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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low sodium oxybate (LXB) | Experimental | Participants will take LXB for two weeks. |
|
| Placebo | Placebo Comparator | Participants will take placebo for two weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the end of the two-week randomized withdrawal period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jordan Seliger | Contact | 650-460-9260 | autonomicresearch@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mitchell Miglis, MD | Stanford University | Principal Investigator |
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| Placebo | Drug | Participants will take placebo for two weeks after completing an open-label titration and dose optimization period of low sodium oxybate (LXB). |
|
| ID | Term |
|---|---|
| D020177 | Idiopathic Hypersomnia |
| D054972 | Postural Orthostatic Tachycardia Syndrome |
| ID | Term |
|---|---|
| D006970 | Disorders of Excessive Somnolence |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
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