Low Sodium Oxybate in Patients With Idiopathic Hypersomnia
ConditionIdiopathic Hypersomnia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMayo Clinic
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.
Eligibility criteria
Qualifiers
Primary diagnosis of IH, according to ICSD-3 criteria (does not require MSLT)
Subjects aged 18 - 65 years
BMI between 18 and 35 kg/m2
Self-reported sleep duration ≥ 9 hours most days including daytime naps/sleep based upon at least 10/14 days of completed sleep diary entries
Disqualifiers
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 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
Change to psychiatric medication(s)/stimulant(s) within last 3 months
Trial design
Treatments tested in this trial
- Low Sodium Oxybate
- 24-hour polysomnography
- Nextsense EEG earbuds
- Axivity device
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov