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Low sodium oxybate has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic hypersomnia. In this study, the researchers want to learn how low sodium oxybate impacts ability of people diagnosed with idiopathic hypersomnia to sleep for long periods of time. In addition, this study will use novel tools to determine when an individual is awake or asleep.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Soduim Oxybate for Idiopathic Hypersomnia | Experimental | Subjects prescribed with low sodium oxybate for idopathic hypersomnia will have a 24-hour polysomnography, wear an Axivity wristband and Nextsense EEG earbuds to evaluate total sleep time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Sodium Oxybate | Drug | Titrated according to standard of care and continued on stable dose for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Sleep Time | Measured by the 24-hour polysomnography reported as total minutes a participant is deemed sleeping. | Baseline, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total sleep time as measured by Nextsense EEG earbuds | Measured by the Nextsense EEG earbuds reported as total minutes a participant is deemed sleeping. | Baseline, 3 months |
| Change in total sleep time as measured by Axivity device |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabbi Montefiore | Contact | (480)574-1288 | montefiore.gabrielle@mayo.edu | |
| Arleth Valencia | Contact | (480)342-6487 | Valencia.Arleth@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Chad Ruoff, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Recruiting | Phoenix | Arizona | 85054 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D020177 | Idiopathic Hypersomnia |
| ID | Term |
|---|---|
| D006970 | Disorders of Excessive Somnolence |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| D002118 | Calcium |
| D008274 | Magnesium |
| D011188 | Potassium |
| D017286 | Polysomnography |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
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| 24-hour polysomnography | Diagnostic Test | Performed in a sleep study lab, recording of body functions including brain activity, eye movements, muscle activity, heart rhythm and blood oxygen levels while asleep and awake for a 24-hour period |
|
| Nextsense EEG earbuds | Device | Ear buds used to record sleep staging worn for a 24-hours period |
|
| Axivity device | Device | Wristband that records activity level worn for approximately one month to track sleep and steps/activity. |
|
Measured by the Axivity device reported as total minutes a participant is deemed sleeping.
| Baseline, 3 months |
| Change in total sleep time as measured by patient sleep diary | Measured by patient sleep diary entries as total minutes a participant reported sleeping. | Baseline, 3 months |
| Stanford University | Recruiting | Redwood City | California | 94063 | United States |
|
| Mayo Clinic Florida | Recruiting | Jacksonville | Florida | 32224 | United States |
|
| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
|
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D001779 |
| Blood Coagulation Factors |
| D001685 | Biological Factors |
| D019565 | Metals, Light |
| D008672 | Metals, Alkali |
| D008991 | Monitoring, Physiologic |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |