Impact of Low Sodium Oxybate on Total Sleep Time in Patients With Idiopathic Hypersomnia
Mayo Clinic
Summary
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.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugLow Sodium Oxybate
Titrated according to standard of care and continued on stable dose for 3 months
- Diagnostic Test24-hour polysomnography
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
- DeviceNextsense EEG earbuds
Ear buds used to record sleep staging worn for a 24-hours period
- DeviceAxivity device
Wristband that records activity level worn for approximately one month to track sleep and steps/activity.
Locations (4)
- Mayo Clinic ArizonaPhoenix, Arizona
- Stanford UniversityRedwood City, California
- Mayo Clinic FloridaJacksonville, Florida
- Beth Israel Deaconess Medical CenterBoston, Massachusetts