Mayo Clinic
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.
Inclusion Criteria: 1. Primary diagnosis of IH, according to ICSD-3 criteria (does not require MSLT) 2. Subjects aged 18 - 65 years 3. BMI between 18 and 35 kg/m2 4. Self-reported sleep duration ≥ 9 hours most days including daytime naps/sleep based upon at least 10/14 days of completed sleep diary entries 5. Epworth Sleepiness Scale (ESS) ≥ 10 (required at pre-screening visit only) 6. 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. 7. Subject must be willing to p…
Titrated according to standard of care and continued on stable dose for 3 months
Performed in a sleep study lab, recording of body functions including brain activity, eye movements, muscle activity, heart rhythm and blood oxygen levels while asleep and awake for a 24-hour period
Ear buds used to record sleep staging worn for a 24-hours period
Wristband that records activity level worn for approximately one month to track sleep and steps/activity.
Arctuva estimate
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