Study Title	Evaluating SleepWhale Drops for Rest & Resilience
Study Investigator Study Sub-Investigator           Study Author	Matthew Amsden Viral Patel, MD Matthew Amsden, Hunter Kilburn, Weston McVicker
Study Hosted By	Efforia
Study Investigator Contact	Email: help@efforia.com Phone Number: (646) 679-2479

Introduction and Summary 

Welcome! You are invited to join this research study on the "Efforia" platform. This study is made possible by your support through participation and financial contribution. This document provides key information to help you decide whether to participate. The study is voluntary, and you can leave at any time without penalty. Feel free to ask any questions before proceeding.

Efforia is a citizen science platform where research studies are supported by you, the participants. Unlike regular research studies, you pay for all the supplies, services, information, and tools needed for participation at one time. This way, we can do studies that might not be possible 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 complete, data-driven research experience. This setup allows you to track and understand the impact that participating in the study may have on your own life through detailed reports, making it easier to make informed personal health decisions. It also helps advance research that can benefit others who might not be able to afford these products without guaranteed results.

Efforia is committed to equal participation. If the $121 cost of SleepWhale Natural Sleep Drops is too high for you, click the large Efforia logo at the top of the screen to explore other study opportunities. Efforia offers studies 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 evaluate the effect of SleepWhale Natural Sleep Drops (Extra Strength) on sleep quality, fatigue, and resilience. This study aims to provide insights into natural sleep aids' impact on sleep disturbances and overall well-being. The study will use measures such as the PROMIS Sleep Disturbance Scale, Daytime Sleepiness Perception Scale (DSPS-4), Fatigue Perception and Impact Survey, and Resilience Assessment Scale to help us understand how SleepWhale can potentially improve sleep quality and reduce fatigue.  The number of participants in the study will depend on how many sign up to volunteer.

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 via online chat.

As a participant in the SleepWhale study, you will be asked to integrate Sleep Drops into your nightly routine for 30 days. This involves administering the drops 15 minutes before bedtime, placing them under your tongue for 1–2 minutes before swallowing. You should start with 0.5mL, gradually increasing to 1mL based on your response.

When you begin the study, you will be asked to complete the following scales on the Efforia website: 

• PROMIS Sleep Disturbance Scale:  Questions about sleep-related issues such as difficulty falling asleep and restless sleep.
• Daytime Sleepiness Perception Scale: Questions about how sleepy you feel during the day.
• Fatigue Perception and Impact Survey: Questions about the impact of fatigue on your life.
• Resilience Assessment Scale: Questions about your level of resilience in different situations. 

You will also be asked to complete these assessments weekly to monitor changes and progress. It is important that you follow the schedule and dosage instructions to make sure the study results are reliable. Consistent participation and completing all assessments on time is important to see how well the Sleep Drops work.

You should avoid starting or stopping any new supplements or other products to improve sleep during the study period to ensure that any changes in sleep quality may be attributed to the study product.

Will There be Any Costs?

You will be responsible for certain costs related to your participation in this study, such as the $121 cost of SleepWhale Natural Sleep Drops (Extra Strength). If you have any questions about the costs associated with this study, please contact Efforia.

Will I be Paid for Participating?  

At the end of the study, if you have completed all the assessments in the study, you will receive a $100 SleepWhale gift card you can use for any future SleepWhale purchases. 

The Risks, Discomforts, and Benefits of Being in this Study

There are some 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. Please talk with your healthcare providers and make sure all of your questions have been answered before deciding to participate in the study.

Personal and Overall Findings

Efforia will provide you with both personal outcomes as well as overall study findings. These findings will be made available at various points during the study or as they are discovered by Efforia. The results and findings may impact your interest and willingness to stay in the study. Participation is voluntary and you may stop the study at any time by emailing help@efforia.com.

Possible Benefits of Participation

You may have some benefit from the use of SleepWhale. There may be no direct medical benefit to you for participation in this study. Your participation, however, will provide information about SleepWhale and may help other people in the future.

Possible Risks and Side Effects

In the Case of a Side Effect

If you experience any severe or unexpected symptoms, it is important to seek immediate medical care. In an emergency, dial 911 and do not delay. After the situation has been addressed, please contact Efforia using the information on the first page of this document to report the incident. This helps us track product safety and improve future guidelines.

Risks and Side Effects

The following is a summary of known risks. However, research is limited, and there may be risks that are currently not known. Please consider these risks carefully, ask any questions you might have, and talk to your primary care physician.

Side effects that are known to be associated with the ingredients in SleepWhale include drowsiness, digestive discomfort or upset.  The product should not be consumed if you are pregnant or breastfeeding and you should not operate machinery or drive after use. It should not be combined with strong sedatives.  

Other theoretical symptoms that have not been observed with any frequency include:

Theoretical side effects	Relative incidence	Recovery
Skin & Hair Reactions	Low likelihood	Symptoms lessen after stopping the product
Headaches	Moderate likelihood	Symptoms lessen with use
Fatigue: Dizziness	Moderate likelihood	Symptoms lessen with use
Mood Changes:	Low likelihood	Symptoms lessen with use
Sleep Disturbances	Low likelihood	Symptoms lessen with use
Mental Health Discomfort	Low to moderate likelihood	May persist if product is continued
Frustration and irritation	Moderate likelihood	May persist while using product

Certain Individuals May Be At Increased Risk

Below is a table identifying the kinds of people who should carefully consider whether this study is right for them. These individuals should consult with their healthcare provider to carefully consider their participation in the study, given the potential risks and contraindications.

