Study Title	Chilipad Sleep Optimization Study
Study Author	Ana Marie Schick, Brenna Calpin
Principal Investigator / Subinvestigator(s)	Principal Investigator: Viral Patel, MD
Sponsor	This study is made possible by your payment to join.
Included Products & Services	Chilipad Dock Pro Bed Cooling System Bundle
Cost of Products, Services & Information to Participant	Various pricing depending on size purchased. You may have already made the purchase that qualifies you for this study.
What You’ll Do	Follow the directions to sequentially use
Tim Commitment	Some setup every ten days that should be fairly easy after an initial implementation. Then largely passive. Some slightly more than weekly questionnaires.
Risks	Very minimal. Maybe some initial sleep disruption as you figure out the right temperatures for you.
Outcome Measures	PROMIS Sleep Disturbance Scale, Well-being Survey, 36-Item Short Form Survey Instrument (SF-36),
Benefits	Knowledge on what sleep settings work best for you. Knowledge about whether the Sleepme system helps you with sleep.
Contact	help@efforia.com

👍 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 & Summary

Welcome! We invite you to join the “Chilipad Sleep Optimization Study” on Efforia, a platform made possible by your participation and financial contribution. This study aims to explore sleep optimization through innovative technology. Participation is entirely voluntary, and you may withdraw at any time without penalty. It is crucial to understand the study’s purpose and ask any questions before deciding to participate.

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 “Chilipad Sleep Optimization Study” is designed to assess the effects of the Chilipad Dock Pro Bed Cooling System on sleep quality. With the Sleep Tracker and Sleepme app, the study aims to provide evidence on how temperature regulation can enhance sleep. This research could contribute to scientific knowledge about sleep optimization and benefit society by offering new methods to improve sleep quality.

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, shipping details, and communication preferences, you will engage in a structured 30-day study.

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 are placing more responsibility on you to make the right choice than in a traditionally sponsored trial. It is possible that not all risks and benefits are currently known. Participants have the responsibility to consult with their healthcare providers and conduct further research before enrolling in the study.

Personal and Overall Findings

Efforia will provide you with both personal outcomes and overall findings. These findings will be made available at various data collection points or as they are 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 with an e-mail to help@efforia.com.

Possible Benefits of Participation

No Benefit: A key risk to all studies is that there is no benefit, and that participants receive no benefit from the proposed intervention or treatment, despite the financial payment the participant has made. At the end of the possible benefits of participation section, let the participant know there is a possibility that there will be no measurable benefit to the participant, other than seeing reports that the intervention or treatment had no measurable impact.

Possible Serious Adverse Events & Side Effects

Introduction and Summary of Known Risks

The Chilipad Dock Pro Bed Cooling System Bundle is designed to optimize sleep through temperature regulation. This document outlines potential risks associated with the use of the Chilipad Dock Pro and Sleep Tracker as per academic literature, online forums, and user testimonials.

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 severe discomfort or symptoms that concern you while using the Chilipad Dock Pro, please seek immediate medical attention by calling 911. Once any acute situation has been addressed, please contact Efforia to report the adverse event.

Risks Associated with Chilipad Dock Pro Bed Cooling System

Theoretical Side Effects	Relative Incidence	Recovery
Initial sleep interruptions	Low to moderate likelihood	Subsides with use
Leaking and wetness due to malfunction	Very low likelihood	Corrects after discontinuation
Frustration and irritation	Low likelihood	May subside with use

Some individuals may be at increased risk:
Individuals with concerns about water leakage

• Risk: Exposure to water/moisture due to potential leaking
• Impact: Product malfunction may cause leaking and wetness, triggering allergies

Individuals with sleep disorders related to changes in temperature

• Risk: Sensitivity to temperature changes
• Impact: Initial sleep interruptions could exacerbate pre-existing sleep issues

Individuals with thermal sensitivity

• Risk: Difficulty tolerating temperature shifts
• Impact: The system’s temperature range could cause discomfort or adverse reactions

Individuals who are easily frustrated by technology

• Risk: Continued adjustments of the device per study requirements may cause frustration
• Impact: This study requires several adjustments of the device over the study period

Individuals with pacemakers or medical implants sensitive to electromagnetic fields

• Risk: Potential interference with device function
• Impact: AI-driven features may produce electromagnetic fields affecting device operation

Pregnant individuals

Impact: Changes in sleep temperature and patterns could impact pregnancy without known safety data

Risk: Unknown effects on pregnancy

Efforia’s Limitations in Providing Direct Medical Support

Efforia does not provide direct medical services or emergency response. Users are advised to contact their healthcare provider or local emergency services in the case of any significant adverse reactions or health concerns.

Long-Term Dependence

There is no known risk of long-term dependence associated with the use of the Chilipad Dock Pro Bed Cooling System as it is a non-pharmacological intervention primarily focused on environmental comfort.

Legality for Use

The Chilipad Dock Pro Bed Cooling System is a consumer product and does not contain substances regulated by major agencies like the World Anti-Doping Association, National Collegiate Athletic Association, and typical corporate workplace policies. However, participants should verify with their specific institutions to ensure compliance with any specific rules or restrictions regarding the use of sleep-enhancing devices.

This document aims to provide a thorough overview of the potential risks associated with the use of the Chilipad Dock Pro Bed Cooling System Bundle. As with any product, individual experiences may vary, and it is important to use the product as directed and consult with a healthcare provider with any concerns.

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 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 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, please contact Efforia if you experience any problems, have any side effects, or have any study-related injury 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

This study is for research only, so the alternative would be not to participate. If this study doesn’t seem right for you, or is too expensive for your purposes, Efforia offers other studies. Click on the Efforia logo at the top of the page to find a different study that may suit you better.

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 or conducting 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.

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:

Participants play 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:

If a participant fails to disclose such a conflict of interest or a breach of this policy is discovered, they 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:

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, 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, like 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.

California Experiential Research Subject’s Bill of Rights:

Learn more about your rights by reviewing the Efforia privacy policy here: 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

This study has been reviewed by the Efforia Institutional Review Board (IRB), a group of independent experts who help protect the rights, safety, and well-being of research participants.

If you have questions about your rights as a participant, or would like to speak with someone outside the research team, you can contact the IRB at ethics@efforia.com

Additional questions and closing

Efforia and Efforia IRB have approved the information in this consent form and have given approval to publish this study. This does not mean Efforia or Efforia IRB 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.