About this trial
The investigators hope to learn if low sodium oxybate (LXB) is an effective treatment for symptoms of idiopathic hypersomnia (IH) and postural tachycardia syndrome (POTS). Previous research has shown that patients with IH also report having symptoms associated with POTS. The researchers have observed that in patients with both IH and POTS, when patients' sleep quality improves, so do their POTS symptoms. The goal of this study is to test this in a controlled way by using LXB as a treatment for both IH and POTS in patients that have been diagnosed with both conditions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
English speaking and capable of signing the informed consent form and comply with the protocol requirements
Diagnosis of IH based on ICSD-3 criteria
Diagnosis of POTS based on the 2011 Consensus Criteria
Disqualifiers
Hypersomnia due to another medical, behavioral, sleep, or psychiatric disorder
Evidence of untreated or inadequately treated sleep disordered breathing, defined as AHI ≥ 10
History of bipolar or psychotic disorders, major depressive episode, or current suicidal risk
Pregnant or lactating or intends to become pregnant during the study
Trial design
Parallel
Treatments tested in this trial
Low sodium oxybate (LXB)
DrugParticipants will continue take low sodium oxybate (LXB) for two weeks after completing an open-label titration and dose optimization period of low sodium oxybate (LXB).
Placebo
DrugParticipants will take placebo for two weeks after completing an open-label titration and dose optimization period of low sodium oxybate (LXB).
Treatment groups
Trial outcomes
Primary outcomes
Overall COMPASS-31 Score as a measure of direct comparison between the two conditions across the two-week randomized withdrawal period.
The Composite Autonomic Symptom Severity Scale-31 (COMPASS-31) is an overall assessment of autonomic symptom severity. The scale measures neurodegenerative system symptoms through 31 patient-reported questions. Assessment is through six weighted domains: orthostatic intolerance \[10 points\]; vasomotor \[6 points\]; secretomotor \[7 points\]; gastrointestinal \[28 points\]; bladder \[9 points\] and pupillomotor \[15 points\]. Weighted scores are summed. A higher score indicates worse autonomic dysfunction.
Locations
Sponsors and contacts
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