Low Sodium Oxybate in Patients With Idiopathic Hypersomnia

Recruiting Phase 4 Interventional Study
Idiopathic Hypersomnia
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Mayo Clinic · Other
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Primary diagnosis of IH, according to ICSD-3 criteria (does not require MSLT) 2. Subjects aged 18 - 65 years 3. BMI between 18 and 35 kg/m2 4. Self-reported sleep duration ≥ 9 hours most days including daytime naps/sleep based upon at least 10/14 days of completed sleep diary…
Contacts

Gabbi Montefiore

(480)574-1288

montefiore.gabrielle@mayo.edu

CONTACT

Arleth Valencia

(480)342-6487

Valencia.Arleth@mayo.edu

CONTACT