Purpose: Stanford has partnered with Jazz Pharmaceuticals to conduct the DUET study. DUET is an open-label study to investigate the effects of XYWAV on sleepiness, polysomnography, and functional outcomes in participants with Idiopathic Hypersomnia (IH) or Narcolepsy (Type 1 or Type 2). This is measured through the completion of daily questionnaires, surveys, and change in polysomnogram measurements before and after treatment with XYWAV.
Inclusion:
- 18 to 75 years of age
- Have a primary diagnosis of IH or Narcolepsy (Type 1 or 2)
- If not currently taking oxybate medication, have symptoms of excessive daytime sleepiness (EDS)
- If currently treated with anticataplectics, alerting agents, or nicotine replacement therapy, be on a stable dose with no current plans to adjust the dosage.
- If currently taking oxybate medication, be willing:
- To stop it for 2 weeks prior to assessing symptoms (IH or narcolepsy)
- To discuss with your doctor the possibility of taking >9g of XYWAV nightly (narcolepsy only)
Exclusion:
- Pregnant, breastfeeding, or trying to become pregnant
- Untreated sleep disorder, or shows evidence of inadequately treated sleep apnea during baseline visit
- Succinic semi-aldehyde dehydrogenase deficiency
- Seizure disorder
- History of head trauma with loss of consciousness in the past 5 years
- Uncontrolled/untreated clinically significant psychiatric or medical disorders
- Nicotine-use disorder or excessive caffeine consumption that may impact sleep
- Currently prescribed dosage of oxybate >9g twice nightly, or single dose >6g
- Shift workers subject to unusual hours
- Plans to travel across more than 3 time zones during the study
Time commitment:
Participation in the DUET study will last between 10-21 weeks. This includes a screening period, baseline period, treatment period, and follow-up period. There will be both clinic and virtual visits. Two of these clinic visits will be overnight sleep studies. You will also be asked to take XYWAV orally every night during the treatment period, and complete daily electronic diaries during the baseline period and treatment period. All study participants will receive an active dose of XYWAV at no cost. Participants will be compensated between $3075 - $6100 for their time and effort after completing the study.
Individuals with narcolepsy have the opportunity to enroll in a cohort testing the safety and efficacy of XYWAV in a >9g twice nightly dosing schedule. This trial period will also last between 10-21 weeks; however, additional overnight sleep studies in the Redwood City Sleep Clinic will be required.
Coordinator Contact: If you think you would be a good fit for this study, please fill out the following RedCap questionnaire: https://redcap.stanford.edu/surveys/?s=XFFMPW4JMJXD7N38.
Please contact Reetu Joshi (rgjoshi@stanford.edu) with any questions.