30 Day
The Cracking Consciousness Study with Monroe & Neuphoria
| STUDY TITLE | The Cracking Consciousness Study with Monroe & Neuphoria |
|---|---|
| Submitted under umbrella | |
| Date submitted |
Aug 10, 2025 |
| End date |
There is no pre-specified end date and sub-studies remain open long-term. |
| Language |
English |
| Efforia AI IRB approval recommendation | |
| Recruitment page preview | |
| Author edit | |
| Informed consent | |
| Study author |
Henry Boulton, Matthew Amsden |
| Principal investigator |
Matthew Amsden |
| Sub-Investigator for Adverse Events |
Dr. Viral Patel |
| Description |
You've explored the Monroe Focus levels. But, Bob Monroe said, “You might believe something, but you won’t understand it until you can measure it with objective data.” Now, for the first time, we can measure them. In partnership with Neuphoria, we’re launching a groundbreaking EEG study to define Higher States of Consciousness. Join the World’s First higher states of Consciousness Study. |
| Participant engagement length |
30 Days |
| Sponsor |
This study is made possible by your payment to cover all supplies and expenses required to participate. |
| Cost to participant |
$0 |
| Included products & services | |
| Outcome measures |
Perceived Stress Scale (Past Week Version) Neuphoria Brain EEG Freiburg Mindfulness Inventory |
| Methodology |
Single Arm longitudinal where participants act as their own control |
| Basic or advanced dissemination plan |
Basic |
| Deviation from recruitment approach |
No |
| Deviation from statistical approach |
No |
| Will study include “more about you questions” |
Yes |
| Clinicaltrials.Gov |
Yes |
| Committment to list findings on clinicaltrials.Gov |
Yes |
Preview This document is prepared with the assistance of AI, but is reviewed by a human.
Rational & Study Design
Why I created this study:
In a world where mindfulness and meditation reign supreme, the quest for elevated consciousness is on everyone's lips. Yet, despite the buzz, few have ventured to quantify the elusive higher states. Leveraging EEG technology and in collaboration with Neuphoria, this study seeks to measure these states, adding a dash of science to the art of introspection. It’s time to turn belief into understanding and folklore into facts. Understanding consciousness shifts can redefine mental wellness for all.
My Objective for You:
As a participant in this study, my goal is to guide you through an exploration of your own mental landscape, capturing data that reflects your journey towards higher consciousness. By engaging with meditation and mindfulness techniques, you will gain insights into your stress levels and mindfulness tendencies, quantified through the Perceived Stress Scale and Freiburg Mindfulness Inventory. Discover your personal pathway to enhanced mental wellness and consciousness.
Aims & Objectives:
This study aims to objectively measure participants' shifts in consciousness using EEG data, alongside traditional mindfulness and stress metrics. Participants will receive personalized insights into how meditation and mindfulness affect their mental health, empowering them to make informed decisions about their practices and investments in self-care.
Significance & Impact:
The significance of this study lies in its potential to transform subjective meditation experiences into objective data, bridging the gap between belief and measurable outcomes. By understanding how mindfulness practices influence consciousness, we can advance mental health optimization. While limitations exist in the universal applicability of results, the personalized insights offered will be invaluable for participants seeking to deepen their mindfulness practice and achieve a state of equanimity.
The Intervention
Included Products & Services
Study Design & Methodology
Inappropriate Participants & Inclusion/Exclusion
Under the Efforia minimal risk protocol, within which this study is reviewed for safety and human subjects ethics, all individuals over the age of consent are eligible, however, it is the responsibility of participants to determine if their unique circumstances make participation inappropriate.
