre-session video call with the patient (supported by a facilitator on-site).

[0038] The clinician initiates a video call with the patient to perform a pre-session assessment and approve the administration of the medication.

[0039] During the session, the clinician will receive notifications of important events in the session, and the facilitator and / or patient can contact each other via video call at any time.

[0040] After the session, the clinician receives a summary of the patient's post-session assessment, including the patient's heart rate readings, blood pressure readings, and overall stress level, along with aggregated notes and session highlights. The clinician receives notification regarding a post-session release video call with the patient (supported by a facilitator on-site). The clinician initiates the video call with the patient and approves the patient's release once they determine the patient is clinically stable. After the session, the clinician may review and share the automatically generated session report, add a written report to the automatically generated report, review session highlights [tagged key events during the session, e.g., points of increased heart rate / stress or target notes and associated metadata], and review the session history.

[0041] User flow: Patient The patient is diagnosed, and therapy using consciousness-altering medications is proposed and agreed upon. A schedule is set for the patient's first treatment visit. The patient visits, undergoes a baseline assessment, and has an introductory discussion with the facilitator / clinician about what will happen during the sessions.

[0042] Patients are provided with a wearable device 18 (smartwatch) and a patient mobile device 16 (smartphone to be kept in a pocket, pouch, or placed on a nearby table).

[0043] The patient undergoes baseline measurements to assess their current condition. The patient completes a series of digitized questionnaires (the specific set varies depending on the patient's diagnosis and treatment). These may be ePRO, eCOA, EMA, or ClinRO. The patient is instructed to assume a resting position, and the facilitator can assess the patient's resting state by monitoring heart rate (via a smartwatch) and blood pressure (via a Bluetooth®-enabled blood pressure monitor 22). Based on data collected up to that point from questionnaire responses, heart rate readings, blood pressure readings, and collected voice (by sentiment analysis), the patient's overall stress level can be measured. The patient may undergo a urine pregnancy test and provide the results to the facilitator. The patient is instructed to look directly into the camera 38 on the facilitator's mobile device 24. Drug abuse testing can be performed by iris analysis, iris analysis logic, facial analysis, questions from the facilitator, and / or blood or saliva drug tests.

[0044] During baseline checks with the clinician, if the clinician is the facilitator (on-site), the patient will have a final discussion with the clinician on-site, and the conversation will be recorded for sentiment analysis (i.e., pitch, intonation, and emotional tone, rather than content). If the clinician is not on-site, the patient will be instructed to have a video call with the clinician.

[0045] Next, the patient takes a single dose of consciousness-altering therapy medication provided by the facilitator.

[0046] The session begins, and the patient is instructed to lie down or assume another comfortable position. The patient may be blindfolded. The patient may receive Bluetooth®-enabled headphones containing various audio tracks (e.g., ambient sounds, white noise, nature sounds, various music styles, etc.). The patient is encouraged to maintain this position throughout the session, but is free to move around or talk to the facilitator if necessary. Throughout the session, the patient receives therapeutic guidance and is continuously monitored by a smartwatch and smartphone. The following patient-centered data types are continuously collected: heart rate (dominant hand), content-masked audio (processing only vocal emotion, voice pitch and intonation), movement from the dominant hand wrist and hip / hip (gyroscope, accelerometer, orientation, altitude), and overall stress level (composite).

[0047] In the post-session assessment, the patient is instructed to assume a resting position, and the facilitator can assess the patient's resting state by monitoring heart rate (via a smartwatch) and blood pressure (via a Bluetooth®-enabled blood pressure monitor 22). Based on data collected up to that point from questionnaire responses, heart rate readings, blood pressure readings, and collected voice (by sentiment analysis), the patient's overall stress level can be measured. In the post-session check with the clinician, if the clinician is the (on-site) facilitator, the patient has a final discussion with the clinician on-site, and the conversation is recorded for sentiment analysis (i.e., pitch, intonation, and emotional tone, rather than content). If the clinician is not on-site, the patient is instructed to video call with the clinician. If the patient is deemed clinically stable, the patient is instructed to digitally sign the hallucinogen session report and receive the report digitally at their email address. If the patient is deemed clinically unstable, the patient is instructed to remain in the session, and the post-session check is repeated a few minutes later.

[0048] The patient completes the session and possesses a provided wearable device (smartwatch) to continuously monitor their heart rate and overall activity. The patient downloads a BYOD app to report any adverse events.

