Study Title	30-Day MoonBrew Sleep & Stress Study
Study Author	Andrew Case, Alejandro Facundo
Sponsor	This study is made possible by your payment to join.
Cost of Products, Services & Information to Participant	$48
Included Products & Services	MoonBrew – 30 Servings
Outcome Measures	PROMIS Sleep Disturbance Scale, NIH Toolbox® Item Bank v3.0 – Perceived Stress (Ages 18+) – Fixed Form Survey
Contact	help@efforia.com

Introduction & Summary

Welcome to the 30-Day MoonBrew Sleep & Stress Study on the Efforia platform, made possible by your support through participation and financial contribution. This document provides key information to help you understand whether you want to participate in this research study. The purpose of this study is to explore the effects of MoonBrew on sleep quality and stress levels. Your participation is voluntary, and you may leave the study at any time without penalty. Please seek answers to any unresolved questions before proceeding.

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

The purpose of this study is to explore how MoonBrew, a nightly beverage, affects sleep quality and stress levels over a 30-day period. The study aims to gather scientific data that can contribute to broader knowledge in sleep and stress management. MoonBrew is a drink designed to help improve sleep quality. PROMIS Sleep Disturbance Scale and the NIH Toolbox® Item Bank v3.0 – Perceived Stress (Ages 18+) – Fixed Form Survey are tools that will be used to measure your sleep quality and stress levels, respectively.

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.

The Risks, Discomforts & Benefits of Being in this Study

There are some unique risks, discomforts, and potential benefits of being in this study that you should understand.

Consider your Own Risk-Benefit Comfort Level

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.

Personal and Overall Findings

Efforia will provide you with both personal outcomes as well as overall findings. These findings will be made available at various data collection points in your experience in the study or as they are discovered by Efforia. The results and findings may impact your interest and willingness to be involved in the study. Remember that participation is voluntary and you may exit at any time with an email to help@efforia.com.

Possible Benefits of Participation

Possible benefits of participation include improved sleep quality and reduced stress levels. You may also gain personal insights into your own sleep and stress patterns through the assessments. The study contributes to broader scientific knowledge that could benefit others in the future. However, there is a possibility that there will be no measurable benefit to you, other than seeing reports that the intervention or treatment had no measurable impact.

Possible Serious Adverse Events & Side Effects

MoonBrew – 30 Servings: Interventional New Drug Application Risk Assessment

Summary of Known Risks and Side Effects

The following is a summary of known risks. However, research is limited, and there may be risks not covered by this document, risks that are currently unknown or unforeseen. Please consider these risks carefully, do your own research, and talk to a professional who knows you well and has expertise in this area, like your personal physician.

MoonBrew, a complementary treatment aimed at improving sleep and reducing stress, involves a number of herbal and natural ingredients. Known side effects and risks associated with these ingredients include allergic reactions, gastrointestinal issues, sedation, medication interactions, hormonal effects, liver effects, sleep disturbances, blood pressure changes, and immune system effects. Most side effects observed in studies or reported anecdotally are mild and transient. However, some may require medical intervention.

In the Case of an Adverse Event

If you experience any severe symptoms such as difficulty breathing, severe rash, or significant gastrointestinal distress, seek immediate medical help by calling 911. After addressing any acute issues, please inform Efforia about the adverse event to contribute to ongoing safety monitoring.

Table of Adverse Effects and Risks

Theoretical side effects	Relative incidence	Recovery
Allergic Reactions (rash, itching, swelling, dizziness, difficulty breathing)	Low	Typically resolves after discontinuation
Gastrointestinal Discomfort (diarrhea, nausea, stomach cramps)	Moderate	Typically resolves after discontinuation
Sedation and Drowsiness	Moderate	Typically resolves after discontinuation
Interactions with Medications	Low to Moderate	Dependent on medication involved
Hormonal Effects	Low	Dependent on individual hormonal sensitivity
Gastrointestinal and Liver Effects	Low	Typically resolves after discontinuation
Sleep Disturbances (changes in sleep patterns, insomnia, vivid dreams)	Moderate	Typically resolves after discontinuation
Blood Pressure Changes	Low	Monitor and manage as per medical advice
Immune System Effects	Low	Depends on individual immune condition
Frustration and irritation	Low	Typically resolves after discontinuation

Efforia's Limitations in Providing Direct Medical Support

Efforia does not provide direct medical services. Participants are advised to maintain contact with their healthcare provider to address any medical needs or concerns that arise during the treatment.

Long-term Dependence

No long-term dependence has been reported with the use of MoonBrew. However, continuous monitoring and research are advised to better understand the potential for dependence.

