Low Sodium Oxybate for Idiopathic Hypersomnia

This study is looking at how a medicine called Low Sodium Oxybate affects people with Idiopathic Hypersomnia (IH). IH is a condition where you feel very sleepy during the day, even after a long night's sleep. Low Sodium Oxybate is already approved by the FDA for IH. Researchers want to understand how this medicine changes how long people with IH sleep. They will also use new tools, like special earbuds and a wristband, to track when you are awake or asleep. You may be able to join if you are 18-65 years old, have an IH diagnosis, and usually sleep 9 or more hours a day, including naps. The main goal is to see how your total sleep time changes after 3 months on the medication.

Study design
This is an interventional study with 30 planned participants. The phase is not specified, and the status is unclear.
What's involved
You would take Low Sodium Oxybate, which will be adjusted to find the right dose, and continue on that dose for 3 months. You will have a 24-hour sleep study (polysomnography), wear special earbuds for 24 hours, and wear a wristband for about one month.
Compensation
Not stated in the trial record.
Follow-up
Your total sleep time will be measured at the beginning of the study and again after 3 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05837091

Low Sodium Oxybate in Patients With Idiopathic Hypersomnia

Recruiting
PHASE4Ages 18–65InterventionalTreatment
Mayo Clinic
~30 participants
Updated 2026-05-12 on ClinicalTrials.gov
What's tested:Low Sodium Oxybate24-hour polysomnographyNextsense EEG earbudsAxivity device

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Total Sleep Time
Measured over Baseline, 3 months
Idiopathic Hypersomnia
4 sites across 4 states
Arizona1
California1
Florida1
Massachusetts1
  • Chad Ruoff, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

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  • Change in Total Sleep TimeBaseline, 3 months

    Measured by the 24-hour polysomnography reported as total minutes a participant is deemed sleeping.