Narcolepsy study (XYLO) pre-screening questionnaire |
The purpose of this pre-screening survey is to see if you meet the criteria for taking part in our research study, called XYLO. This study will be conducted across multiple sites in collaboration with Jazz Pharmaceuticals Inc.
About the XYLO Study
We want to understand more about blood pressure when people with narcolepsy change from a high-sodium oxybate medication, like XYREM, to the study medication, XYWAV. XYWAV has the same active ingredients as XYREM, but with much lower sodium content.
If you decide to take part, you will be in the study for up to 11 weeks. All participants will have a total of 8 visits with the study doctor or study team. Some of these visits will be virtual using phone and/or video calls (telemedicine).
During this study:
- You will have to wear a blood pressure cuff on your arm and the device around your waist for 25 consecutive hours twice during the study (at Visits 1 and 7).
- You will collect urine for 24 consecutive hours twice during the study (at Visits 1 and 7).
- You will be asked to answer questionnaires, give blood samples, and complete physical examinations with measurement of vital signs.
- You will continue taking medication for narcolepsy and you can continue to take your medication for hypertension if you are already taking it.
Are you interested in taking part?
We are looking for people who are 18-70 years of age, have a diagnosis of narcolepsy, and have been taking or will be taking a high-sodium oxybate medication (such as XYREM)
What else do I need to consider?
- The study team will explain the possible benefits and risks.
- If you choose to take part, you can stop at any time.
- You may be reimbursed for study visits to cover tolls, parking, and gas up to $65.
- You will receive all study medications and study-related tests at no charge.
- A team of medical staff will monitor your health carefully during the study.
By participating, you will help us learn more about narcolepsy medications and blood pressure. The results may help other people with narcolepsy in the future.
If you are interested in taking part, please complete the pre-screening questionnaire below to see if you are eligible to participate. This will take approximately 5 minutes. You will go through a list of questions. You may choose not to answer these questions. You also may choose to stop participating at any time.
Information about you that you provide for this screening will be kept as confidential as possible as required by law. It is possible that the Food and Drug Administration, and other federal and state authorities, may inspect this record.
You can choose if you want or do not want to take part in this research screening procedure - it is up to you. If you refuse to answer the questions or stop answering them at any time, there will be no penalty, and you will not lose any benefits to which you otherwise would be entitled.
The risk to taking part in this questionnaire is very small and it is not designed to ask you for sensitive personal information. Your responses will be recorded; this will be kept confidential, but there is a small risk that people outside of the research team could learn this information. If you are not interested in the study, then your responses will be destroyed and securely disposed of.
The benefit to you of taking part in this questionnaire is that you will find out whether you can take part in this study.
You will not be paid for answering questions in this survey since it is only to see whether you qualify to take part in the study.
If you have any questions, concerns, or complaints about this interview, contact Emmanuel Mignot at 650-723-5879. If you want to talk to someone separate from the research team about a concern or complaint or your rights as a possible research subject, please contact the Stanford Institutional Review Board (IRB) to speak to an informed person who is separate from the research team 1-866-680-2906.
Please complete the survey below to see if you are eligible to participate in this study.
Thank you!