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Low Sodium Oxybate in Patients With Idiopathic Hypersomnia
NCT05837091 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DRUG Low Sodium Oxybate
- DIAGNOSTIC_TEST 24-hour polysomnography
- DEVICE Nextsense EEG earbuds
- DEVICE Axivity device
Study Locations (4)
Arizona
- Mayo Clinic Arizona — Phoenix
California
- Stanford University — Redwood City
Florida
- Mayo Clinic Florida — Jacksonville
Massachusetts
- Beth Israel Deaconess Medical Center — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-02-14 |
| Est. Completion | 2026-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05837091
The ClinicalTrials.gov registry entry for NCT05837091 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 3,246 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Idiopathic Hypersomnia appearing as the primary indexed condition, and to 4 interventions — of which Low Sodium Oxybate is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05837091 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Arizona, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05837091 about?
NCT05837091 is a clinical study titled "Low Sodium Oxybate in Patients With Idiopathic Hypersomnia". 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 a...
What is the current status of trial NCT05837091?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2024-02-14. Estimated completion is 2026-06.
What conditions does trial NCT05837091 study?
This clinical trial studies the following conditions: Idiopathic Hypersomnia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05837091?
The interventions under investigation include: Low Sodium Oxybate (DRUG), 24-hour polysomnography (DIAGNOSTIC_TEST), Nextsense EEG earbuds (DEVICE), Axivity device (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05837091?
This trial is sponsored by Mayo Clinic, which has 3,246 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05837091 being conducted?
This trial has 4 study locations across Arizona, California, Florida, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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