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

NCT07077278 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-07-25

No results posted yet for this study

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

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).

Sponsors & Collaborators

Principal Investigators

  • Mitchell Miglis, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2027-09-30
Completion
2027-09-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07077278 on ClinicalTrials.gov