Category of Individual	Contraindications	Reason
Individuals with known allergies to herbal or natural supplements	Known allergies to herbal or natural supplements	Risk of severe allergic reactions or interactions with existing allergies
Individuals currently taking medications that may interact with SleepWhale	Currently taking medications that may interact with SleepWhale	Potential for drug interactions leading to side effects or current medication not working as well
Individuals with Gastrointestinal Issues	Preexisting gastrointestinal conditions	Gastrointestinal symptoms may worsen existing conditions
Individuals with Existing Skin Conditions	Existing dermatological conditions	Risk of skin and hair reactions may worsen existing conditions
Individuals Prone to Headaches	History of frequent or severe headaches	Moderate likelihood of headaches could worsen their condition
Individuals with Preexisting Mental Health Conditions	Preexisting mental health disorders	Potential for mood changes or mental health discomfort to worsen existing conditions
Pregnant or Breastfeeding Individuals	Pregnancy or breastfeeding status	Lack of research on effects during pregnancy or breastfeeding, posing potential risks
Athletes and Competitive Participants Subject to anti-doping regulations	Subject to anti-doping regulations	Potential conflict with anti-doping rules and regulations
Individuals with Dependency Issues	History of dependence on sleep aids or other substances	Risk of developing dependency on SleepWhale Natural Sleep Drops
Individuals with Dizziness or Fatigue Issues	Preexisting conditions related to dizziness or fatigue	Moderate likelihood of experiencing fatigue and dizziness could impact their daily functioning

Efforia's limitations in providing direct medical support

It is important to note that Efforia does not provide direct medical support. You should maintain contact with your health care provider for ongoing health issues or in the event of side effects.

Dependencies and Long-term Use

Long-term dependence on sleep aids, including natural drops like SleepWhale, is a concern. Dependency can lead to the product not working as well over time and potential withdrawal symptoms upon stopping. Regular evaluation of the necessity and dosage is recommended.

Legality and Compliance

If you participate in sports or your employment is subject to specific substance use policies, consult with the governing bodies or your management team.

Privacy and Security Risks

Your research records will be kept confidential to the extent permitted by applicable laws and/or regulations. Efforts will be made to keep your personal information private, however, total confidentiality cannot be guaranteed.   The results of this study may also be published or presented at medical meetings, but your identity will not be disclosed. 

You should review the Efforia general privacy policy, which is available here: 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 US Food and Drug Administration (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 experience a study-related injury, please seek local medical care first, if necessary. Efforia cannot provide emergency medical care. However, it is important to contact Efforia in the case you experience any problems, have any side effects, or have any study-related injury after you've received the necessary treatment. You can contact Efforia at the contact details provided in the beginning of this consent.  

Study related injury care and compensation

Efforia does not plan 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. You will need to access local in-person medical assistance immediately.  You should contact Efforia  after the emergency has passed.  If at any time during the study you have any thoughts of hurting yourself or someone else, you can call the toll-free 24-hour National Suicide Prevention Lifeline at 1-800-273-TALK (8255) or call or text 988.

  

Alternatives to Participating in the Study

You do not have to take part in this study. The alternatives are you may use SleepWhale outside of your participation or you can choose not to participate.

Your Rights as a Participant

Your participation in this study is completely voluntary, and you are free to withdraw at any time without any consequences. You are not giving up any rights by signing this document.

Right to Your Own Results

You have the right to a complete explanation of the research once your participation has ended.

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 the study, 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 and that your purchases are handled fairly.

We will tell you of any information learned during this study that might cause you to change your mind about continuing to take part.   

Conflict of Interest Statement

As part of our commitment to ethical conduct and openness in our citizen science clinical trial, it is important to explain the unique structure of our study. This clinical trial is hosted by Efforia, but it is uniquely sponsored by you, the participants. Efforia serves 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 study. 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 important that participants do not have any financial relationship with the intervention methods or measurement providers used in the study, nor should they be employees, investors, stakeholders, or protocol authors associated with these entities. Participation under such conflicts of interest could significantly affect the study's integrity and the 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 study, you affirm that you understand the above conflict of interest restrictions and agree to follow them. Your participation is valued, and your commitment to following these guidelines helps make sure that our collective scientific efforts are accurate and reliable.

Data Protections

Efforia ensures that data will be collected, used, and protected in 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, please 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. You can learn more about Your Privacy and Security rights on Efforia here: 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.

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 Experimental Research Subject’s Bill of Rights

For more information about your rights as a research subject, you can refer to the California Experimental Research Subject’s Bill of Rights. Please visit the Efforia privacy policy: Privacy Policy.

A description of this clinical trial will be available on https://www.ClinicalTrials.gov, as required by U.S. Law.  This Web site will not include information that can identify you.  At most, the Web site will include a summary of the results. You can search this Web site at any time.

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:

Email: HELP@EFFORIA.COM
Phone Number: (646) 679-2479
OR CLICK THE CHAT BUTTON ON YOUR SCREEN

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

An institutional review board (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.  

Participant Consent

Efforia and Univo have reviewed the information in this consent form. 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.

By signing below, I agree that:

• I have read this consent document and understand the purpose, procedures, and risks of the research described in this study.
• I have had the chance to ask questions and they have been answered to my satisfaction.
• I understand that taking part in this study is voluntary.
• I agree to participate in this study as explained in this Informed Consent Form. 
• I give permission to use and share my data as described in this document.  
• I may choose not to be in the study or to leave the study at any time by following the instructions provided above. I will not be penalized or lose any benefits to which I am otherwise entitled.
• I will receive a copy of this document after I have signed and dated it.