Idiopathic Hypersomnia study pre-screening questionnaire |
The purpose of this pre-screening survey is to see if you meet the criteria for taking part in our clinical research study to look at the effect of low sodium oxybate on total sleep time in order to better understand idiopathic hypersomnia (IH). This study will be conducted across multiple sites in collaboration with the Mayo Clinic.
We are currently seeking patients who have been diagnosed with idiopathic hypersomnia and have been prescribed, or at least recommended, to start low sodium oxybate. This study is important because there have been relatively few research on oxybate in IH, and it will be crucial for this indication.
Study participation involves completing four 24-hour sleep studies, two prior to starting low sodium oxybate and two 24-hour sleep studies after you are on a stable dose of low sodium oxybate. Two sleep studies will be in a sleep lab, and two will be in your own home.
Additionally, during the 6 to 7 onsite study visits, you will answer questionnaires, give blood samples, and complete physical examinations. We anticipate that the entire study will take 3 to 5 months to complete, depending on how long it takes for you and the study investigator to find an optimal, stable dose of low sodium oxybate.
You will receive $20 for each study visit you complete, for total compensation up to $180. Additionally, you will have access to the results of your 24-hour sleep study, which you can share with your doctor.
If you are interested in taking part, please complete the pre-screening questionnaire below to see if you are eligible to participate. The survey will take about 5-10 minutes to complete.
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 interview is very small. The screening interview 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.
The benefit to you of taking part in this interview is that you will find out whether you can take part in this survey.
You will not be paid for answering questions in this interview 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!