Summary Information to Help you Decide Whether to Join this Study

Study Title	Sleep Quality Enhancement Protocol
Study Author	Matthew Amsden, Ivan Fedkiv
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
Outcome Measures	PROMIS Sleep Disturbance Scale
Contact	help@efforia.com

Introduction & Summary

Welcome to the Efforia platform, where we invite you to join our Sleep Quality Enhancement Protocol. Your participation in this study is voluntary and helps advance scientific knowledge while potentially benefiting your personal health. You'll decide if you want to participate after reviewing this information. Remember, you can withdraw at any time without any penalty. Be sure to ask any questions you may have before proceeding.

Purpose of the Study

This study aims to explore the effects of SleepWhale Natural Sleep Drops on sleep quality over a four-week period. By participating, you contribute to understanding how these drops may aid sleep improvement, potentially benefiting broader societal health. The study uses the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Scale to measure changes in sleep quality.

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 important to weigh the risks and benefits of participation carefully. We place 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 and overall findings throughout the study. These findings will be available at various data collection points or as they are discovered. The results may impact your interest and willingness to remain involved. Remember, participation is voluntary, and you may exit at any time with an e-mail to help@efforia.com.

Possible Benefits of Participation

By participating, you may experience improved sleep quality, gain insights into your own sleep patterns, and contribute to broader research findings that could benefit others. 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 Known Risks Summary

The SleepWhale Natural Sleep Drops are formulated to enhance sleep quality through a nightly routine. While comprehensive details on ingredients are not provided, the following summary addresses potential risks based on general knowledge of sleep aid compositions and their 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.

Maximum Dosages and Side Effects

Without specific ingredient information, citing maximum safe dosages from animal studies or human trials is not feasible. General side effects associated with sleep aids can include dizziness, headaches, prolonged drowsiness, allergic reactions, mood changes, and dependency issues. It is crucial that users start with lower dosages and adjust as necessary under medical supervision.

In the Case of an Adverse Event

If you experience any severe reactions, immediately call 911 for emergency medical help. After addressing any acute issues, please inform Efforia about the incident to help improve safety monitoring and product evaluation.

Serious Adverse Events (SAEs)

Some potential SAEs associated with sleep aids, though not specifically linked to SleepWhale Natural Sleep Drops due to lack of detailed ingredient information, may include:

Theoretical side effects	Relative incidence	Recovery
Severe allergic reactions	Very low likelihood	Corrects after discontinuation
Severe dizziness or cognitive impairment	Low likelihood	May correct after discontinuation
Dependency or withdrawal symptoms	Low to moderate likelihood	May have lasting effects without intervention
Frustration and irritation	Low likelihood	Subsides with use

Efforia's Limitations in Providing Direct Medical Support

It is important to note that while Efforia facilitates the protocol, it does not provide emergency medical services. Participants should have access to direct medical support through their healthcare provider.

Long-term Dependence Issues

Long-term use of sleep aids can lead to dependence, both psychological and physical. It is recommended that these drops be used as part of a short-term protocol unless advised otherwise by a healthcare professional.

Legality and Compliance

The use of sleep aids such as SleepWhale Natural Sleep Drops may be subject to review by institutions like the World Anti-Doping Association, National Collegiate Athletic Association, and corporate workplaces. Participants should verify the acceptability of using such products within their specific organizations to avoid potential conflicts or violations of policies.

As always, keep all medication and supplements out of reach of children and do not share with others for whom it is not prescribed.

Privacy & Security Risks

We are doing everything we can 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 agencies, 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 any problems, side effects, or 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 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

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

You 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

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. And 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

To access the California Experiential Research Subject Bill of Rights, please review our privacy policy at the following link: 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.