Terms of Service

You are being invited to participate in a research study. Your participation is voluntary and you should only participate if you completely understand what the study requires and what the risks of participation are. You should ask the study team any questions you have related to participating before agreeing to join the study. If you have any questions about your rights as a human research participant at any time before, during or after participation, please contact the Institutional Review Board (IRB) at (215) 898-2614 for assistance.

What is the purpose of this research study?

The purpose of this research study is to learn more about effective ways to encourage patients to use a behavioral treatment for insomnia (which involves changing the things you do before going to sleep).

How long will I be in the study? How many other people will be in the study?

The study will last three months and two weeks for you. There will be a 14-day sleep diary period, then a thirty-day treatment period, and a follow-up assessment two months later. The entire study (for all participants) will take two years. There will be 240 people in the study.

What am I being asked to do?

If you agree to join the study, you will be asked to complete the following research procedures:

• Complete questionnaires which will ask questions about your sleeping habits and health history. The questionnaires will take about 30 minutes to complete, and you will be asked to fill them out at four separate times during the study
• Modify your pre-sleep patterns to improve sleep hygiene
• Download and use a mobile application, TapToSleep, for the duration of the study
• Communicate with the study staff regularly via email and phone to track your progress

For 14 days (two weeks), you will use TapToSleep to fill out a daily morning and evening sleep diary entries to record your baseline sleep pattern. If you do not fill out the diary or use the app for a week or more, your account may be disabled and you will no longer be able to use it or continue in the study.

If you continue to remain eligible to participate in the research study after the initial 2-week pre-intervention period, you will be called by a member of the study staff, who will review the sleep diary entries with you, discuss the study in more detail, and answer any outstanding questions. At this time, you will also be evaluated for depression and may be asked questions about whether you have thought about, planned, or acted in ways that purposely resulted in physical harm to yourself. You may be referred to a mental health care provider or emergency health service. After this assessment, you may then be “randomized” into one of two behavioral research study groups. Randomization means that you are put into a group by chance (like flipping a coin, with equal chance of either treatment). A computer program will place you in one of the research groups. Neither you nor the researchers can choose the group you will be in.

For the next four weeks, you will then be asked to use the mobile application. This will include filling out a daily morning and evening sleep diary on the app (this should take less than five minutes to complete). The mobile app will also provide you with instructions on the behavioral treatment for your insomnia and will provide you with educational content related to sleep and the research study.

You will have a personalized app portal that you will log into that will allow you to track your progress towards meeting your goals. Please do not share the information on your portal (including personal data and study-provided educational content) with anyone except your doctor.

Additionally, the staff will contact you regularly via phone and e-mail during your participation in the study in order to monitor your participation and progress, help answer any concerns or questions, and screen for any potential study-related issues. Please note that email is not a secure form of communication; please do not share personal or private information with the staff via email.

What are the possible risks or discomforts?

The research study behavioral treatments involve changing your pre-sleep routine. This may cause increased anxiety or nervousness about your sleep, which may temporarily worsen your insomnia.

The main risk to you is from loss of confidentiality or private information. Several steps will be taken to protect your privacy as described in the section below labeled “How will my personal information be protected?”.

Both your Smartphone and the smartwatch use electricity. Please avoid keeping them plugged in to a charger while sleeping. You should instead charge your smartphone and smartwatch in the morning after you wake up.

Study staff will be available to discuss any concerns you may have about your participation in the study. You may contact the study staff at any time using the contact information provided to you in this document.

Please note that the research may involve risks that are currently unforeseeable.

What if new information becomes available about the study?        

During the course of this study, we may find out information that could be important to you. This includes information that, once learned, might cause you to change your mind about being in the study. We will notify you as soon as possible if such information becomes available. You will always have the right to change your mind about being in this study.

What are the possible benefits of the study?      

The study involves changes to your pre-sleep routine that may improve your insomnia. You may not get any benefit from being in this research study.

What other choices do I have if I do not participate?   

The alternative to participating is to not participate and seek other treatment options for insomnia. These include Cognitive Behavioral Therapy, which involves eight to ten out-patient visits with a psychologist. Another option is sedative-hypnotic medications, such as zolpidem (also known as Ambien). Please feel free to discuss these options with your physician.

Will I have to pay for anything?      

You and/or your health insurance may be billed for the costs of medical care during this study if these expenses would have happened even if you were not in the study, or if your insurance agrees in advance to pay. Study subjects using a personal device are responsible for their own data charges. You will be responsible for any data usage associated with the use of the TapToSleep mobile application. For example, if you have a monthly data plan, any data usage associated with the TapToSleep account will count towards your total available monthly data. Data charges incurred on study-provided equipment is covered by the research study.

What happens if I am injured from being in the study?

We will offer you the care needed to treat injuries directly resulting from taking part in this research. We may bill your insurance company or other third parties, if appropriate, for the costs of the care you get for the injury, but you may also be responsible for some of them. There are no plans for the University of Pennsylvania to pay you or give you other compensation for the injury. You do not give up your legal rights by signing this form.
If you think you have been injured as a result of taking part in this research study, tell the person in charge of the research study as soon as possible. The researcher’s name and phone number are listed in the consent form.

