Summary Information to Help you Decide Whether to Join this Study

Study Title	Kate protocol for tests
Study Author	Kate Gerbeda, Reviewer User
Principal Investigator	Matthew Amsden, CEO Efforia. Dr. Viral Patel Sub-Investigator for Adverse Events
Sponsor	This study is made possible by your payment to join.
Cost of Products, Services & Information to Participant	$1
Included Products & Services	Withings Sleep Mat
Outcome Measures
Contact	help@efforia.com

Introduction & Summary

Welcome! You are invited to join this research study on the “Efforia” platform, made possible by your support through participation and financial contribution. Efforia is a registered Delaware B Corporation, which means it considers the public good in its business decisions alongside traditional financial goals.

This research study provides key information to help you decide whether to participate. The purpose of the study is to advance scientific knowledge and societal benefits. Participation is voluntary, and you may leave the study at any time without penalty. You can continue using the products and services you’ve purchased even if you leave the study. If you prefer not to use the products, a partial or full refund may be possible depending on the study timeline by reaching out to Efforia via email.

If you have any questions, do not hesitate to contact Efforia, do your own research, or consult with a healthcare professional who knows your circumstances.

Efforia is a citizen science platform where studies are effectively sponsored by you, the participants. Unlike traditional research studies, you pay for all the supplies, services, information, and tools needed for participation in one transaction. This makes studies possible that might not be 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 comprehensive, data-driven research experience. This setup allows you to track and understand the impact on your own life via detailed outcome reports, making informed personal health decisions easier. It also advances broader research findings, benefiting others who might not afford such purchases without guaranteed results.

Efforia is committed to equitable inclusion. If the cost is too high for you, click the large Efforia logo at the top of the screen to explore other protocols. Efforia offers protocols 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 aims to evaluate the effectiveness of the Withings Sleep Mat, a device that monitors sleep patterns, in improving sleep quality. The study will contribute to scientific knowledge about sleep improvement tools and their potential benefits for individuals and society. Participants will be using the Withings Sleep Mat to track their sleep and report their experiences.

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.

Once enrolled, completed payment, and provided personal and shipping details, you will need to adhere to a specific schedule. This involves engaging in treatment activities and undergoing measurements at regular intervals. Following this timeline ensures consistent data collection and assessment, which is vital for the study’s success.

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 place more responsibility on you to make the right choice than in a traditionally sponsored trial. Since this is an experimental exercise, there may be possible unknown side effects that the authors are unaware of. Participants have the responsibility to consult with their healthcare providers and conduct further research at sources they find reputable before enrolling in the study.

Personal and Overall Findings

Efforia will provide you with both personal outcomes and overall findings. These will be shared at various data collection points or as they are discovered. Results may impact your interest and willingness to continue in the study. Remember, participation is voluntary and you may exit at any time by emailing help@efforia.com.

Possible Benefits of Participation

Participating in this study may provide you with valuable insights into your sleep patterns and the effectiveness of the Withings Sleep Mat. The data collected may also contribute to broader scientific understanding and societal benefits regarding sleep health. 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

In the Case of an Adverse Event

If you experience any adverse event while using the Withings Sleep Mat, it is critical to seek immediate medical attention by dialing 911, especially if the event is severe or life-threatening. After addressing any acute situations and when it is safe to do so, please inform Efforia about the incident. This will help us to monitor the safety and effectiveness of our product and provide better guidance to all users.

Introduction and Summary of Known Risks

The Withings Sleep Mat is generally considered safe for use. However, as with any health-related technology, there may be risks associated with its use. The most common concerns reported are minor and include discomfort due to the mat’s texture or material, and allergic reactions to the mat’s components if you have specific sensitivities. Research on the maximum dosages or exposure times and their correlation with side effects is not applicable for this non-pharmacological product.

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.

Serious Adverse Events (SAEs)

There have been no Serious Adverse Events (SAEs) directly linked to the use of the Withings Sleep Mat as of current literature and user reports. Below is a table summarizing potential theoretical side effects based on the nature of the product:

Theoretical side effects	Relative incidence	Recovery
Discomfort due to mat texture or material	Low likelihood	Subsides with use
Allergic reactions to mat components	Very low likelihood	Subsides after discontinuation
Frustration and irritation	Low likelihood	Subsides with use

Efforia’s Limitations in Providing Direct Medical Support

Efforia does not provide direct medical support or emergency services. It is important for users to have access to medical care and to consult healthcare professionals for any health-related issues or concerns that arise during the use of the Withings Sleep Mat.