[0049] Table 1 provides functional level specifications for the components of System 10 and their associated applications.

[0050] [Table 1]

[0051] Additional metadata related to device status, errors, battery level, etc., is also collected. The combined motion data collected from smartphones and wearables is a signal, which is a processed data stream automatically calculated by the device's operating system, and includes redundant information about the device's sensor data (accelerometer, gyroscope, magnetometer).

[0052] The following is an overview of the data types categorized by reading phase.

[0053] Baseline assessment (read-only): urine pregnancy test (facilitator input), experiments: drug abuse iris analysis (iris analysis logic or facial analysis), and eCOA, ePRO.

[0054] Continuous monitoring (during the session): heart rate (dominant hand), voice, movement (gyroscope, accelerometer, altitude, activity), stress level (combined), and facilitator / clinician notes.

[0055] Baseline and release evaluation readings: blood pressure monitor, heart rate readings, and video call.

[0056] Continuous monitoring (post-session): heart rate (dominant hand), exercise (gyroscope, accelerometer, altitude, activity), and reported adverse events.

[0057] The following are device and data management protocols.

[0058] Smartphone data recording protocol: The application on the smartphone continuously records data from the moment the patient registers with the application until the battery runs out, the device shuts down, or the patient logs out of the device. The application also records while charging. After a device restart triggered by the user or low battery level, data collection must be manually initiated.

[0059] Smartphone Data Upload Protocol: Extensive battery profiling has shown that uploads do not have as significant an impact on battery life as, for example, file compression or writing to disk. The system has configurable data retention and upload periods. The system backs up recorded data on the device until the batch is successfully sent, and deletes the data batch only after successful upload is confirmed. Uploads from the smartphone to the server are performed via Wi-Fi and / or via a cellular data program. This system is optimized for Wi-Fi as the main upload channel. If Wi-Fi is unavailable (or the signal quality is unstable), the system sends the data batch via the cellular data program.

[0060] Wearable recording protocol: The application on the watch continuously records from the moment the patient registers with the application until the battery runs out or the device shuts down. The application also records while charging. After a device restart triggered by the user or low battery level, data collection must be manually initiated.

[0061] Wearable Data Upload Protocol: The system has configurable data storage and data upload periods. The system backs up recorded data on the device until the batch is successfully sent, and deletes the data batch only after the upload success is confirmed. Uploads from the watch to the server are performed via a Bluetooth® connection to the paired smartphone. If the paired smartphone is out of range, the watch remembers the authentication information for the Wi-Fi network used by the smartphone and attempts to upload autonomously. This system is optimized for Wi-Fi as the main upload channel. If Wi-Fi is unavailable (or the signal quality is unstable), the system sends the data batch via the cellular data program.

[0062] Device Charging Protocol: Since most therapy sessions utilizing altered consciousness take place during the day, the system and all devices are optimized for charging overnight or between sessions. Furthermore, it was desired that the necessary device management be coordinated with the facility's clinical staff shifts. This simplifies third-party annotations regarding the patient's physiological and psychological state and health status. However, future use cases are expected to require adjusting the device charging schedule to the patient's situation (e.g., withdrawal symptoms or clinical stability), so the system can be modified to accommodate various charging requirements or study designs.

[0063] System 10 is actively sending multiple alerts to the backend. None of these alerts are visible to the on-site device administrator or patient. The system alerts relate to crash analysis, system monitoring, data upload failures, network failures, and device power-offs.

[0064] System 10 can also provide additional functions. System 10 can provide automatic detection of mood fluctuations, early onset of panic attacks, and other psychological states and behavioral correlations with the altered consciousness effects of administered therapeutic drugs. System 10 can provide continuous monitoring and real-time detection of adverse events related to altered consciousness therapy (during and between sessions). It may have the ability to automatically analyze clinician / facilitator notes and automatically identify, extract, and present key moments, comments, and highlights of treatment sessions. System 10 can automatically generate patient-specific and / or session-specific statistics. System 10 can provide monitoring for signs of abuse or dependence. System 10 can provide an automated drug dispensing system. System 10 can include a medication management tracking system. System 10 can provide automatic detection of inappropriate treatment environments. System 10 can provide a digitized clinician, facilitator, and field authentication system. System 10 can provide a treatment management system. System 10 can provide session scheduling, digital medical history, and audit trail interfaces.

