Effect of Low Sodium Oxybate (LXB) on Autonomic Symptom Burden in Idiopathic Hypersomnia Patients With Postural Tachycardia Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low sodium oxybate (LXB), Placebo.
- Who it may be relevant to
- Registry conditions: Idiopathic Hypersomnia, POTS - Postural Orthostatic Tachycardia Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
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).
Primary outcome measures
- Overall COMPASS-31 Score as a measure of direct comparison between the two conditions across the two-week randomized withdrawal period. [Time frame: At the end of the two-week randomized withdrawal period]
Eligibility criteria
Inclusion criteria
- 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
- Oxybate naïve. Participants on daytime alerting medications at baseline can remain on these medications for the duration of the study, provided doses remain stable for the duration of the study. This rule also applies to medications prescribed for the treatment of POTS. All medications known to affect cardiovascular function will be held for the appropriate time periods prior to active stand testing so as not to influence results.
- COMPASS 31 ≥ 40 at the screening visit
- Agree to use contraceptives consistent with local regulations regarding the methods of contraception for those participating in clinical trials
Exclusion criteria
- 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
- History of or currently being treated for clinically significant ongoing cardiac arrythmia, heart failure, myocarditis, pulmonary embolism requiring anticoagulation, pulmonary fibrosis or other pulmonary diagnosis that in the investigator's opinion may contribute to symptoms of POTS
- Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection or positive SARS-CoV-2 PCR test at screening
- A medical condition that could confound the results of the study or put the participant at undue risk in the investigator's judgment
- Intends to have surgery or procedures requiring anesthesia or conscious sedation during the study
- Currently participating in another interventional clinical study
- Unwilling to remain on a stable regimen of medications during the study
- Use of or planned use of intravenous saline infusions during the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07077278 · 75300