Summary Information to Help you Decide Whether to Join this Study

Study Title	Twitter Detox for Improved Sleep Quality
Study Author	Ilya Pantsyr
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	$0
Included Products & Services	Withings Sleep Mat
Outcome Measures	General Anxiety Disorder (GAD-7), PROMIS Sleep Disturbance Scale
Contact	help@efforia.com

Introduction & Summary

Welcome to the Efforia platform! Thank you for considering participating in our research study. Efforia is a registered Delaware B Corporation, meaning we consider the public good in addition to financial considerations.

The Twitter Detox for Improved Sleep Quality study aims to explore whether abstaining from Twitter for 24 days can improve your sleep quality and reduce anxiety. Your participation is voluntary and you may leave the study at any time without penalty. If you decide to leave, you can still use the products and services you've received, or you may be eligible for a partial or full refund by contacting us at help@efforia.com.

We encourage you to ask any unresolved questions by reaching out to Efforia, doing your own research, and consulting your healthcare provider before deciding to participate.

Purpose of the Study

The purpose of this study is to investigate whether taking a break from Twitter can improve sleep quality and reduce anxiety. We will use the General Anxiety Disorder (GAD-7) questionnaire to measure anxiety levels and the PROMIS Sleep Disturbance Scale to assess sleep quality.

The Withings Sleep Mat will be provided to monitor your sleep patterns. These tools will help us gather accurate data on how a Twitter detox may affect your overall well-being.

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

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 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, participation is voluntary and you may exit at any time by emailing 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.

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

Introduction and Summary of Known Risks

The Withings Sleep Mat, utilized in conjunction with the Twitter Detox for Improved Sleep Quality challenge, is designed to monitor sleep patterns and contribute to the reduction of digital stress. While the product primarily focuses on tracking sleep quality and providing insights for improvement, it is crucial to discuss the potential risks associated with its use.

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 or unexpected symptoms while using the Withings Sleep Mat or during the Twitter Detox challenge, it is essential to seek immediate medical attention by dialing 911. Once any acute situations have been addressed, please inform Efforia about the incident to help improve safety and effectiveness of the intervention.

Serious Adverse Events (SAEs)

While the likelihood of experiencing Serious Adverse Events from the Withings Sleep Mat or the associated detox protocol is low, potential SAEs could theoretically include allergic reactions to the materials used in the mat, or severe psychological stress from digital detoxification.

Theoretical Side Effects	Relative Incidence	Recovery
Allergic reactions to mat materials	Very low likelihood	Corrects after discontinuation
Severe psychological stress	Low likelihood	Corrects after discontinuation
Frustration and irritation	Moderate likelihood	Subsides with use

Common Risks and Side Effects

Common risks associated with the use of the Withings Sleep Mat and participation in the Twitter Detox challenge may include:

• Skin irritation: Contact with the mat's surface could cause skin irritation in sensitive individuals. This is generally mild and subsides after discontinuation of use.
• Mood changes and frustration: Initial frustration or mood changes may occur due to reduced social media interaction. These feelings typically subside as the user adjusts to the detox process.
• Sleep disturbances: Changes in sleep patterns might be observed initially, which usually improve as the body adapts to the new routine.

Efforia's Limitations in Providing Direct Medical Support

Efforia does not provide direct medical support or emergency services. Participants are advised to contact their healthcare provider or local emergency services in the event of any serious health concerns.

Long-term Dependence

No long-term dependence has been associated with the use of the Withings Sleep Mat or the Twitter Detox protocol. Participants are encouraged to continue practicing good sleep hygiene and balanced digital habits post-challenge to maintain benefits.

Legality for Use

The use of the Withings Sleep Mat and participation in the Twitter Detox challenge is generally permissible under most institutional guidelines, including those set by the World Anti-Doping Association, National Collegiate Athletic Association, and typical corporate workplace policies. However, participants are advised to review their specific organizational policies to ensure compliance.

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.

Based on the risks informed consent, scientific evidence indicates that excessive social media use, particularly Twitter, can negatively impact sleep quality and elevate anxiety levels. The medical consensus supports digital detox as a beneficial intervention for improving mental health and sleep. Social media buzz frequently highlights the advantages of taking breaks from platforms, and the general population increasingly believes in the benefits of such detoxes. However, risks include potential withdrawal symptoms and the need for strong self-discipline. Here is a table identifying the kinds of people who should avoid being part of this trial:

Category of Individual	Contraindications	Reason
Individuals with Severe Anxiety Disorders	High levels of anxiety	Withdrawal from social media may exacerbate anxiety symptoms due to sudden lifestyle change.
Individuals with Severe Depression	Severe depression	Social isolation from reducing social media use could worsen depressive symptoms.
Individuals with Poor Self-Discipline	Difficulty in maintaining self-control	May struggle to adhere to the digital detox protocol, leading to non-compliance and increased stress.
Individuals with Insomnia	Severe sleep disturbances	Withdrawal symptoms and anxiety may further disrupt sleep patterns.
Individuals Dependent on Social Media for Work	Professional dependency	May face significant professional challenges and stress if unable to participate fully in work-related social media activities.
Individuals with a History of Substance Abuse	Past substance abuse issues	Risk of replacing social media use with another addictive behavior.
Adolescents Below the Age of Consent	Not eligible under the study protocol	Ethical and legal considerations, as they cannot provide informed consent independently.
Individuals with Lack of Support System	No supportive environment	May require additional emotional and psychological support during detox, which may not be available.
Individuals with Pre-existing Mental Health Conditions	Various mental health issues	Risk of aggravating existing mental health conditions due to sudden withdrawal and potential isolation.

This table should help clarify which individuals should avoid, or seriously consider whether the study is right for them, based on the potential risks and their unique circumstances.

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, it is important to contact Efforia if you experience any problems, have any side effects, or have any study-related injury after you've received 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 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.

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

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 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 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 in 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 in California have additional rights under the California Experiential Research Subject’s Bill of Rights. For more information, please review the Efforia privacy policy at 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 Univo 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.