NCT05837091

Low Sodium Oxybate in Patients With Idiopathic Hypersomnia

Impact of Low Sodium Oxybate on Total Sleep Time in Patients With Idiopathic Hypersomnia

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Idiopathic Hypersomnia

Interventions

Type	Name	Description
DRUG	Low Sodium Oxybate	Titrated according to standard of care and continued on stable dose for 3 months
DIAGNOSTIC_TEST	24-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
DEVICE	Nextsense EEG earbuds	Ear buds used to record sleep staging worn for a 24-hours period
DEVICE	Axivity device	Wristband that records activity level worn for approximately one month to track sleep and steps/activity.

Timeline

• Start date: 2024-02-14
• Primary completion: 2026-01-29
• Completion: 2026-06-01
• First posted: 2023-05-01
• Last updated: 2025-07-14

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study