Long-Term Dependence

No long-term dependence has been reported by users of the Withings Sleep Mat. It is designed for monitoring and improving sleep quality and does not induce physiological dependency.

Legality for Use

The Withings Sleep Mat is a non-pharmacological, non-invasive device and is generally permitted for use by various institutions including the World Anti-Doping Association, National Collegiate Athletic Association, and in general Corporate Workplaces. It does not contain substances or mechanisms that would typically alter performance in a way that could be considered enhancing or inhibiting according to these organizations’ regulations.

Inappropriate Participants Inclusion/Exclusion

I’m here to assist you with creating a table based on the information you provide regarding risks and interventions. Please provide the specific risks, intervention details, and any outcome measures so I can generate a comprehensive table identifying individuals who should avoid participation in the trial.

Privacy & Security Risks

We are doing everything we can think of 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: 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 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

Seek local medical care first, if necessary. Efforia cannot provide emergency medical care or diagnosis. However, it is important to contact Efforia if you experience any problems, side effects, or study-related injuries 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 is too expensive for your specific purposes, Efforia is dedicated to making other studies available. You may click on the Efforia logo at the top of the page and find a different study that may be more appropriate.

Your Rights as a Participant

Efforia upholds high ethical standards in research, similar to those in pharmaceutical and academic studies. Your participation 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.

Efforia may remove you from the study if you violate Efforia’s overall terms and conditions, privacy policy, or have a conflict of interest. Efforia may also remove you from the study in the interest of safety based on individual or community findings.

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 makes money on this protocol by taking a transaction fee on all the products and services included. 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 you do not have any financial relationship with the intervention methods or measurement providers used in the trial, nor should you 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

Your data will be collected, used, and protected in compliance with data protection laws. You own your data, which will be housed on Efforia indefinitely until you tell us to delete it by emailing help@efforia.com.

What you can do to improve your privacy and security

As part of participating in this study, you will receive notifications via email, 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 email 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: 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 (like labs and connected health devices).

What will we do with your data

We will use your data to show you your 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.

Authorization to Use and Disclose Protected Health Information

If you decide to take part in this study, the study doctor and study staff may use and share protected health information (PHI) about you to conduct the study. Protected health information may come from your medical or research records. Protected health information may include the following:

Name
Location
Dates
Phone Numbers
Email Addresses
Internet protocol (IP) address numbers

The study staff may share protected health information about you with the following authorized users to ensure the quality of the study conduct and study data:

Efforia
The Office of Human Research Protections (OHRP)
Univo Institutional Review Board
University of Portsmouth Ethics Review Board
Other regulatory agencies

Once your protected health information has been shared with authorized users, it may no longer be protected by federal privacy laws and could possibly be used or disclosed in ways other than what is listed in this section.

Your permission to use and share protected health information about you will end after you have completed the study and any after-study related activities unless you revoke your permission sooner.

You can revoke your permission to use and share protected health information about you at any time by contacting the study doctor listed on the first page of this document. If you revoke your permission, you will not be able to stay in this study. No new protected health information will be collected after your request has been received. The protected health information about you that has already been collected may still be used and given to others as described in this section.

If you decide not to sign and date this document, you will not be able to take part in the study. However, you may continue to use and consume anything you’ve purchased to be part of the study outside the study.

California Experiential Research Subject’s Bill of Rights

Participants have rights outlined in the California Experiential Research Subject Bill of Rights. You can find more information about your privacy rights by visiting the Efforia privacy policy: https://efforia.com/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 OR CLICK THE CHAT BUTTON ON YOUR SCREEN

We will immediately respond with an automated message giving you a sense of how long a more meaningful response will take based on the volume of other requests.

(646) 679-2479. If no one is available, please leave a message. We will typically respond to telephone messages in three to five business days.

If you are unable to reach anyone at the number(s) listed above and you require immediate (life-threatening) medical attention, please dial 911 in the US/Canada or 999 in the UK and/or 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

(919) 910-7743 or via email at info@univo-group.com.