RecruitingPhase 4NCT05837091

Low Sodium Oxybate in Patients With Idiopathic Hypersomnia

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

Sponsor

Mayo Clinic

Enrollment

30 participants

Start Date

Feb 14, 2024

Study Type

INTERVENTIONAL

Conditions

Idiopathic Hypersomnia

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying 24-hour polysomnography, Axivity device, and others for people with idiopathic hypersomnia. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.