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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Low sodium oxybate (LXB)

    Drug

    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).

  • Placebo

    Drug

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

Treatment groups

25 Participants
are divided into 2 treatment groups
Group A: Low sodium oxybate (LXB)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At the end of the two-week randomized withdrawal period

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: