Effect of Low Sodium Oxybate (LXB) on Autonomic Symptom Burden in Idiopathic Hypersomnia Patients With Postural Tachycardia Syndrome

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University

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

Qualifiers

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

Treatments tested in this trial

  • Low sodium oxybate (LXB)
  • Placebo

Treatment groups

25 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators