Summary Information to Help you Decide Whether to Join this Study

Study Title	Sleep Quality Enhancement Protocol
Study Author	Sam Bradley, Matthew Amsden
Sponsor	This study is made possible by your payment to join.
Cost of Products, Services & Information to Participant	$0
Included Products & Services	Sleepwhale Natural Sleep Drops (Extra Strength)
Outcome Measures	36-Item Short Form Survey Instrument (SF-36), PROMIS® Item Bank v1.0 – Sleep-Related Impairment – Short Form 8a,
Contact	help@efforia.com

Introduction & Summary

Welcome to the Efforia platform! We invite you to participate in our research study made possible by your interest and support. This study aims to enhance sleep quality with the help of Sleepwhale Natural Sleep Drops. You’ll find information here to help you make an informed decision about participating. Remember, joining is voluntary, and you can withdraw at any time without penalty. If you have questions, feel free to reach out to us.

Purpose of the Study

This study seeks to examine the effects of Sleepwhale Natural Sleep Drops on enhancing sleep quality over 30 days. The aim is to contribute to broader scientific knowledge about sleep improvement methods and understand potential societal benefits. Participants will use Sleepwhale Natural Sleep Drops, known for their calming properties, each night. The study will employ surveys like the 36-Item Short Form Survey Instrument (SF-36) and the PROMIS® Item Bank v1.0 – Sleep-Related Impairment – Short Form 8a to measure outcomes.

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

We encourage you to thoroughly weigh the risks and benefits of participation. We are placing more responsibility on you to make the right choice than in a traditionally 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.

Personal and Overall Findings

Efforia will provide you with both personal outcomes as well as overall findings throughout the study. These findings may impact your interest and willingness to continue participating. Remember, your participation is voluntary and you may exit at any time with an email to help@efforia.com.

Possible Benefits of Participation

The potential benefits include improved sleep quality and gaining personal insights into your sleep patterns. 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

Risk Assessment Report for Sleepwhale Natural Sleep Drops (Extra Strength)

Introduction and Summary of Known Risks

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.

Sleepwhale Natural Sleep Drops are designed to enhance sleep quality. While the product is aimed at improving sleep, there are potential side effects, allergies, and adverse reactions associated with its use. The maximum dosages conducted in animal studies or human trials are not specified, but it is important to follow the recommended dosages provided by the manufacturer to minimize risk.

In the Case of an Adverse Event

If you experience any severe reactions or side effects while using Sleepwhale Natural Sleep Drops, seek immediate medical care by calling 911. Once any acute situations are managed, please contact Efforia at help@efforia.com to report the incident. This will help us document the event and ensure the safety of other participants.

Serious Adverse Events (SAEs)

Potential Serious Adverse Events associated with Sleepwhale Natural Sleep Drops could include, but are not limited to:

Theoretical side effects	Relative incidence	Recovery
Incidence of Cancer	Very low likelihood	Not applicable
Exacerbation or escalation to acute or chronic disease	Low likelihood	Corrects after discontinuation
Death	Very low likelihood	Not applicable
Life-threatening experience	Low likelihood	Corrects after discontinuation
Hospitalization (initial or prolonged)	Low likelihood	Corrects after discontinuation
Disability or permanent damage	Very low likelihood	Potentially permanent
Congenital anomaly/birth defect	Very low likelihood	Not applicable
Required intervention to prevent permanent impairment or damage	Low likelihood	Corrects after discontinuation
Frustration and irritation	Medium likelihood	Corrects after discontinuation

Efforia’s Limitations in Providing Direct Medical Support

Efforia does not provide direct medical care or emergency services. It is crucial to seek local medical help for any health concerns during the treatment protocol.

Long-term Dependence

There is no known risk of long-term dependence on Sleepwhale Natural Sleep Drops based on the available data. However, users are advised to follow the treatment duration as recommended in the study protocol.

Legality for Use

The legal status of Sleepwhale Natural Sleep Drops under various institutions such as the World Anti-Doping Association, National Collegiate Athletic Association, and corporate workplaces is not clearly defined in the available documentation. Participants are encouraged to verify the legality of using these sleep drops in their specific contexts to avoid potential conflicts, especially in competitive or regulated environments.

Privacy & Security Risks

We are committed to keeping 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 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 or Institutional Review boards may review records that have your identifying information.

What to do if you have a study related injury

If you experience a study-related injury, please seek local medical care first. Efforia cannot provide emergency medical care or diagnosis. However, it’s important to contact Efforia if you experience any problems, have any side effects, or have any study-related injury after receiving 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 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

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 you fail to disclose such a conflict of interest or if a breach of this policy is discovered, you 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

We 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: Efforia 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

You can find more information about your rights in the California Experiential Research Subject Bill of Rights. For more details on our privacy policy, please visit 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

(646) 679-2479

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 Univo IRB. Univo IRB is an independent committee that helps to protect the rights and welfare of research participants. If you have any questions about your rights and welfare as a research participant, or have concerns or complaints regarding this research study, please contact Univo IRB at (919) 910-7743 or via email at info@univo-group.com.

Univo IRB

4509 Creedmoor Road
Suite 403

Raleigh, NC 27612

info@univo-group.com
(919) 910-7743

Additional questions and closing

Efforia and Univo have approved the information in this consent form and have given approval to publish this study. This does not mean Efforia or Univo 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.