What You Need to Know to Participate
This document provides information to help you decide whether to join this research study. It is important you understand the responsibilities, risks and benefits of participating.
Summary Information to Help you Decide Whether to Join this Study
INFORMED CONSENT DOCUMENT AGREEMENT TO BE IN A RESEARCH STUDY
| Study Title | The Cracking Consciousness Study with Monroe & Neuphoria |
|---|---|
| Study Author | Henry Boulton; Matthew Amsden (Principal Investigator); Sub‑Investigator for Adverse Events: Dr. Viral Patel |
| Sponsor | This study is made possible by your payment to join. |
| Cost of Products, Services & Information to Participant | $897 (USD) |
| Included Products & Services | Neuphoria X Monroe: The Pioneering 333 Bundle — Neuphoria EEG headband; 30‑day Higher States of Consciousness (HSC) training protocol; real‑time cloud reporting; preloaded Monroe Focus Level meditations; neuro‑adaptive feedback; private community access; expert Q&As; early feature access; digital certificate. |
| Outcome Measures | Neuphoria Brain EEG; Perceived Stress Scale (Past Week Version); Freiburg Mindfulness Inventory. |
| Contact | help@efforia.com |
Introduction & Summary
Welcome to a 30‑day research study hosted on the Efforia platform. This study explores meditation‑related “higher states of consciousness” using an at‑home EEG headband (Neuphoria) and short questionnaires. The goal is to help you see your own results and also contribute to overall findings for everyone in the study.
Your participation is voluntary. You may decide not to join, or you may leave the study at any time without penalty. Use this information to decide if this study is right for you. Please get answers to all your questions before you join.
Efforia is a citizen science platform where studies are effectively sponsored by, you, the participants. Unlike traditional research studies, you pay for all the supplies, services, information, and tools needed for participation in one transaction. This makes studies possible that might not be otherwise.
Although you could buy these products and services separately for a similar cost, Efforia bundles them into one purchase for convenience. Efforia organizes these items and provides instructions to create a comprehensive, data-driven research experience. This setup allows you to track and understand the impact on your own life via detailed outcome reports, making informed personal health decisions easier. It also advances broader research findings, benefiting others who might not afford such purchases without guaranteed results.
Efforia is committed to equitable inclusion. If the cost is too high for you, click the large Efforia logo at the top of the screen to explore other protocols. Efforia offers protocols on various topics at different price points, including free options, so you can find one that suits your goals and budget.
Purpose of the Study
This study aims to measure changes that may occur during meditation practice and guided audio sessions known as Monroe “Focus levels.” We will combine:
- Neuphoria Brain EEG (electroencephalography): a non‑invasive method that uses sensors on the skin to detect brainwave activity. No electrical stimulation is delivered by the device.
- Perceived Stress Scale (Past Week Version): a short questionnaire that asks how often you felt stressed in the last 7 days.
- Freiburg Mindfulness Inventory: a brief, validated survey that assesses mindfulness in daily life.
Products & Services: The Neuphoria EEG headband and app provide real‑time cloud reporting and neuro‑adaptive feedback while you listen to Monroe Institute meditations. You also receive a structured 30‑day training plan, community access, and expert Q&As.
Why this matters: By pairing EEG with stress and mindfulness surveys, we hope to better understand how meditation practices relate to measurable brain and well‑being changes. Your results help you make informed choices for your own practice and contribute to broader learning.
What You Will Do as Part of this Study
“While participating in this research study, you will need to:
- Be willing and able to follow the study directions and procedures
- Tell Efforia about any side effects or problems by communicating with help@efforia.com or online chat.
- Ask questions as you think of them, via help@efforia.com or online chat.
- Inform Efforia if you change your mind about staying in the study. You may leave the study at any time by communicating with help@efforia.com or chat.”
Enrollment steps: After you complete consent, enrollment, and payment, you will enter your personal details, shipping details (for the device), and communication preferences. You will then receive access to your study tasks in Efforia and setup instructions for your Neuphoria headband and app.
During the 30‑day study you will:
- Use the Neuphoria EEG headband with the Monroe Focus Level meditations most days (aim for daily).
- Complete baseline questionnaires: Perceived Stress Scale and Freiburg Mindfulness Inventory.
- Complete weekly follow‑up questionnaires: Perceived Stress Scale and Freiburg Mindfulness Inventory.
- Complete brief safety check‑ins and any in‑app prompts.
