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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: montefiore.gabrielle@mayo.edu
• Phone: (480)574-1288

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Long-term test of TAK-360 in people with narcolepsy or idiopathic hypersomnia

  This study tests TAK-360 over an extended period to see if it is tolerable for people with narcolepsy type 1, narcolepsy type 2, or idiopathic hypersomnia who completed an earlier TAK-360 trial.

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• Phase 3 HBS-301 for idiopathic hypersomnia

  This trial will test whether the oral medicine HBS-301 helps adults with idiopathic hypersomnia reduce daytime sleepiness, sleep inertia, and fatigue.

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• Diet changes to reduce sleepiness in narcolepsy and idiopathic hypersomnia

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• Evaluating TAK-360 for daytime sleepiness in adults with Idiopathic Hypersomnia

  This study is testing a new medication called TAK-360 to see if it can help adults with Idiopathic Hypersomnia feel less sleepy during the day.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.