[0065] The system 10 of the present invention has several advantages. A clinician is not required to conduct the treatment session, and a certified nurse or other facilitator can conduct the treatment session, as the clinician can remotely monitor the data and supervise the treatment session. If something significant happens during the treatment session, the facilitator can immediately review the data with the clinician. This allows the clinician to monitor not only one patient but multiple patients simultaneously. The collected data also makes it possible for the clinician to predict significant events, which gives the clinician time to adjust treatment or intervention. If significant effects exist or significant events are predicted after the treatment session, the clinician can review the data collected while the patient was at home and intervene as necessary. Long-term data collection on patients can be used to build a patient database and predict the outcomes of new patients based on similar patients in the database.

[0066] By providing clinicians with real-time health data, they can recognize the patient's current health status, assess patient safety, and make informed decisions and adjustments regarding medication or drug type. This reduces the number of times patients need to visit the doctor's office. Patients can view their health results on a smartphone application and thus become more aware of their own health.

[0067] The present invention will be described in further detail with reference to the following experimental examples. These examples are provided for illustrative purposes only and are not intended to limit the invention unless otherwise specified. Therefore, the present invention should not be construed as being limited to the following examples, but rather as encompassing all variations that become apparent as a result of the teachings provided herein.

[0068] Throughout this application, various publications, including U.S. patents, are referenced by author, publication year, and patent number. A complete list of these publications is provided below. To further describe the state of the art in the field relating to this invention, the entirety of these publications and patent disclosures are incorporated into this application by reference.

[0069] While the present invention has been described illustratively, please understand that the terms used are intended for illustrative purposes only, not as limitations.

[0070] In light of the above teachings, it is clear that many modifications and variations of the present invention are possible. Therefore, it should be understood that the present invention can be implemented in ways other than those specifically described, within the scope of the appended claims.

Claims

1. A system for monitoring patients during consciousness-altering therapy drug treatment sessions, A data acquisition module communicates electronically with a network server to store data in a non-temporary computer-readable medium in order to monitor the patient's health status during and after the aforementioned treatment session. Includes, The data acquisition module includes a patient-related device comprising a patient mobile device, at least one wearable device, a sound system, and one or more blood pressure monitors, and a facilitator mobile device that electronically communicates with the patient-related device. system.

2. The system according to claim 1, wherein the patient-related devices include a patient mobile device, at least one wearable device, a sound system, and a blood pressure monitor.

3. The system according to claim 2, wherein the patient mobile device is selected from the group consisting of smartphones and tablets, and the at least one wearable device is selected from the group consisting of smartwatches and fitness bands.

4. The system according to claim 1, wherein the facilitator mobile device provides audio and video feeds, digitized questionnaires, electronic health records, electronic medical records, cognitive tasks, and therapy notes.

5. The system according to claim 1, wherein the facilitator mobile device includes an application stored on a non-temporary computer-readable medium for guiding the facilitator using the facilitator mobile device throughout the treatment session.

6. The system according to claim 1, wherein the network server includes a backend equipped with an API, which includes a relational database and external storage.

7. The system according to claim 1, wherein the data acquisition module acquires audio and music stream data using a microphone and speaker, motion and actigraphy using an accelerometer, gyroscope and magnetometer, heart rate and blood pressure using a heart rate sensor and blood pressure monitor, digitized questionnaires using a facilitator mobile device, and video and image streams using a camera.

8. The system according to claim 1, wherein the consciousness-altering therapeutic agent is selected from the group consisting of lysergic acid diethylamide (LSD), psilocybin, psilocin, mescaline, 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), dimethyltryptamine (DMT), 2,5-dimethoxy-4-iodoamphetamine (DOI), 2,5-dimethoxy-4-bromoamphetamine (DOB), ibogaine, ketamine, salts thereof, tartrates thereof, solvates thereof, isomers thereof, analogs thereof, homologs thereof and deuterated forms thereof.

9. The system according to claim 1, providing functions selected from the group consisting of mood swings, early onset of panic attacks, and other psychological states and behavioral correlations to the consciousness-altering effects of the consciousness-altering therapy drug; continuous monitoring and real-time detection of adverse events related to consciousness-altering therapy; automatic analysis of clinician / facilitator notes; the ability to automatically identify, extract and present important points, comments and highlights of the therapy session; the ability to automatically generate patient-specific and / or session-specific statistics; monitoring for signs of abuse or dependence; an automated drug delivery system; a medication management tracking system; automatic detection of inappropriate therapy environments; a digitized clinician, facilitator and field authentication system; a treatment management system; a session scheduling system; a digital medical history and audit trail interface; and combinations thereof.

