Low Sodium Oxybate in Patients With Idiopathic Hypersomnia

PHASE4RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

February 14, 2024

Primary Completion Date

January 29, 2026

Study Completion Date

June 30, 2026

Conditions
Idiopathic Hypersomnia
Interventions
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.

Trial Locations (4)

32224

RECRUITING

Mayo Clinic Florida, Jacksonville

85054

RECRUITING

Mayo Clinic Arizona, Phoenix

94063

RECRUITING

Stanford University, Redwood City

02215

RECRUITING

Beth Israel Deaconess Medical Center, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mayo Clinic

OTHER