Legality and Compliance

The use of MoonBrew should be disclosed to employers, and relevant sports or regulatory bodies as it contains ingredients that may appear on prohibited substance lists. Individuals should verify the legality of MoonBrew's components within their specific professional or athletic contexts.

Privacy & Security Risks

We are doing everything we can think of to keep your data private and confidential. However, there is no such thing as no risk. Potential participants should review the Efforia general privacy policy, which is available here: https://efforia.com/privacy-policy/

There may be certain limits to the rights of your privacy:

• We may reach out to local help if we have reason to believe you may be a harm to yourself and/or others.
• Regulators, like the FDA or a similar agency, or Institutional Review Boards may review records that have your identifying information.

What to do if you have a study related injury

If you have a study-related injury, you should seek local medical care first if necessary. Efforia cannot provide emergency medical care or diagnosis. However, it is important to contact Efforia if you experience any problems, have any side effects, or have any study-related injury after you've received any necessary treatment. We want to make sure others are aware of potential risks.

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 case of a 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

Since this study is for research only, the only other choice would be not to be in the study. If this study does not seem quite right, or is too expensive for your specific purposes, Efforia is dedicated to making other studies available. You may click on the Efforia logo in the upper portion of the page and find a different study that may be more appropriate.

Your Rights as a Participant

Efforia upholds the same high ethical standards in research as seen in pharmaceutical and academic studies, despite only hosting and not sponsoring or conducting these studies. Your participation in this study is completely voluntary, and you are free to withdraw at any time without any adverse consequences. You are not giving up any rights by signing this document.

Privacy and Confidentiality

You have a right to privacy and confidentiality in this research effort. Your personal information is protected through robust measures ensuring anonymity or confidentiality. All data processing is designed to safeguard personal data against unauthorized access and misuse.

Right to Your Own Results

Participants have the right to a complete explanation of the research once their involvement concludes, particularly if the study involves any form of deception like placebos or controls.

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 in our citizen science clinical trial, it is essential to disclose the unique structure of our study. This clinical trial is hosted by Efforia, but it is uniquely sponsored by you, the participants. Efforia serves solely as the platform provider and does not sponsor or influence the study outcomes.

Efforia takes a transaction fee on all the products and services included in this protocol. Otherwise, we have no financial interest or conflicts of interest. To further reduce conflicts of interest, we will remind you once if you do not complete enrollment in this study. We will not remarket to you, nor otherwise push you to join the study.

How we Reduce Conflicts of Interest:

It is crucial that participants do not have any financial relationship with the intervention methods or measurement providers used in the trial, nor should they be employees, investors, stakeholders, or protocol authors associated with these entities. Participation under such conflicts of interest could significantly compromise the study's integrity and the validity of its results.

Consequences of Conflict of Interest Non-Compliance:

Should a participant fail to disclose such a conflict of interest or if a breach of this policy is discovered, the participant will be subject to immediate suspension from this 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

Describe how data will be collected, used, and protected, ensuring compliance with data protection laws.

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 data. There may be partners who also have access to your data (like labs and connected health devices).

What will we do with your data

We will use the data to show you your own personal results and pool your results with other participants to provide general outcomes. We will not use your information connected with your name or anything that connects the data with you without your permission.

California Experiential Research Subject’s Bill of Rights

Participants should be informed about the California Experiential Research Subject's Bill of Rights. You can find more information here: Efforia Privacy Policy.

Who to Contact for Questions or Concerns

If you have questions, concerns, or complaints about this study or to report a study-related injury, contact:

HELP@EFFORIA.COM
OR CLICK THE CHAT BUTTON ON YOUR SCREEN

If you are unable to reach anyone at the number(s) listed above and you require immediate (life-threatening) medical attention, please go to the nearest emergency room.

If you do not want to talk to the investigator or study staff, if you have concerns or complaints about the research, or to ask questions about your rights as a study subject you may contact IntegReview. IntegReview is a group of people that have reviewed this research study. The main goal of this review is to protect the rights and well-being of the human subjects participating in research studies. IntegReview’s policy indicates that all concerns/complaints are to be submitted in writing for review at a convened IRB meeting to:

Chairperson
BRANY
123 Main Street
Suite 320
NY, NY 78704
email@BRANY.com

If you are unable to provide your concerns/complaints in writing or if this is an emergency situation regarding subject safety, contact our office at:

555-326-3001
or toll free at 1-800-123-4567
between 8 a.m. and 5 p.m. Eastern Standard Time

Additional questions and closing

Efforia and BRANY have approved the information in this consent form and has given approval to public this study. This does not mean Efforia or BRANY have approved your being in the study. You must consider the information in this consent form for yourself and decide if you want to be in 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.