What You Need to Know to Participate

Summary Information to Help you Decide Whether to Join this Study

Study Title Study Investigator           Study Sub-Investigator	Evaluating the WAVwatch 2.0 for Better Sleep Matthew Amsden Viral Patel, MD
Study Author	Joseph Bamber, John Bamber, Linda Bamber, Matthew Amsden
Study Hosted By Study Investigator Contact	Efforia Email: help@efforia.com Phone Number: (646) 679-2479

Introduction and Summary

Welcome! We invite you to join this research study on the Efforia platform, made possible by your support. This study explores the use of WAVwatch 2.0 to improve sleep quality. Your participation and financial contribution help make this possible.

The purpose of this document is to help you understand the study and decide whether to participate. Your participation is completely voluntary, and you can leave the study at any time without penalty. Before you make a decision, feel free to ask any questions by contacting us at help@efforia.com.

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 $597 cost of the WAVwatch 2.0 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

This study is being conducted to evaluate the effect of the WAVwatch 2.0 device on sleep quality. The WAVwatch 2.0 is a wearable device that uses frequency therapy (sound frequencies) to potentially improve sleep. The aim is to assess how this device impacts sleep disturbances and fatigue using well-established measures like the Neuro-QOL Item Bank v1.0 – Fatigue – Short Form, PROMIS Item Bank v.1.0 – Sleep-Related Impairment Survey, and the PROMIS Sleep Disturbance Scale. The number of participants in this study will be determined by the number of people willing to sign up.

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 WAVwatch 2.0 study, you will be asked to participate in a 30-day study designed to explore the impact of frequency therapy on sleep improvement. The primary task involves playing the Sleep folder frequencies on the WAVwatch 2.0 device every night at bedtime. This consistent nightly activity is an important part of the study.

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.
• Neuro-QOL Fatigue Short Form: Questions about your level of fatigue in the last 7 days.
• PROMIS Sleep-Related Impairment Survey: Questions about how sleep impacts your daily life. 

You will also be asked to complete these assessments weekly to monitor progress and effectiveness.

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.

It is important that you follow the schedule to make sure the study results are reliable. Consistent participation and completing all assessments on time is important to see how well the WAVwatch 2.0 works. 

Will There be Any Costs?

You will be responsible for certain costs related to your participation in this study, such as the $597 cost of the WAVwatch 2.0. If you have any questions about the costs associated with this study, please contact Efforia.

Will I be Paid for Participating?  

You will not be paid for participating in this 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.

Benefits of Being in the Study

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.

Risks Related to Study Participation

It is your responsibility to weigh the risks and benefits and decide if you should participate. You are encouraged to consult with your healthcare providers and conduct further research before enrolling in the study.

Known Risks

It is expected that the study and study device will pose no more than minimal risk to you.  Side effects that are known to be associated with WAVwatch 2.0 include tingling or warmth during use and allergic reaction to its plastic or metals.  You should not wear the device more than 8 hours per day.

Possible Risks

The following risks are theoretically possible but have not been observed with any frequency: Gastrointestinal upset, skin and hair reactions, frustration with operating the device and sound induced epileptic seizure.

For your safety, you should not participate if you have any the following conditions: Sleep disorders, audio sensitivities, chronic gastrointestinal problems, skin allergies or conditions, workplace restrictions on wearables, anxiety disorder or are pregnant/nursing.

Serious Adverse Reactions

If you experience any severe or concerning symptoms while using WAVwatch 2.0, please seek immediate medical attention by dialing 911. After receiving needed care, please contact Efforia using the information on the first page of this document to report the incident. This will help us track the safety and effectiveness of the treatment product and support ongoing research efforts.

Efforia's limitations in providing direct medical support

Efforia does not provide emergency medical services or personalized medical advice. You are encouraged to maintain contact with your personal healthcare providers throughout the study for ongoing health issues or in the event of side effects.

Long-term Dependence Issues

There are no known long-term dependence issues associated with the WAVwatch 2.0 according to the available data. Additional monitoring and further studies are needed to conclusively determine the risk of dependency.

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: https://efforia.com/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 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 the WAVwatch 2.0 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, a full refund will be issued upon the return of the product 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: 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.

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

Learn more about your rights as a research participant by reviewing the California Experimental Research Subject’s Bill of Rights. You can also view the Efforia privacy policy here.

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 IRB 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.