When is the Study over? Can I leave the Study before it ends?     

The study is expected to end after all participants have completed all visits and all the information has been collected. The planned duration for each individual is 3 months and two weeks. Your participation in the study may be terminated without your consent for the following reasons:

• The Principal Investigator (PI) feels it is best for your safety and/or health. If this is the reason for termination you will be informed of the reasons why.
• You have not followed the study instructions.
• The PI, the sponsor, or the Office of Regulatory Affairs at the University of Pennsylvania can stop the study anytime.

You have the right to drop out of the research study at any time during your participation. There is no penalty or loss of benefits to which you are otherwise entitled if you decide to do so. Withdrawal will not interfere with your future care.

If you no longer wish to be in the research study, please contact the study Research Coordinator by phone at 215-573-7293.

There are no negative consequences for leaving the study early.

Use of Study Materials 

Information about you that is collected during the study will not be given to others (unless it is required by a government agency or other legal authority). This means that no one (not your family, your doctor, your insurance company, or your employer) will have access to this information during the study.

Who may use or share my information? How will my personal information be protected?

The Principal Investigator (Nalaka Gooneratne, MD, MSc) and staff involved with the study will keep your personal information strictly confidential. Your confidentiality will be maintained by using a unique subject identification number on all records instead of your name. All paper records will be stored in a locked cabinet in a locked office. All electronic records which contain personal health information will be protected with a password and the information will be encrypted (scrambled using a special code). At any time, you may ask to see your personal information (such as name and address) and correct it if necessary.

We will do our best to make sure that the personal information obtained during the course of this research study will be kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used. The IRB at the University of Pennsylvania will have access to the study records as well.

Why is my information being used?

Your personal information will be used by the research team to contact you during the study. Your responses to questionnaires will be used to:

• Do the research
• Oversee the research
• Make sure the research was done right
• Ensure that money for your participation in the research is sent to you

Who may use and share information about me?

The following individuals may use or share your information for this research study:

• The investigator for the study and the study team
• Other authorized personnel at Penn, including offices that support research operations
• Other research personnel with access to the databases for research and/or study coordination and as otherwise approved by the IRB

Who, outside of the University of Pennsylvania School of Medicine, might receive my information?

• Those working under the direction of the investigator for the study: Advanced Medical Electronics, an outside company that is helping to develop the software. They will only be provided de-identified information (i.e., they will not be told any information that can be used to directly identify you, such as your name or address).
• The funding sponsor of this study, the National Institutes of Aging, a subset of the federal U.S. Department of Health and Human Services, may have access to data if requested.
• A Data Safety Monitoring Board, which is approved by the National Institutes of Aging and is comprised of an independent group of experts who periodically evaluate and review the study. The DSMB primarily reviews study-specific data in order to ensure participants’ safety, and the progress and effectiveness of the study.

Once your personal health information is disclosed to others outside the School of Medicine, it may no longer be covered by federal privacy protection regulations.

The Principal Investigator or study staff will inform you if there are any additions to the list above during your active participation in the trial. Any additions will be subject to University of Pennsylvania procedures developed to protect your privacy.

How will confidentiality be maintained and my privacy be protected?

We will do our best to make sure that the personal information obtained during the course of this research study will be kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used.

How long may the University of Pennsylvania School of Medicine use or disclose my personal health information?

Your authorization for use of your identifiable personal health information (i.e. information or data that can be linked directly back to you) for this specific study does not expire.

Your identifiable information will be held in the research database. However, the University of Pennsylvania School of Medicine may not re-use or disclose information collected in this study for a purpose other than this study unless:

• You have given written authorization
• The University of Pennsylvania Institutional Review Board grants permission
• As permitted by law

We may use your data in the future in its de-identified form. De-identified data is data that is obtained during a research study that has been disconnected from the participant’s identity. De-identified data cannot be traced back to a specific individual. The de-identified data will be stored and may be distributed for future research studies without additional informed consent.

Can I change my mind about giving permission for use of my information?

Yes. You may withdraw or take away your permission to use and disclose your health information at any time. You do this by sending written notice to the study PI. If you withdraw your permission, you will not be able to stay in this study.

What if I decide not to give permission to use and give out my health information?

Then you will not be able to be in this research study. You will be given a copy of this Informed Consent and Research Subject HIPAA Authorization describing your confidentiality and privacy rights for this study. By agreeing to this document you are permitting the University of Pennsylvania School of Medicine to use and disclose personal health information collected about you for research purposes as described above.

Who can I call with questions, complaints or if I’m concerned about my rights as a research subject?

If you have questions, concerns or complaints regarding your participation in this research study or if you have any questions about your rights as a research subject, you should speak with the PI listed on Page 1 of this form. If a member of the research team cannot be reached or you want to talk to someone other than those working on the study, you may contact the Office of Regulatory Affairs at the University of Pennsylvania with any questions, concerns or complaints by calling (215) 662-4484. Alternatively, if you have questions or concerns regarding the ethical conduct or general oversight of the study, you may call the University of Pennsylvania’s Institutional Review Board at (215)-573-2540.