Impact of Low Sodium Oxybate on Total Sleep Time in Patients With Idiopathic Hypersomnia
Low sodium oxybate has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic hypersomnia. In this study, the researchers want to learn how low sodium oxybate impacts ability of people diagnosed with idiopathic hypersomnia to sleep for long periods of time. In addition, this study will use novel tools to determine when an individual is awake or asleep.
• Primary diagnosis of IH, according to ICSD-3 criteria (does not require MSLT)
• Subjects aged 18 - 65 years
• BMI between 18 and 35 kg/m2
• Self-reported sleep duration ≥ 9 hours most days including daytime naps/sleep based upon at least 10/14 days of completed sleep diary entries
• Epworth Sleepiness Scale (ESS) ≥ 10 (required at pre-screening visit only)
• Recommended LSO by a clinical sleep specialist as part of routine medical care. The clinical sleep specialist will be responsible for titrating LSO according to standard of care.
• Subject must be willing to postpone LSO therapy until all baseline assessments completed
• If treated with wake promoting agents, traditional stimulants and/or antidepressant(s), a stable dose and regimen will be required for at least 2 months before study entry and throughout the main study
• Have used a medically acceptable method of contraception for at least 2 full menstrual cycles before participating in this study and consent to use a medically acceptable method of contraception from the first dose of study drug, throughout the entire study period, and for 30 days after the last dose of study drug.