Effect of Low Sodium Oxybate (LXB) on Autonomic Symptom Burden in Idiopathic Hypersomnia Patients… (NCT07077278) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Effect of Low Sodium Oxybate (LXB) on Autonomic Symptom Burden in Idiopathic Hypersomnia Patients With Postural Tachycardia Syndrome
25 participantsStarted 2025-10-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall COMPASS-31 Score as a measure of direct comparison between the two conditions across the two-week randomized withdrawal period.
Timeframe: At the end of the two-week randomized withdrawal period
. 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