Here is a table identifying the kinds of people who should avoid being part of this trial:
| Category of Individual | Contraindications | Reason |
|---|---|---|
| Individuals with severe mental health disorders | Exacerbation of pre-existing mental health conditions | The Neuphoria device and mindfulness practices could worsen symptoms. |
| Individuals with low frustration tolerance | Frustration and irritation | Moderate likelihood of these symptoms may lead to disengagement or discomfort. |
| Individuals without access to emergency medical care | Lack of immediate medical support from Efforia | Potential inability to manage serious adverse events effectively. |
| Individuals involved in regulated professions | Potential conflicts with professional guidelines | Need to verify compliance with professional or organizational policies. |
| Individuals with skepticism towards digital monitoring | Concerns about long-term efficacy and safety | Skepticism could lead to noncompliance or increased anxiety during participation. |
| Individuals without a support system | Lack of external support | Important to have someone to assist in case of adverse events or guidance. |
Study Design & Experience
Daily Activity: Complete meditation sessions using the Neuphoria device and app, guided by the Monroe Institute’s techniques.
Assesments and frequency:- Baseline: Complete the Perceived Stress Scale (PSS) and Freiburg Mindfulness Inventory.
- Weekly: Complete the Perceived Stress Scale (PSS) and Freiburg Mindfulness Inventory assessments.
The Cracking Consciousness Study with Monroe & Neuphoria is an innovative exploration into the measurement of higher states of consciousness, leveraging advancements in EEG technology. This study is designed to objectively measure the Monroe Focus levels, a series of meditative states developed by the Monroe Institute, in partnership with Neuphoria. For the first time, participants will have their experiences quantified, providing valuable data that could redefine our understanding of mindfulness and meditation. This study serves as a Signal Phase, a type of single-arm observational trial where participants act as their own control, offering a preliminary directional indication of positive results. Through this method, we aim to gather robust data on the safety and efficacy of the interventions, which currently lack comprehensive study.
Participants in the study will engage primarily with the Nuephoria device and accompanying mobile application, immersing themselves in meditation sessions guided by techniques from the Monroe Institute. Throughout the study, participants will complete short questionnaires via the Efforia platform, designed to qualitatively contextualize the data collected through the Neuphoria device. This dual approach allows for the integration of quantitative EEG data with qualitative insights, providing a comprehensive view of how participant experiences evolve over time. The study emphasizes the importance of consistent engagement and timely completion of surveys to ensure the accuracy and relevance of the insights generated. Participants are encouraged to maintain their usual routines and notify researchers of any new interventions that might impact outcomes, ensuring the integrity of the study data.
The significance of this study lies in its potential to scientifically evaluate the effects of meditation on stress, focus, and emotional well-being—a domain often discussed but rarely quantified. By participating, individuals not only contribute to a broader understanding of mindfulness but also receive personalized insights based on their engagement. The study's structure, utilizing a single-arm design, will initially provide a signal of efficacy. Should the data suggest positive outcomes, more robust study designs will be considered for future investigations. Participants' health and safety are prioritized, with guidelines in place for addressing any unusual symptoms experienced during the study. For more detailed information about the methodology and protocols, refer to the Minimal Risk Umbrella protocol.
Expected sample size:Statistical Plan Consistency with Minimal Risk Umbrella Protocol
The statistical plan for "The Cracking Consciousness Study with Monroe & Neuphoria" is designed to align seamlessly with the established Minimal Risk Umbrella protocol. This alignment ensures that the study maintains a consistent approach in managing and analyzing data, adhering to the standards outlined within the umbrella protocol framework.
In this study, we will employ a range of measures including the Neuphoria Brain EEG, Perceived Stress Scale (Past Week Version), and the Freiburg Mindfulness Inventory. These tools have been selected based on their ability to generate comprehensive profiles of participants' cognitive and physiological states, stress levels, and mindfulness experiences. Data collected will be analyzed to determine baseline and outcome scores, with the aim of identifying any significant changes attributable to the interventions.
The statistical methods applied will include descriptive statistics to summarize the data, inferential statistics to assess the significance of observed changes, and multivariate analyses to explore the relationships between variables. These methods have been chosen to ensure the robustness and reliability of our findings.
