What You Need to Know to Participate

Summary Information to Help you Decide Whether to Join this Study

Study Title	Sound Stops Stress Study: Evaluating the WAVwatch Effect
Principal Investigator	Matthew Amsden
Subinvestigator(s)	Viral Patel, MD
Author(s)	Joseph Bamber, John Bamber, Linda Bamber, Matthew Amsden
Total Cost to Participant	$597 (includes everything you need to participate)
Included Products & Services	WAVwatch 2.0 – Graphite
What You’ll Do	Daily use of WAVwatch (64 minutes), complete surveys
Time Commitment	Daily use for duration of the study (30 days)
Outcome Measures	GAD-7, DASS-21, Perceived Stress Scale, NIH Toolbox Life Satisfaction
Benefits	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	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.
Privacy	Efforia uses secure systems; see privacy policy
Contact for Questions	Email: help@efforia.com Phone Number: (646) 679-2479 Or click the chat button on your screen

👍 This table above gives you the essentials. If you’d like more detail on any topic —including risks, benefits, data privacy, or withdrawal rights—please read the full consent document below.

Introduction and Summary

Welcome to the research study Sound Stops Stress Study: Evaluating the WAVwatch Effect on the Efforia platform. Your participation, including your financial contribution, makes this research possible. This study aims to explore the effects of the WAVwatch device on stress and anxiety management. You will receive all necessary products and services in a convenient bundle, allowing you to track the impact on your own life. This document will guide you in understanding the study, its purpose, and what participation involves. Remember, your involvement is voluntary, and you can withdraw at any time without penalty. Please read through this document carefully and ask any questions you may have 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 $597 cost of the WAVwatch 2.0 - Graphite 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 effectiveness of the WAVwatch 2.0 – Graphite, a wearable device that uses sound frequencies to potentially reduce stress and anxiety. By participating, you contribute to understanding whether sound frequency interventions can support mental well-being. The study uses several measures to track outcomes, including the General Anxiety Disorder (GAD-7), Depression, Anxiety, and Stress Scales (DASS-21), Perceived Stress Scale, and the NIH Toolbox® General Life Satisfaction survey. These tools help assess changes in stress, anxiety, and overall life satisfaction.

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.

If you agree to participate in this study, you will first be asked to complete enrollment, payment, and enter your personal details, shipping details, and communication preferences.

Participant Responsibilities and Tasks

As a participant in this study, you will be asked to  engage daily with the WAVwatch device for 30 days.  You will be asked to engage with the device for 64 minutes a day using a calming frequency. This consistent daily use allows you to contribute meaningful data about your stress and anxiety management.

You will be asked to follow the following steps daily:

1. Choose a Calm-Supportive Frequency: Select the Stress & Relief Program from Frequency Sets.
2. Set Your Volume: Adjust the volume to a comfortable level between 1-3 for subtle use or 4-6 for audible feedback.
3. Secure the Watch: Wear it on the non-dominant wrist, ensuring the speaker touches the skin.
4. Press Play: Start the playback during high-stress times, opting for repeat mode if extended support is needed.

It is important for you to maintain this routine daily during your most anxious periods, while also staying hydrated and limiting device use to 6-8 hours daily for optimal effectiveness and battery life.

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

• General Anxiety Disorder (GAD-7): Questions about common anxiety symptoms.
• Perceived Stress Scale: Evaluates stress levels based on recent experiences within the last week.
• Depression, Anxiety, and Stress Scales (DASS-21): Questions about your emotions and experiences over the past week.
• NIH Toolbox® General Life Satisfaction: Questions about your feelings and attitudes about your life .

You will also be asked to complete these assessments throughout the study to track your progress and outcomes.

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

Following the timeline is important to make sure the study results are reliable.

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 - Graphite. 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 research 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 involved in the study. Participation is voluntary and you may stop the study at any time by e-mailing 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 WAVwatch 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 of 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

While Efforia provides the platform for using WAVwatch 2.0, it does not offer direct medical services or emergency response capabilities. You are encouraged to maintain regular contact

with your healthcare providers to discuss any concerns related to the use of WAVwatch 2.0.

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 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, seek local medical care first if necessary. Efforia cannot provide emergency medical care. However, it's important to contact Efforia after receiving the necessary treatment to report any problems, side effects, or injuries. You can contact Efforia at the contact details 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 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

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

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

You have rights under the California Experimental Research Subject Bill of Rights. You can find more information about your rights in the Efforia 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.