WHAT IS THE PURPOSE OF THE STUDY?
The purpose of the study is to examine the effects of XYWAV on sleep quality and daily functioning in patients with idiopathic hypersomnia or narcolepsy.
WHO CAN PARTICIPATE?
Individuals may be eligible to participate if they:
- Are 18 to 75 years of age
- Have been diagnosed with idiopathic hypersomnia or narcolepsy
- Have excessive daytime sleepiness
- Are taking, or are willing to take, XYWAV (an oxybate drug)
WHAT HAPPENS DURING THE STUDY?
Participation lasts about 10 - 21 weeks. The screening period includes 1 office visit and 1 overnight sleep visit to determine eligibility. Eligible participants will take the study drug for 5 - 12 weeks. During this period, there will be 1 –2 overnight sleep studies, up to 4 office visits and multiple telephone calls. An end of study office visit is conducted 2 weeks after the last dose of study drug.
Some of the study procedures conducted during visits include the following:
- Review of medical history, current health, and prior and current medications
- Brief physical examination
- Blood and urine tests
- Vital signs (blood pressure, pulse, body temperature, and respiratory rate)
- Height and weight
- ECG (electrocardiogram)
- Perform a breath alcohol test
- Questionnaires about your symptoms and how they affect your daily functioning as well as how you are feeling
- Tests of attention, reaction time, and memory
- Overnight sleep testing (to monitor sleep and breathing patterns)
WILL IT COST ME ANYTHING TO PARTICIPATE IN THE STUDY?
There are no costs to take part in the study.
Participants are compensated as follows:
VISIT |
PAYMENT |
Screening Visit |
$300 |
Other Office Visits |
$200 |
Overnight Studies (PSGs) |
$900 |
Telephone Calls |
$75 |
Participants are only paid for completed visits.
HOW DO I GET MORE INFORMATION?
Complete the questions below and we will contact you for further information or call
314-205-6011.