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Low Sodium Oxybate in Patients With Idiopathic Hypersomnia

NCT05837091 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-12

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Chad Ruoff, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-14
Primary Completion
2027-01-29
Completion
2027-06-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05837091 on ClinicalTrials.gov