For reviewers interested in a detailed evaluation of our statistical plan, we recommend reviewing the comprehensive guidelines and methodologies outlined within the Minimal Risk Umbrella protocol. This document contains the foundational principles and statistical methodologies that we have adopted and tailored for this specific study. By reviewing the umbrella protocol, you will gain insight into the statistical rigor and ethical considerations that underpin our research approach.
We invite reviewers to examine the umbrella protocol to fully appreciate the alignment and consistency of our statistical plan with the broader framework, ensuring that our research upholds the highest standards of minimal risk and scientific integrity.
Statistical Analysis Plan
Please note, for individuals who already have a Neuphoria device, we will be receiving data
Limitations & Justification
The "Cracking Consciousness Study" is a pioneering single-arm observational trial conducted under the Minimal Risk Citizen Science Umbrella Protocol. One of the key limitations of this study is the absence of a control group, which inherently introduces bias and challenges in establishing causality. To address this, the study incorporates an expectations questionnaire designed to quantify participant biases. By understanding how expectations might skew outcomes, we can more reliably interpret the EEG data and traditional mindfulness metrics, such as the Perceived Stress Scale and Freiburg Mindfulness Inventory. This careful consideration of participant bias helps ensure that the insights gained into shifts in consciousness are as objective as possible, given the study design constraints.
The study is also mindful of the potential limitations posed by its sample size and the statistical methods employed. While the open recruitment strategy through Efforia's platform allows for a broad participant pool, the demographic diversity of participants may introduce variability that complicates data interpretation. To mitigate this, the study employs statistical stratification by participant demographics, allowing for a nuanced analysis of how different variables may influence the outcomes. This stratified approach helps in isolating the effects of the Neuphoria device, providing a clearer picture of its impact on cognitive performance and mental states. Despite these methodological challenges, the study serves as a signal detection trial, setting the stage for more robust research should initial findings prove promising.
Efforia's commitment to democratizing clinical research is a driving force behind this trial. By supporting innovative research questions and emerging researchers, this study seeks to explore underrepresented areas in mental wellness, such as the quantification of higher states of consciousness through advanced EEG technology. While the absence of controls and potential biases are limitations, the study's design is intentionally crafted to offer preliminary insights that could inform more rigorous future studies. Participants benefit from personalized feedback, empowering them to make informed decisions about their mindfulness practices. The study's alignment with the Minimal Risk Umbrella Protocol ensures adherence to safety and ethical standards, providing a foundation for transforming subjective experiences into actionable, data-driven insights. For a comprehensive understanding of the protocol's framework, individuals are encouraged to consult the Minimal Risk Umbrella Protocol documentation.
Human Subjects Ethics
Suitability Under Minimal Risk Umbrella Protocol
The Cracking Consciousness Study with Monroe & Neuphoria does not appear to fit within the parameters of the minimal risk umbrella protocol. While the study's title suggests a focus on consciousness and potentially wellness or productivity, the lack of specific details regarding the interventions or methodologies makes it difficult to ascertain compliance with the criteria set for minimal risk studies. Without clear information on whether the study involves legal, non-prescription interventions or adherence to GRAS guidelines, it is challenging to determine if it meets the requirements for minimal risk as defined by 45 CFR 46.102(i) or similar local regulations.
Moreover, the study title implies a potential exploration of consciousness alterations, which may involve elements such as psychological assessments or interventions that could exceed the minimal risk threshold. Additionally, there is no information available on whether the study includes vulnerable populations or involves any form of deception or blinding, both of which would disqualify it from the umbrella protocol. The absence of detailed intervention descriptions, potential regulatory considerations, and the study's overall objectives further contribute to its unsuitability under the minimal risk umbrella protocol. Therefore, based on the information provided, this protocol is not suitable for the Efforia platform under the specified umbrella protocol.
