Important Information
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 to our research study on the “Efforia” platform. Thank you for considering joining as your support makes this possible. Efforia is a registered Delaware B Corporation, which means we consider public good in our decisions, not just financial benefits.
This document is to help you understand why you might want to join this study. The purpose is to guide you in making an informed decision about participating. Remember, your participation is voluntary, and you can leave the study at any time without penalty. If you choose to stop, you can continue using any products or services you’ve purchased, or you might qualify for a refund by contacting Efforia via email.
We encourage you to ask questions or seek advice from trusted sources and health professionals before deciding to join.
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
The purpose of this study is to explore new methods for tracking sleep patterns and their effects on overall well-being. Using the Withings Sleep Mat, a device placed under your mattress, we will collect data on your sleep cycles, duration, and quality. This information will contribute to scientific knowledge on sleep health and may offer insights into improving personal sleep habits.
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 you have completed enrollment, payment, and entered your personal details, shipping details, and communication preferences, you will follow a structured schedule of activities. These activities will occur at regular intervals and include treatment sessions with subsequent measurements to assess progress and outcomes.
The schedule is designed to ensure consistent and reliable data collection. Each activity is planned with precise timing, and regular assessments will monitor your response to the treatment, which is crucial for evaluating the intervention’s efficacy.
Adhering to the timeline is imperative, as deviations could impact the study’s findings. Compliance ensures valid research results that contribute to understanding and potentially improving the treatment being studied.
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
Thoroughly weigh the risks and benefits of participation. We are placing 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 as well as overall findings. These findings will be available at various data collection points or as discovered by Efforia. The results may impact your interest and willingness to remain in the study. Remember, participation is voluntary, and you may exit at any time by emailing help@efforia.com.
Possible Benefits of Participation
By participating, you may gain insights into your sleep patterns and overall well-being. You can use this information to make informed personal health decisions. Additionally, your participation helps advance broader research findings, potentially benefiting others. 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
Interventional New Drug Application for Withings Sleep Mat
Introduction and Summary of Known Risks
The Withings Sleep Mat is designed to monitor sleep patterns, providing users with insights into their sleep quality, duration, and disruptions. As a non-pharmacological intervention, the device primarily poses risks associated with its use in the sleeping environment and data interpretation.
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.
In the Case of an Adverse Event
If you experience any adverse event related to the use of the Withings Sleep Mat, such as an allergic reaction, electrical malfunction, or any unusual physical or psychological response, it is crucial to seek immediate medical care by calling 911. After addressing any acute situations, please contact Efforia to report the incident. This will help in further investigation and improvement of the product safety profile.
Known Risks, Side Effects, Allergies, and Adverse Reactions
While the Withings Sleep Mat is generally considered safe, potential risks include:
- Electrical Hazards: Though rare, malfunction of electrical components could pose a risk. This device should be examined regularly for any signs of wear or damage.
- Allergic Reactions: Individuals with sensitivities to materials used in the mat, such as plastics or textiles, may experience allergic reactions.
- Data Misinterpretation: Relying solely on device data without professional medical advice might lead to inappropriate self-diagnosis or management of sleep disorders.
Serious Adverse Events (SAEs)
There are no known Serious Adverse Events directly associated with the Withings Sleep Mat as it is a non-invasive monitoring device. However, potential indirect effects could arise from long-term data misinterpretation or ignoring serious underlying health conditions suggested by the data collected.
Efforia’s limitations in providing direct medical support
Efforia does not offer direct medical interventions or emergency response services. Users are advised to consult healthcare professionals for any medical concerns.
| Theoretical side effects | Relative incidence | Recovery |
|---|---|---|
| Frustration and irritation | Low | Subsides with continued use |
| Allergic reaction to materials | Very low | Resolves upon discontinuation |
| Electrical hazard | Extremely low | Immediate upon discontinuation |
| Data misinterpretation | Moderate | Resolves with professional guidance |
Long-term Dependence Issues
No long-term dependence has been identified with the use of the Withings Sleep Mat, as it is non-pharmacological and does not induce physiological dependency.
Legality for Use
The Withings Sleep Mat is legal to use under the regulations of most health monitoring devices. However, it is not regulated by the World Anti-Doping Association, National Collegiate Athletic Association, or general Corporate Workplaces as it does not enhance performance but merely monitors sleep. Users are encouraged to disclose the use of such devices if required by any specific regulations or job policies.
Inappropriate Participants Inclusion/Exclusion
Under the Efforia minimal risk protocol, within which this study is reviewed for safety and human subjects ethics, all individuals over the age of consent are eligible, however, it is the responsibility of participants to determine if their unique circumstances make participation inappropriate.
Here is a table identifying the kinds of people who should avoid being part of this trial based on risks informed consent, intervention, and outcome measures:
| Category of Individual | Contraindications | Reason |
|---|---|---|
| Pregnant or breastfeeding women | Unknown effects on fetal and neonatal development | The intervention may pose risks to unborn or nursing infants |
| Individuals with severe allergies | Potential for allergic reactions to intervention components | Risk of anaphylactic or severe allergic reactions could be life-threatening |
| Individuals with chronic illnesses | Possible exacerbation of existing medical conditions | The intervention may interact with medications or worsen health conditions |
| Individuals taking contraindicated medications | Possible drug interactions leading to adverse effects | The intervention might interact negatively with certain medications |
| Individuals with mental health disorders | Potential for exacerbation of symptoms or mental health crises | The intervention may affect mental stability or interact with psychiatric medications |
| Immunocompromised individuals | Increased susceptibility to infections or complications | The intervention may reduce immune function or interact adversely with treatments |
| Individuals with a history of substance abuse | Risk of dependency or misuse of the intervention | The intervention may have addictive properties or be misused |
Participants should carefully evaluate their personal health circumstances and consult with healthcare professionals before enrolling in the study to ensure their safety and well-being.
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: 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 agencies, or Institutional Review Boards may review records that have your identifying information.
What to do if you have a study related injury
It is crucial to seek local medical care first, if necessary. Efforia cannot provide emergency medical care or diagnosis. However, please contact Efforia if you experience any problems, side effects, or study-related injuries after receiving necessary treatment. We want to ensure 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 too expensive for your specific purposes, Efforia is dedicated to making other studies available. Click on the Efforia logo in the upper portion of the page to 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 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.
Efforia may remove you from the study if you have violated 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 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
Your data will be collected, used, and protected in compliance with data protection laws. You own your data, and it 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 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: https://efforia.com/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, such as 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.
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; and
- 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 under the California Experiential Research Subject Bill of Rights. More information is available in 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.
Univo IRB
4509 Creedmoor Road Suite 403
Raleigh, NC 27612
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 BRANY 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.