Clinical Trials

Inclusion Criteria:

• Diagnosis of Idiopathic Hypersomnia, according to ICSD-3 criteria.
• Subjects age 18 – 65 years.
• BMI between 18 and 35 kg/m^2.
• Self-reported sleep duration of ≥ 10 hours.
• Epworth Sleepiness Scale (ESS) ≥ 10.
• Prescribed low sodium oxybate (LSO) by a clinical sleep specialist as part of routine medical care and clinical sleep specialist willing to actively manage LSO through the study (i.e., LSO not prescribed by nor managed by study investigators unless the study investigator also happens to be the treating clinical sleep medicine specialist for the patient)   .
• Subject willing to postpone LSO therapy until completion of all baseline assessments.

Exclusion Criteria:

• Succinic semialdehyde dehydrogenase deficiency, porphyria.
• Other central nervous system diseases: neurodegenerative diseases, seizure disorders or history of head trauma associated with loss of consciousness.
• Lifetime history of suicide attempt or suicidal ideation in the past 6 months, prior history of psychotic episodes, current or recent history of a major depressive disorder (DSM-V), Beck depression inventory (BDI) > 16 and/or item G > 0.
• History of chronic alcohol or drug abuse within the prior 12 months.
• Malignant neoplastic disease requiring therapy within the prior 12 months.
• Heart failure, severe hypertension or other cardiovascular disease compromising the patient's wellbeing or ability to participate in this study.
• Renal or hepatic impairment.
• Compromised respiratory function.
• Diagnosis of sleep-related breathing disorders (AHI ≥ 10 events/h) not being adequately treated.
• No regular sleep at night: shift work or other continuous, non-disease-related life conditions
• Participation in another study of an investigational drug within the 28 days prior to Screening visit or currently.
• Pregnancy (βHCG positive) and breast-feeding.