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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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
Mayo Clinic Arizona
Phoenix, Arizona, United States
RECRUITINGStanford University
Redwood City, California, United States
RECRUITINGMayo Clinic Florida
Jacksonville, Florida, United States
RECRUITINGChange in Total Sleep Time
Measured by the 24-hour polysomnography reported as total minutes a participant is deemed sleeping.
Time frame: Baseline, 3 months
Change in total sleep time as measured by Nextsense EEG earbuds
Measured by the Nextsense EEG earbuds reported as total minutes a participant is deemed sleeping.
Time frame: Baseline, 3 months
Change in total sleep time as measured by Axivity device
Measured by the Axivity device reported as total minutes a participant is deemed sleeping.
Time frame: Baseline, 3 months
Change in total sleep time as measured by patient sleep diary
Measured by patient sleep diary entries as total minutes a participant reported sleeping.
Time frame: Baseline, 3 months
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Wristband that records activity level worn for approximately one month to track sleep and steps/activity.
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
RECRUITING