Actively Recruiting
Low Sodium Oxybate in Patients With Idiopathic Hypersomnia
Led by Mayo Clinic · Updated on 2026-05-12
30
Participants Needed
4
Research Sites
171 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Low Sodium Oxybate in Patients With Idiopathic Hypersomnia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary diagnosis of idiopathic hypersomnia according to ICSD-3 criteria
- Age between 18 and 65 years
- Body mass index (BMI) between 18 and 35 kg/m2
- Self-reported sleep duration of at least 9 hours most days including naps based on sleep diary entries
- Epworth Sleepiness Scale score of 10 or higher at pre-screening
- Recommended low sodium oxybate by a clinical sleep specialist with titration per standard care
- Willingness to delay starting low sodium oxybate until all baseline assessments are completed
- Stable dose and regimen of wake promoting agents, stimulants, or antidepressants for at least 2 months before and during the study if applicable
- Use of medically acceptable contraception for at least 2 full menstrual cycles before participation and agreement to continue during and 30 days after the study
You will not qualify if you...
- Succinic semialdehyde dehydrogenase deficiency or porphyria
- Other central nervous system diseases including neurodegenerative diseases, seizure disorders, or history of head trauma with loss of consciousness
- Lifetime history of suicide attempt or recent suicidal ideation, psychotic episodes, or active major depressive disorder
- Change in psychiatric medications or stimulants in the last 3 months
- History of chronic alcohol or drug abuse within the past 12 months
- Malignant cancer requiring treatment within the past 12 months
- Heart failure, severe hypertension, or cardiovascular disease affecting participation
- Kidney or liver impairment
- Compromised respiratory function such as COPD, pulmonary hypertension, or poorly controlled asthma
- Diagnosis or suspicion of sleep-related breathing disorders or sleep apnea treatment
- Irregular sleep patterns due to shift work or other non-disease-related conditions
- Participation in another investigational drug study within 28 days prior or currently
- Pregnancy or breastfeeding
- Ear jewelry or piercings that cannot be removed
- Use of devices or implants interfering with study devices
- Use of tobacco products
- Investigator's judgment of unsuitability for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Stanford University
Redwood City, California, United States, 94063
Actively Recruiting
3
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
4
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
G
Gabbi Montefiore
CONTACT
A
Arleth Valencia
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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