Using low sodium oxybate to improve sleep in patients with idiopathic hypersomnia

Impact of Low Sodium Oxybate on Total Sleep Time in Patients With Idiopathic Hypersomnia

This study is testing if low sodium oxybate can help people with idiopathic hypersomnia sleep better and stay asleep longer.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Mayo Clinic (Academic / other)
• Locations: 4 sites (Phoenix, Arizona and 3 other locations)
• Trial ID: NCT05837091 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of low sodium oxybate on individuals diagnosed with idiopathic hypersomnia, focusing on their ability to maintain prolonged sleep. The study employs advanced monitoring techniques, including 24-hour polysomnography and innovative EEG earbuds, to accurately assess sleep patterns and wakefulness. Participants will be closely monitored to evaluate the efficacy of the treatment as part of their routine medical care, with adjustments made by clinical sleep specialists.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a primary diagnosis of idiopathic hypersomnia and specific sleep duration and sleepiness criteria.

Not a fit: Patients who do not meet the eligibility criteria or have not been recommended low sodium oxybate by a clinical sleep specialist may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly enhance the quality of sleep and overall well-being for patients suffering from idiopathic hypersomnia.

How similar studies have performed: Previous studies have shown positive outcomes with low sodium oxybate for sleep disorders, indicating a promising approach for idiopathic hypersomnia.

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 entries
5. Epworth Sleepiness Scale (ESS) ≥ 10 (required at pre-screening visit only)
6. Recommended LSO by a clinical sleep specialist as part of routine medical care. The clinical sleep specialist will be responsible for titrating LSO according to standard of care.
7. Subject must be willing to postpone LSO therapy until all baseline assessments completed
8. If treated with wake promoting agents, traditional stimulants and/or antidepressant(s), a stable dose and regimen will be required for at least 2 months before study entry and throughout the main study
9. Have used a medically acceptable method of contraception for at least 2 full menstrual cycles before participating in this study and consent to use a medically acceptable method of contraception from the first dose of study drug, throughout the entire study period, and for 30 days after the last dose of study drug.

Exclusion Criteria:

1. Succinic semialdehyde dehydrogenase deficiency, porphyria
2. Other central nervous system diseases: neurodegenerative diseases, , seizure disorders or history of head trauma associated with loss of consciousness
3. Lifetime history of suicide attempt or suicidal ideation in the past six months, including answer to question #9 on PHQ-9 ≥1; PHQ-9 total score \> 10; prior history of psychotic episodes; active major depressive disorder
4. Change to psychiatric medication(s)/stimulant(s) within last 3 months
5. History of chronic alcohol or drug abuse within the prior 12 months
6. Malignant neoplastic disease requiring therapy within the prior 12 months
7. Heart failure, severe hypertension or other cardiovascular disease compromising the patient's well-being or ability to participate in this study
8. Renal or hepatic impairment
9. Compromised respiratory function (e.g., history of COPD, pulmonary hypertension, and/or poorly controlled asthma)
10. Diagnosis of sleep-related breathing disorders (AHI ≥ 15 events/h using 4 % AHI) or high suspicion for sleep disordered breathing
11. Any sleep apnea treatment (e.g., Positive Airway Pressure (PAP) therapy, oral appliance therapy, etc.)
12. No regular sleep at night: shift work or other continuous, non-disease-related life conditions
13. Participation in another study of an investigational drug within the 28 days prior to Screening visit or currently
14. Pregnant and/or breast-feeding
15. Ear jewelry and/or piercings that subject not willing to/unable to remove
16. Use of device/implant that may interfere with the study devices/procedures (e.g., vagal nerve stimulator)
17. Smoke and/or use of smokeless tobacco products
18. Subjects who, in the opinion of the investigator(s), may not be suitable for the study

Where this trial is running

Phoenix, Arizona and 3 other locations

• Mayo Clinic Arizona — Phoenix, Arizona, United States (Recruiting)
• Stanford University — Redwood City, California, United States (Recruiting)
• Mayo Clinic Florida — Jacksonville, Florida, United States (Recruiting)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Chad Ruoff, MD — Mayo Clinic
• Study coordinator: Gabbi Montefiore

Conditions Idiopathic Hypersomnia