NCT07077278

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

Effect of Low Sodium Oxybate (LXB) on Autonomic Symptom Burden in Idiopathic Hypersomnia Patients With Postural Tachycardia Syndrome: a Placebo-controlled, Double-blind, Randomized Withdrawal Study

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Idiopathic Hypersomnia
• POTS - Postural Orthostatic Tachycardia Syndrome

Interventions

Type	Name	Description
DRUG	Low sodium oxybate (LXB)	Participants 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).
DRUG	Placebo	Participants will take placebo for two weeks after completing an open-label titration and dose optimization period of low sodium oxybate (LXB).

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2025-07-22
• Last updated: 2025-07-25

Regulatory

• FDA-regulated drug study