You are being invited to take part in a research study. Your participation is voluntary, which means you can choose whether or not you want to take part in this study.

Purpose of the Screener
The purpose of the screener is to determine eligibility. We will ask you a set of questions that will ask demographic information (age, race, education, etc.) and ask you about tobacco and alcohol use, ask questions relating to sleep patterns, OSA symptoms and risk, past and current medical history including medications you take and surgeries you have had, and family history including whether you have relatives who have AD or any other kinds of dementia. The answers to these questions will help us determine if you meet the inclusion criteria for this research study.

Other Key Information
The screener will take about 30 minutes to complete. Once we have gathered all necessary information to determine eligibility, we will follow–up to schedule your Visit 1 to enroll you in this study.

The purpose of this study is to evaluate a new way of starting therapy for obstructive sleep apnea (OSA), which you have been previously shown to have. The various types of therapy (continuous positive airway pressure (CPAP), oral appliance therapy (OAT) and positional therapy will be explained to you, and you will be able to choose the one you and your doctor feel is best. You will then be sent home with this
therapy and given 2–4 weeks to adjust to it. If you are not successful or if the therapy does not work, you will rapidly be switched to another therapy.

The overall goal is to relieve your OSA within 3 months with a therapy that works for you and that you are able to use consistently. The study will require 4 visits over a period of 18 months (about 1 and a half years). Visits 3 and 4 will be scheduled in order to conduct consent, cognitive testing, labs, questionnaires, and a brain MRI with spatial memory task before and after a night of in–lab sleep study. All results of the treatments will be available to you. Genetic testing results will not be shared with you.

The visits will take place at NYU Langone Medical Center and Mt. Sinai. There are 60 people expected to take part in this research study in total across Mount Sinai and NYU. Funds for conducting this research study are provided by National Institute of Health (NIH). This is not a clinical trial. You will receive compensation for participating in this study. You will be asked for permission to store your research specimens, data and contact information for future research.

Foreseeable Risk and Benefits
A comprehensive list of all possible risk and discomforts related to this research is included in the full consent, however the most common risk for completing the screening questions is privacy risk. We ensure that all data collected for screening purposes will be strictly confidential and will be kept in password protected computers and in locked file cabinets. Your information can be used for general reporting of how many people completed the screening, how many didn’t meet inclusion criteria, and how many decided not to participate in the research study.

You may benefit personally from being in this study if we determine you are eligible. The potential benefits to society are considerable if this study reveals new information about more effective treatment of OSA, and the effects of OSA treatment for reducing AD risk in African American elderly.

Maintaining Confidentiality – HIPAA Authorization
As part of this study, some of your private and/or protected health information will be obtained, used, and shared with your permission. There is a Federal Health Insurance Portability and Accountability Act (HIPAA) that makes sure this is done correctly and safely.

What is protected health information (PHI)?
PHI is the combination of two things:

1. PHI contains information that identifies you. It will be used to contact you and link you to your health information, like name, date of birth, medical record number, and address.
2. PHI also contains health information, including information about your mental and physical health from your visits to doctors or hospitals, or from study visits.
   

Every time you visit a hospital or your doctor, PHI is created and recorded in your medical record by your healthcare providers. In the same way, the PHI created as part of this study will be linked to who you are and your medical information.

What PHI is collected and used in this research study, and might also be shared with others?
As part of this research project, the research team at the hospital(s) involved in the research will collect your name, medical record number, address, dates, date of birth, telephone number, fax number, and email address.

The researchers will also get information from your medical record at the Mount Sinai Integrative Sleep Center.

During the study, the researchers will gather information by:

• Reviewing and/or taking your medical history (includes current and past medications or therapies, illnesses, conditions or symptoms, family medical history, allergies, etc.)
• Doing a physical examination that generally also includes blood pressure reading, heart rate, breathing rate, and temperature.
• Completing the tests, procedures, questionnaires and interviews explained in the description section of this consent.

Why is your PHI being used?
Researchers need the information that identifies you so they can contact you during the study. They need your health information and the results of any tests and procedures being collected as part of this study to answer the questions posed in the study. The purpose of the study is discussed earlier in this consent form. Before researchers analyze the data, they remove any information that would let others know who you are or that you took part in the study. If researchers publish or present study results at scientific meetings, lectures, or other events, their presentations would not include any information that would let others know who you are, unless you give separate permission to do so.

