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NCT05837091 · ClinicalTrials.gov registry record · Phase 4
Low Sodium Oxybate in Patients With Idiopathic Hypersomnia
A Phase 4 study of Idiopathic Hypersomnia, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
- 4
- Study locations
NCT05837091: Recruiting Phase 4 study of Idiopathic Hypersomnia, sponsored by Mayo Clinic.
NCT05837091 is a Phase 4 study of Idiopathic Hypersomnia that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 30 participants, below the 117-participant average among 7 other Idiopathic Hypersomnia trials with a reported enrollment target (74% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05837091, a Phase 4 study of Idiopathic Hypersomnia, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
- 4
- Study locations
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.
Primary Outcome
Measured by the 24-hour polysomnography reported as total minutes a participant is deemed sleeping.
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 |
What NCT05837091 shows while recruiting
NCT05837091 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 117-participant average among 7 other Idiopathic Hypersomnia trials with a reported enrollment target (74% lower).
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.
NCT05837091 reports a single indexed study location in Arizona, California, Florida.
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.
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).
Who is sponsoring clinical trial NCT05837091?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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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