- Maintain your usual routine. Tell us if you start any new major interventions (e.g., new medications, intensive new practice) that could change your results.
The Risks, Discomforts & Benefits of Being in this Study
All studies have risks and possible benefits. Please review these carefully to decide if this is right for you.
Possible Serious Adverse Events & Side Effects
| Risk name | Risk likelihood | Summary |
|---|---|---|
| Skin irritation or pressure marks | Low | Wearing a headband sensor can cause temporary redness or irritation on the skin. |
| Headache or fatigue | Low | Concentration during sessions or device fit may lead to mild headache or tiredness. |
| Anxiety or emotional discomfort | Low to Medium | Focusing inward or tracking data may temporarily increase stress or worry. |
| Dizziness or lightheadedness | Very Low | Uncommon reactions to posture, breathing, or prolonged sessions may occur. |
| Triggering symptoms in seizure‑prone individuals | Unknown | Those with seizure disorders should consult a clinician before joining. |
| Device malfunction or data loss | Low | As with any electronics, hardware or software issues could interrupt use or recording. |
| Privacy and data security risks | Low to Medium | No system is 100% risk‑free; see Privacy & Security Risks below. |
Some People May be at Increased Risk
Some people may be at higher risk from this study and should not join before speaking with a medical or other professional who knows your specific situation. Without such approval, Efforia strongly encourages you not to join the study or use the associated products and services outside the study.
| Who | Why they should not join |
|---|---|
| Pregnant, thinking of becoming pregnant, or breastfeeding | Extra caution is advised with new wellness interventions; discuss with your clinician first. |
| Individuals with seizure disorders or epilepsy | Certain sensory stimuli or intensive focus could pose risks; medical clearance is advised. |
| Individuals with severe mental health conditions | Meditation or self‑monitoring may worsen symptoms without clinical oversight. |
| Individuals with very low frustration tolerance | Device setup, data variability, or training demands may cause irritation or disengagement. |
| Individuals with implanted electronic devices | Always verify compatibility and safety with a clinician. |
| Individuals without access to local medical care | Efforia cannot provide emergency care; local access is important if issues arise. |
| Individuals who are uncomfortable with digital monitoring | Real‑time data collection may increase anxiety or feel intrusive. |
Consider your Own Risk‑Benefit Comfort Level
Carefully weigh whether the potential benefits are worth the risks for you. This citizen‑science model places more responsibility on you than a traditional sponsored trial.
It is possible that not all risks and benefits are currently known. Participants have the responsibility to consult with their healthcare providers and conduct further research before enrolling in the study.
Privacy & Security Risks
We work hard to keep your data private and confidential, but no system is risk‑free. Please review Efforia’s general privacy policy: https://efforia.com/privacy-policy/
- We may contact local help if we believe you may be a danger to yourself or others.
- Regulators (such as the FDA or similar agencies) or Institutional Review Boards may review records that include your identifying information.
The Possible Benefits of Participating—Personal and Overall Findings
Efforia will share your personal outcome reports (e.g., EEG summaries and survey results) and overall group findings. These will appear at set points during the study or when available. Your results may change your interest in continuing; participation is voluntary and you may exit any time by emailing help@efforia.com.
There is a possibility that there will be no measurable benefit to you, other than seeing reports that the intervention had no measurable impact.
What to do if you have a study related injury.
Seek local medical care first, if necessary. Efforia cannot provide emergency medical care or diagnosis. After you receive any needed treatment, please contact us about any problems, side effects, or study‑related injuries. This helps us protect other participants by understanding potential risks. Contact: help@efforia.com.
Study related injury care and compensation
Efforia is not able to offer financial compensation nor to absorb the costs of medical treatment should you be injured as a result of participating in this research. Efforia makes no commitment to provide free medical care or payment for any unfavorable outcomes resulting from participation in this research.
In the case of medical emergency
In the cace of medical emergency please dial 911 immediately. Do not attempt to contact Efforia until after the emergency has passed. Access local in person medical assistance immediately. If at any time you feel like you may be a danger to yourself or others, please dial 988 for the National Suicide Prevention hotline. Help is available.
Alternatives to Participating in the Study
This is a research study. The alternative is not to participate. If this study isn’t the right fit or is too expensive, you can click the Efforia logo at the top of the page to view other studies, including lower‑cost or free options.
Your Rights as a Participant
Ethical Considerations: Efforia upholds the same high ethical standards seen in pharmaceutical and academic research, even though we host (and do not sponsor or conduct) these studies. Your participation is voluntary, and you may withdraw at any time without negative consequences. You are not giving up any legal rights by agreeing to this document.
