Looking for a Potential Effective, Lower-Sodium Treatment for Your Sleep Disorder?
Looking for a Potential Effective, Lower-Sodium Treatment for Your Sleep Disorder?
What Is Excessive Daytime Sleepiness?
Excessive daytime sleepiness is a symptom of chronic sleep disorders such as IH and narcolepsy. EDS can appear regardless of the quality of your night’s sleep—even if you feel rested after waking, you may have the uncontrollable need to sleep during the day. These episodes can come randomly and at unusual and unexpected times.
EDS can impact your day-to-day life. With a limited amount of energy, activities such as quality time with family and hobbies may be neglected.
Lack of quality sleep has been linked to the development of several chronic diseases and conditions, including1:
disease
diabetes
Why Are the Jazz Sleep Studies Important?
Many adults with IH and narcolepsy currently use a high-sodium oxybate treatment to address multiple symptoms associated with their condition. As narcolepsy, and potentially IH, carry a higher risk of developing cardiovascular disease, daily high sodium intake can be a concern. Reducing your sodium intake can help reduce the risk of high blood pressure and heart disease.
Participating in the XYLO Study or DUET Study will help advance research that may better inform how we treat sleep disorders such as IH and narcolepsy with low-sodium oxybate solutions. Without participants like you, this important research would not be possible.
See If You Qualify
If you are interested in participating in a sleep study, complete the short questionnaire to see if you may qualify. If you qualify, you will have the opportunity to provide your contact information to the study site.
About the XYLO Study
The XYLO Study will evaluate changes in blood pressure in participants with narcolepsy switching from a high-sodium oxybate to XYWAV®, a low-sodium oral solution.
Participation in the XYLO Study could last up to 11 weeks with a screening period, study treatment period and follow-up period. This study offers both in-clinic and virtual options, meaning you can participate in the XYLO Study remotely from your home, depending on your geographical location.
Participants are expected to:
- Attend clinic and/or virtual visits
- At the clinic visits, you will complete several questionnaires related to your condition and how you are feeling
- Receive study procedures like checking your blood pressure and heart rate
Who Can Take Part?
To participate in the XYLO Study, you must:
- Be 18 to 70 years of age
- Have a narcolepsy diagnosis (Type 1 or Type 2)
- Have been or will be taking a high-sodium oxybate medication
Other criteria apply.
About the DUET Study
The DUET Study aims to evaluate the daytime and nighttime effects of XYWAV.
Participation in a DUET Study cohort could last up to 5 months, including a screening period, baseline period, treatment period and follow-up period. Participants are expected to:
- Attend both clinic and virtual visits
- At the clinic visits, you will complete several questionnaires related to your condition and how you are feeling
- Some of the clinic visits will be overnight sleep studies
- Take XYWAV orally every night during the treatment period
Who Can Take Part?
The DUET Study is looking for adult participants. To join, you must:
- Be 18 to 75 years of age
- Have a primary diagnosis of IH or narcolepsy (Type 1 or Type 2)
- Have symptoms of EDS if not currently taking oxybate medication
Other criteria apply.
If you decide to join the XYLO Study or DUET Study, you will be compensated for your travel and time during the study period. Enrolling in a study is completely your choice. You may stop participating at any time during the study.
Frequently Asked Questions
What is a clinical study?
A clinical study, also known as a clinical trial, is a medical study that helps to answer important questions about a study medication or medical device. Once a study medication has been approved for use by a regulatory authority, it is not the end of clinical research. It is still important to continue to research the study medication to record any additional benefits and/or side effects.
What is the purpose of these sleep studies?
The XYLO Study is looking at how switching from a high-sodium oxybate medication, like XYREM® (sodium oxybate), to the study medication, XYWAV, can affect the blood pressure of people with narcolepsy.
The DUET Study is evaluating whether the daytime and nighttime effects of XYWAV, a low-sodium oral medication, will affect people living with idiopathic hypersomnia and narcolepsy (Type 1 or Type 2).
How will I be contacted if deemed eligible?
If you are eligible for the study upon completion of the questionnaire on this site, you will be able to discuss the study in more detail and ask questions with a research team you choose near you. You are not obligated to join the study even once you select a study location.
Is there a charge to participate in these sleep studies?
There is no charge for you to participate. If you are eligible and decide to take part, you will receive study-related care from a team of medical staff throughout the course of the studies. All study-related visits, tests, assessments and study-required medication will be provided at no charge to you.
You may be reimbursed for your time and study-related travel during the study period.
What is XYWAV?
XYWAV is the first and only lower-sodium oxybate approved by the FDA to treat cataplexy or excessive daytime sleepiness in people 7 years and older with narcolepsy. The formulation of XYWAV contains 92% less sodium than XYREM.2
Will all participants receive XYWAV?
All study participants will receive XYWAV at no charge during the study.
Where are the study sites?
There are study sites across the United States (both trials) and Canada (DUET). Virtual site participation is also available for the XYLO Study, meaning you can participate from your home and do not have to attend office visits. See if you qualify for one of the studies. If you do, you will be able to select the study site (and/or virtual participation for XYLO) that is convenient for you.
References:
- Sleep and chronic disease. Centers for Disease Control and Prevention. Updated September 13, 2022. Accessed June 1, 2023. https://www.cdc.gov/sleep/about_sleep/chronic_disease.html
- XYREM and XYWAV. Jazz Pharmaceuticals. Accessed May 25, 2023. https://www.xywav.com/narcolepsy/lower-sodium-oxybate-treatment-option/