Summary Information to Help you Decide Whether to Join this Study

Study Title	Effectiveness of Chilipad in Enhancing Sleep Quality & Wellbeing
Study Author	Ana Marie Schick & Brenna Calpin of Sleep Me, with support from the Efforia team.
Sponsor	This study is made possible by your payment to join.
Cost of Products, Services & Information to Participant	$1269 (with a $400 reimbursement for successful study completion).
Included Products & Services	ChiliPad® Dock Pro Bed Cooling System & Sleep Tracker
Outcome Measures	PROMIS Sleep Disturbance Scale, Well-being Survey, 36-Item Short Form Survey Instrument (SF-36)
Contact	help@efforia.com

Introduction & Summary

Welcome! We invite you to join this research study on the Efforia platform, made possible by your support. This study aims to evaluate the effectiveness of the Chilipad Dock Pro in enhancing sleep quality and overall well-being. Participation is voluntary, and you can leave the study anytime without penalty. At any time within a 45 day period, you can return the Chilipad Docker Pro for a full refund. If you complete the study and decide to keep the device, you will be reimbursed $400 to your original payment method as a token of our appreciation. Please seek answers to any questions you may have 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

This study aims to understand how the Chilipad Dock Pro Bed Cooling System impacts sleep quality and overall well-being. The study will evaluate the effectiveness of this system using various measures, including the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Scale, Well-being Survey, and the 36-Item Short Form Survey Instrument (SF-36). These measures help us understand how the Chilipad affects sleep patterns, overall health, and daily functioning.

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.

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

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 as well as overall findings. These findings will be made available at various data collection points in your experience in the study or as they are discovered by Efforia. The results and findings may impact your interest and willingness to be involved in the study. Remember that participation is voluntary and you may exit at any time with an e-mail to help@efforia.com.

Possible Benefits of Participation

Participating in this study may offer several benefits. You might experience improved sleep quality and overall well-being due to the use of the Chilipad Dock Pro. Additionally, you will gain valuable insights into your own sleep patterns and health through detailed reports. The study also contributes to broader research, potentially helping others who may benefit from the findings.

However, it is important to note that 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

Risk Analysis Report for ChiliPad® Dock Pro Bed Cooling System & Sleep Tracker

Introduction and Summary of Known Risks

The ChiliPad® Dock Pro Bed Cooling System & Sleep Tracker is designed to enhance sleep quality through temperature regulation. While the system is generally considered safe, there are several risks and side effects associated with its use. These include minor sleep disruptions during initial use as the optimal temperature is adjusted, and rare instances of equipment malfunction that may lead to leakage. The maximum tolerable exposure to these risks is not quantitatively established but is expected to be within the normal usage of the 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)

The ChiliPad® Dock Pro Bed Cooling System & Sleep Tracker is not associated with any direct Serious Adverse Events (SAEs) such as life-threatening experiences, hospitalization, disability, or congenital anomalies. However, potential indirect effects due to product malfunction, like electrical faults leading to fire hazards (though extremely rare), should be considered.

In the Case of an Adverse Event

If you experience any serious issues such as an allergic reaction or equipment malfunction that poses safety risks, seek immediate medical care by calling 911. Once any acute situations have been addressed, please contact Efforia to report the incident. This helps us track product safety and improve future designs.

Theoretical side effects	Relative incidence	Recovery
Sleep interruptions	Moderate likelihood as you get used to the sleep system - not unlike getting used to a new matress.	Subsides with use and familiarity.
Equipment leakage	Very low likelihood	Corrects after discontinuation
Frustration and irritation	Low likelihood	Subsides with use and familiarity.

Efforia's limitations in providing direct medical support

Efforia does not provide direct medical services or emergency response for adverse events related to the use of ChiliPad® Dock Pro Bed Cooling System & Sleep Tracker. Users are advised to contact healthcare professionals for immediate concerns.

Long-term Dependence

No long-term dependence has been reported with the use of ChiliPad® Dock Pro Bed Cooling System & Sleep Tracker. Users can stop using the device at any time without adverse health consequences.

Legality for Use

The ChiliPad® Dock Pro Bed Cooling System & Sleep Tracker is not regulated by major sports associations or corporate workplace regulations. Its use is legal and does not interfere with anti-doping regulations or employment conditions.

This report provides a comprehensive overview of the potential risks associated with the ChiliPad® Dock Pro Bed Cooling System & Sleep Tracker, aiming to facilitate informed decision-making for prospective users and regulatory bodies.

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 agencies, 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 any problems, side effects, or study-related injuries, seek local medical care first if necessary. Efforia cannot provide emergency medical care or diagnosis. However, it is important to contact Efforia after receiving any necessary treatment 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. You may click on the Efforia logo in the upper portion of the page and 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 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 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

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 a participant fail to disclose such a conflict of interest or if a breach of this policy is discovered, the participant 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

Describe how data will be collected, used, and protected, ensuring 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, 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.

California Experiential Research Subject’s Bill of Rights

Participants in this study have rights that are protected under the California Experiential Research Subject’s Bill of Rights. For more information, please refer to the Efforia privacy policy available here: https://efforia.com/privacy-policy.