Privacy and Confidentiality
You have a right to privacy and confidentiality. We use strong safeguards to protect your information against unauthorized access and misuse.
Right to Your Own Results
At the end of your involvement, you have the right to an explanation of the research and your results, especially if any design elements (such as placebos or controls) were used.
The Right to Leave a Study without Penalty at Any time
If you decide to withdraw from the study, you can do so at any time by visiting your Profile page, selecting “Your Protocols,” and clicking “Leave.” Upon leaving, you will be refunded for any consumable products that have not yet been shipped. For non-consumable products, a full refund will be issued upon their return in accordance with our return policy. This ensures that you can participate in the study with the assurance that your financial contributions are handled fairly and with respect for your consumer rights.
Conflict of Interest Statement
As part of our commitment to ethical conduct and transparency, we disclose the unique structure of this citizen‑science clinical study. This trial is hosted by Efforia and sponsored by you, the participants. Efforia serves solely as the platform provider and does not sponsor or influence the study outcomes.
How Efforia makes money on this protocol: Efforia takes a transaction fee on the products and services included in this protocol. Otherwise, Efforia has no financial interest in specific outcomes and no other conflicts of interest. To further reduce conflicts, we will remind you once if you do not complete enrollment. We will not remarket to you or pressure you to join.
How we Reduce Conflicts of Interest
You also play a role. Participants should not have any financial relationship with the intervention or measurement providers (e.g., employee, investor, paid promoter) and should not be an author of this protocol. Such conflicts could bias results.
Consequences of Conflict of Interest Non‑Compliance
If a conflict is not disclosed or this policy is breached, you may be suspended from the platform and payments may not be refunded.
By joining this trial, you affirm that you understand the above conflict of interest restrictions and agree to comply fully with them. Your participation is valued, and your adherence to these guidelines ensures the validity and reliability of our collective scientific efforts.
Data Protections
Collection: We collect the information you provide (e.g., questionnaires), device data from Neuphoria (EEG sessions, usage logs), and study activity (task completion, timestamps).
Use: We use your data to generate your personal reports and to create de‑identified group‑level findings.
Protection: We apply technical and administrative safeguards to protect your data. For details, see the Efforia Privacy Policy: https://efforia.com/privacy-policy/.
What you can do to improve your privacy and security
As part of participating in this study, you will receive notifications via e‑mail, SMS, or push notification when new study tasks like questionnaires and reminders are ready for you. You can adjust your communication preferences in the Efforia application at any time. If you do not want to receive notifications from this study, do not press the Accept button. You can decide not to join this study, and will not receive notifications. To ensure others don’t see these alerts, you should make sure your phone or desktop computer and your e‑mail accounts are protected by a password, pin, or other form of “access control.” You should also avoid sharing your accounts with others or sharing your account passwords. As this study is hosted in Efforia, it is governed by a set of privacy and confidentiality standards that put you, as a participant, in control. You can learn more about Your Privacy and Security rights on Efforia here: https://efforia.com/privacy-policy.
Who will have access to your data?
Efforia will have access to your study data. Certain partners may also have access when needed to deliver services (for example, the Neuphoria device/app, laboratories if applicable, or connected health devices).
What will we do with your data
We will use your data to show you your personal results and to pool de‑identified data with other participants for general outcomes. We will not use your information connected with your name or anything that identifies you without your permission.
California Experiential Research Subject’s Bill of Rights
Participants have important rights when taking part in experiential research. You can learn more about your privacy and security rights in Efforia’s Privacy Policy here: https://efforia.com/privacy-policy/. If you are located in California and would like a copy of the Experiential Research Subject’s Bill of Rights, please contact help@efforia.com.
Questions or Concerns
This study has been reviewed by the Efforia Institutional Review Board (IRB), a group of independent experts who help protect the rights, safety, and well-being of research participants. If you have questions about your rights as a participant, or would like to speak with someone outside the research team, you can contact the IRB at ethics@efforia.com
Additional questions and closing
Efforia has approved the information in this consent form and have given approval to publish this study. This does not mean Efforia has approved or endorses you being in the study. You must consider the information in this consent form and do additional research based on your own situation for yourself and decide if you want to and are appropriate for this study. If you have questions, please contact help@efforia.com. It is up to you to do additional research and talk to your physician before joining a study.