10. A method for processing information for using a monitoring system in the treatment of a patient, The aforementioned monitoring system The steps include continuously or sequentially monitoring the patient's health status during a consciousness-altering therapy drug treatment session through one or more wearable devices communicating electronically with a facilitator mobile device and a patient mobile device, The steps include continuously monitoring the patient's health status after the treatment session using one or more of the aforementioned wearable devices. An information processing method that performs [this action].

11. The step of continuously or continuously monitoring the patient's health condition during the consciousness alteration therapy drug treatment session is: The aforementioned monitoring system The steps include: collecting baseline data from the patient using a facilitator mobile device; A step in which the facilitator accepts the selection of a consciousness-altering therapy drug to be administered to the patient, The facilitator continuously monitors the patient during the treatment session using one or more wearable devices and the patient's mobile device, The step of performing a post-session evaluation on the aforementioned patient. The information processing method according to claim 10, including the method described in claim 10.

12. The information processing method according to claim 11, further comprising the step of recording a conversation with the patient while the clinician is checking the baseline data after the step of collecting the baseline data.

13. The information processing method according to claim 11, wherein, during a treatment session, an application stored on a non-temporary computer-readable medium on the facilitator's mobile device guides the facilitator throughout the treatment session.

14. The information processing method according to claim 11, further comprising the step of the monitoring system notifying the facilitator if any indicator differs significantly from the baseline data.

15. The information processing method according to claim 13, further comprising the steps of the monitoring system creating a memo and tagging important events in the treatment session in an application, in response to the facilitator's actions.

16. The information processing method according to claim 13, further comprising the step of providing information regarding the length of the session, the estimated duration of the session, the estimated end of the session, the estimated intensity of the consciousness-altering therapy drug administered, and the estimated duration of the consciousness-altering therapy drug experience stages / phases relating to the initial stage, onset, peak and comedown.

17. The information processing method according to claim 11, wherein the step of performing the post-session evaluation further includes, in response to the facilitator's actions, evaluating the patient's resting state by evaluating heart rate, blood pressure and overall stress level, digitally processing all notes generated during the session, and automatically extracting highlights and important events, and visually presenting them on a timeline on the facilitator's mobile device.

18. The information processing method according to claim 10, wherein the step of continuously monitoring the patient's health status after the treatment session includes the monitoring system continuously monitoring the patient's heart rate and overall activity using one or more wearable devices.

19. The information processing method according to claim 10, further comprising the step of continuously monitoring adverse events by the monitoring system.

20. The information processing method according to claim 10, wherein the one or more wearable devices and patient mobile devices collect continuous passive data selected from the group consisting of voice, exercise, activity, stress level, heart rate and combinations thereof.

21. The information processing method according to claim 10, wherein the consciousness alteration therapy agent is selected from the group consisting of lysergic acid diethylamide (LSD), psilocybin, psilocine, mescaline, 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), dimethyltryptamine (DMT), 2,5-dimethoxy-4-iodoamphetamine (DOI), 2,5-dimethoxy-4-bromoamphetamine (DOB), ibogaine, ketamine, salts thereof, tartrates thereof, solvates thereof, isomers thereof, analogs thereof, homologs thereof and deuterated forms thereof.

22. The information processing method according to claim 10, further comprising steps selected from the group consisting of: automatic detection of mood swings, early onset of panic attacks, and other psychological states and behavioral correlations to the altered state effects of administered altered state therapy drugs; continuous monitoring and real-time detection of adverse events related to altered state therapy; automatic analysis of clinician / facilitator notes and automatic identification, extraction, and presentation of key moments, comments, and highlights of the therapy session; automatic creation of patient-specific and / or session-specific statistics; monitoring for signs of abuse or dependence; provision of an automated drug delivery system; provision of a medication management tracking system; automatic detection of inappropriate therapy environments; provision of digitized clinician, facilitator, and field authentication systems; provision of a therapy management system, session scheduling, digital medical history, and audit trail interface; and combinations thereof.

23. The information processing method according to claim 10, wherein the patient mobile device is selected from the group consisting of smartphones and tablets, and the one or more wearable devices are selected from the group consisting of smartwatches and fitness bands.

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