Summary Information to Help you Decide Whether to Join this Study

Study Title	Sleep Improvement with Sontrava Tea
Study Author	Efforia Research Team
Sponsor	This study is made possible by your payment to join.
Cost of Products, Services & Information to Participant	$0
Included Products & Services	Strava App
Outcome Measures	Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), Oura Activity
Contact	help@efforia.com

Introduction & Summary

Welcome to the Sleep Improvement with Sontrava Tea study on the Efforia platform! By joining this study, you are helping us understand how Sontrava tea might improve sleep quality and overall well-being. Your participation is completely voluntary, and you can leave the study at any time without any penalty. If you have any questions, feel free to reach out to us at help@efforia.com or use the online chat.

Purpose of the Study

The purpose of this study is to see if drinking Sontrava tea 30 minutes before bedtime can improve your sleep quality and overall well-being. We aim to gather data to understand the benefits better and possibly help others improve their sleep and mental health.

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

Once you have completed enrollment, entered your personal details, and set your communication preferences, here’s what’s involved:

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 and overall findings. These findings will be made available at various data collection points during your participation 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 e-mail to help@efforia.com.

Possible Benefits of Participation

By participating in this study, you might experience improved sleep quality and duration, positively impacting your mental and physical health. Additionally, you will be contributing to scientific knowledge that could help others improve their sleep and well-being. 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

Introduction and Summary of Known Risks

The Sontrava Tea, used in the Sleep Improvement Challenge, is aimed at enhancing sleep quality through its calming effects. While the primary ingredients of Sontrava Tea are not explicitly detailed, typical calming teas often include herbs such as chamomile, lavender, or valerian root, which are generally recognized as safe by various health standards. However, individual responses can vary, and some may experience adverse reactions.

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.

In the Case of an Adverse Event

If you experience any severe reaction after consuming Sontrava Tea, such as difficulty breathing, severe rash, or anaphylaxis, seek immediate medical attention by calling 911. After addressing any acute situations, please contact Efforia to report the incident. This will help us to monitor the product's safety and make necessary adjustments.

Known Risks, Side Effects, Allergies, and Adverse Reactions

• Gastrointestinal Symptoms: Mild discomfort such as nausea or indigestion may occur. These symptoms are generally temporary and often subside as your body adjusts to the tea.
• Allergic Reactions: Some individuals may be allergic to specific herbs in the tea. Symptoms could range from mild skin rashes to severe reactions like anaphylaxis.
• Headaches and Dizziness: Occasionally reported, these symptoms are typically mild and resolve without intervention after discontinuation of the tea.
• Mood Changes: While the tea aims to be calming, some individuals might experience mood swings or heightened emotional sensitivity.
• Sleep Disturbances: Although designed to improve sleep, paradoxical reactions like insomnia may occur in a very low number of cases.

Serious Adverse Events (SAEs)

While not commonly associated with herbal teas, potential SAEs cannot be completely ruled out without comprehensive studies. These events might include severe allergic reactions, significant gastrointestinal problems leading to dehydration, or prolonged mood disturbances impacting daily functioning.

Table of Serious Adverse Events (SAEs)

Theoretical side effects	Relative incidence	Recovery
Severe allergic reactions	Very low likelihood	Corrects after discontinuation, may require medical intervention
Significant gastrointestinal issues	Low likelihood	Subsides with discontinuation
Prolonged mood disturbances	Very low likelihood	May persist, requires medical evaluation

Efforia's Limitations in Providing Direct Medical Support

Efforia does not provide direct medical interventions. Participants experiencing severe side effects should contact healthcare providers for immediate assistance.

Long-Term Dependence

There is no known risk of dependence associated with Sontrava Tea based on its typical herbal composition; however, psychological dependence on herbal remedies for sleep could potentially develop.

Legality and Acceptance

Herbal teas like Sontrava are generally accepted by institutions such as the World Anti-Doping Association, the National Collegiate Athletic Association, and in most corporate workplaces, considering they do not contain prohibited substances. However, participants should verify individual components against specific lists or regulations relevant to their situations.

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: Efforia Privacy Policy

There may be very 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 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, 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 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

Ethical Considerations

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

Participants have a role in reducing conflicts of interest as well. 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

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: Efforia Privacy Policy.

Who will have access to your data?

Efforia will have access to your data. There may also be partners who have access to your data, such as 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

Tell participants about the California Experiential Research Subject Bill of Rights. Give participants a link to the 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 given approval to publish 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.