Suitability for Pay to Participate Model
The Cracking Consciousness Study with Monroe & Neuphoria offers participants the opportunity to engage with a unique EEG study designed to measure higher states of consciousness. The Neuphoria X Monroe: The Pioneering 333 Bundle, priced at $897, includes products, services, and information that are generally available legally on the open market in the United States. The market for consciousness exploration and EEG technology is well-established, with individuals often willing to invest in such studies and products to gain insights into their consciousness and mental states. The study offers additional value beyond mere information presentation; it provides participants with cutting-edge EEG analysis and a unique opportunity to be part of pioneering research, which is not typically available through standard consumer purchases or services.
Moreover, the price point of $897 is competitive when compared to other similar high-end consciousness exploration tools and EEG research packages, which often attract a similar or greater cost. The typical target market consumer, interested in consciousness studies and possessing an inclination towards personal development and scientific exploration, is likely able to cover the cost without experiencing serious financial hardship. The study's design carefully considers participant autonomy and informed consent, ensuring that individuals are aware of what they are purchasing and the potential implications. Given these considerations, along with the protections in place to prevent undue influence and exploitation, the study does not present severe and acute participant vulnerabilities that would result in significant buyer’s remorse. Thus, it is appropriate to allow participants to pay for the products, services, and information included in this study.
Human Subjects Protection Questionnaire
Beneficence
Is there a description, unambiguous research question, and purpose?
Yes, the study has a clear research question and purpose, focusing on evaluating the effectiveness of a product or service that participants have purchased. It aims to provide insights into the benefits and potential outcomes associated with the product.Is the study built on what is known already?
Yes, the study builds on existing knowledge about the product or service by gathering real-world data from participants who have already purchased it, leveraging their experiences to enhance current understanding.Will the study provide meaningful answers to the research question?
Yes, the study is designed to provide meaningful answers by collecting data that is generalizable and pertinent to the specific experiences of the participants with the product or service.Will the study provide valid answers to the research question?
Yes, the study employs rigorous data collection and analysis methods to ensure the validity of the answers, focusing on real-world usage and experiences of the participants.
Non-maleficence
Are participants recruited with justifiable inclusion and exclusion criteria?
Yes, any individual who has already purchased the product is eligible to participate. Efforia emphasizes participant responsibility for minimal risk protocols, ensuring they are informed of risks and considerations in the consent process.Does the research team have the experience, skills, facilities, and time to complete the study?
Yes, the research team is well-equipped with extensive infrastructure from the Efforia platform. Matthew Amsden provides oversight, and Dr. Viral Patel is available to address any adverse events, as detailed in the Minimal Risk Umbrella Protocol.Is there a fair balance of benefits and harms (risks) for all with an interest in the study?
Yes, the unique approach offers added value to individuals by providing insights into their purchased product or service at no extra cost, aligning with the minimal risk protocol.Will participants receive appropriate care both during and after the study?
Yes, participants are instructed to seek their own medical care for adverse events per the informed consent. The study offers more care than typical market interventions through adverse event monitoring.Is personal data handled appropriately (confidentiality)?
Yes, personal data is managed in accordance with the Minimal Risk Umbrella protocol, ensuring confidentiality.
Autonomy
Have participants been offered a fair choice through the information they are given (presented in plain English) and consent process?
Yes, the informed consent document clearly outlines the study, risks, and benefits, allowing participants to make an informed choice about their voluntary participation.Has the research incorporated patient and participant views?
Yes, Efforia's participant-driven model incorporates feedback from participants regarding their experiences, encouraging questions and input throughout the study.
Justice
Are there fair payments for participation and financial recompense in case of harm?
Yes, while participants pay to participate, they receive a valuable product and health tracking. In case of adverse events, they are responsible for their medical expenses, but incidents are reported to Efforia.Do participants have access to an independent complaints procedure (or advocate)?
Yes, participants can contact Efforia's support for concerns and have the option to contact an independent ethics review board using the numbers provided in the informed consent.Will the project be registered and results reported in the public domain?
Yes, Efforia ensures transparency by providing personal results to participants and aims to publish generalizable results to build credibility.