The Lead Researcher may also use and share the results of these tests and procedures with other healthcare providers at NYU who are involved in your care or treatment. The research team and other authorized members of NYU workforce may use and share your information to ensure that the research meets legal, institutional or accreditation requirements. For example:

• The NYU Program for the Protection of Human Subjects is responsible for overseeing research on human participants and may need to see your information.
• If you receive any payments for taking part in this study, the NYU Finance Department may need your name, address, social security number, payment amount, and related information for tax reporting purposes.
• If the research team uncovers abuse, neglect, or reportable diseases, this information may be disclosed to appropriate authorities.
  

Who, outside NYU, might receive your PHI?
As part of the study, the Lead Researcher, research team and others in the NYU workforce may disclose your PHI, including the results of the research study tests and procedures, to the following people or organizations: (It is possible that there may be changes to the list during this research study; you may request an up–to–date list at any time by contacting the Lead Researcher.)

• The United States Department of Health and Human Services (DHHS) and the Office of Human Research Protection (OHRP) (the government organization that is responsible for protecting human research participants).
• Other collaborating research center(s) and their associated research/clinical staff who are working with the investigators on this project: NYU Grossman School of Medicine. will aid in the collection of questionnaires, labs and biofluid analysis.
  

In almost all disclosures outside of NYU, you will not be identified by name, social security number, address, telephone number, or any other direct personal identifier. Some records and information disclosed may be identified with a unique code number. The Lead Researcher will ensure that the key to the code will be kept in a locked file or will be securely stored electronically. The code will not be used to link the information back to you without your permission, unless the Institutional Review Board (IRB) allows it after determining that there would be minimal risk to your privacy. The Certificate of Confidentiality obtained from the Department of Health and Human Services will not be used to prevent disclosure to local authorities of child abuse and neglect, or harm to self or others. It is possible that a sponsor or their representatives, a data coordinating office, a contract research organization, may come to inspect your records. Even if those records are identifiable when inspected, the information leaving the institution will be stripped of direct identifiers. Additionally, OHRP, as well as the Food and Drug Administration (FDA) will be granted direct access to your medical records for verification of the research procedures and data. OHRP and FDA are authorized to remove information with identifiers if necessary to complete their task. By signing this document, you are authorizing this access. The results of this research may be published. However, your name and other identifying information will be kept confidential.

For how long will NYU be able to use or disclose your PHI?
Your authorization for use of your PHI for this specific study does not expire.

Will you be able to access your records?
During your participation in this study, you will have access to your medical record and any study information that is part of that record. The research team is not required to release research information to you that is not part of your medical record.

Do you need to give the researchers permission to obtain, use or share your PHI?
NO! If you decide not to let the research team obtain, use or share your PHI, you should not sign this form, and you will not be allowed to volunteer in the research study. If you do not sign, it will not affect your treatment, payment, or enrollment in any health plans or affect your eligibility for benefits.

Can you change your mind?
If you decide to stop being in the study, please contact the Lead Researcher or the research staff. The research team may ask you whether they can continue to collect information from your medical record. You will also have to decide if you wish to limit the continued use of the information collected during the study. Under US privacy laws you may also withdraw your permission for the researchers to use and share any of your protected information for research, but you must do so in writing to the Lead Researcher at the address on the first page.

Even if you withdraw your permission, the Lead Researcher may still use the information that was already collected, but only to complete this research study. Your health information may still be used or shared after you withdraw your authorization if you have an adverse event (a bad effect) from taking part in the research study.

It is important for you to understand that once information is disclosed to others outside NYU, the information may be re–disclosed and will no longer be covered by the federal privacy protection regulations. However, where possible, NYU has entered into agreements with those who will receive your information to continue to protect your confidentiality.

If researchers are reviewing your medical records or asking questions about your medical history or conditions, it is possible that they may learn information related to your HIV status. If that is the case, the following information concerns you. If researchers are not reviewing your medical records or asking questions about your medical history or conditions, then you may ignore the following section.
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Notice Concerning HIV–Related Information
If you are authorizing the release of HIV–related information, you should be aware that the recipient(s) is (are) prohibited from re–disclosing any HIV–related information without your authorization unless permitted to do so under federal or state law. You also have a right to request a list of people who may receive or use your HIV–related information without authorization. If you experience discrimination because of the release or disclosure of HIV–related information, you may contact the New York State Division of Human Rights at (888) 392–3644 or the New York City Commission on Human Rights at (212) 416–0197. These agencies are responsible for protecting your rights.