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This is an observational study evaluating patients diagnosed with narcolepsy or idiopathic hypersomnia that have been prescribed a new/different hypersomnia treatment. The study is being done to better understand how hypersomnia treatment(s) impact blood pressure and cognitive function.
This is an observational study evaluating how hypersomnia medications influence blood pressure and cognitive function in patients diagnosed with narcolepsy or idiopathic hypersomnia. Blood pressure will be assessed using 24-hour ambulatory blood pressure monitoring equipment. Cognitive function will be evaluated using the Oculo-Cognitive Addition Test (OCAT). Both tests will performed at baseline (e.g., before starting a new hypersomnia medication) and after taking a stable dose of the new hypersomnia medication for at least three months. All medications will be prescribed by a clinical sleep specialist as part of routine medical care and covered by subject's health insurance plan (i.e., no medications are dispensed/titrated/paid for by the study investigators/trial).
The 24-hour ambulatory blood pressure test will be setup in person by staff. During the blood pressure test, the study participant will also complete a sleep diary and wear an actigraphy watch to track activity and sleep-wake cycle. The 24-hour ambulatory blood pressure test will be programmed to inflate a blood pressure cuff placed around the arm every 15 - 30 minutes.
The OCAT test, which takes approximately 15-20 minutes to complete, will be completed in person as well.
Each study participant may complete one or both tests. Each study participant may complete more than two assessments (e.g., patient that has been prescribed a second hypersomnia medication). If a patient presents already taking a medication of interest at baseline for at least the last 3 months then the participant may undergo baseline assessment(s) while taking respective medication(s).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Narcolepsy Type 1 | Study participant will complete test(s) before and after taking a stable dose of a new/different hypersomnia medication. All hypersomnia medications will be prescribed and titrated by a clinical sleep specialist outside of this protocol. |
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| Narcolepsy Type 2 | Study participant will complete test(s) before and after taking a stable dose of a new/different hypersomnia medication. All hypersomnia medications will be prescribed and titrated by a clinical sleep specialist outside of this protocol. |
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| Idiopathic Hypersomnia | Study participant will complete test(s) before and after taking a stable dose of a new/different hypersomnia medication. All hypersomnia medications will be prescribed and titrated by a clinical sleep specialist outside of this protocol. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 24-hour Ambulatory Blood Pressure Monitoring | Diagnostic Test | Arm blood pressure cuff that will automatically inflate every 15-30 minutes to check blood pressure while awake and asleep over 24 hours. Patient will also complete a sleep diary and wear an actigraphy watch during this test. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean 24-hour ambulatory blood pressure | Change in 24-hour ambulatory blood pressure from baseline (pre-treatment) to after taking a stable dose of medication for at least 3 months | Baseline, at least 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Oculo-Cognitive Addition Test (OCAT) completion time | Change in OCAT completion time from baseline (pre-treatment) to after taking a stable dose of medication for at least 3 months (post-treatment) | Baseline, at least 3 months |
| Change in mean daytime and nighttime 24-hour ambulatory blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with narcolepsy or idiopathic hypersomnia that have been prescribed but not yet started a new/different hypersomnia medication.
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| Name | Affiliation | Role |
|---|---|---|
| Chad Ruoff, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Scottsdale | Arizona | 85259 | United States |
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| ID | Term |
|---|---|
| D009290 | Narcolepsy |
| 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 |
|---|---|
| D018660 | Blood Pressure Monitoring, Ambulatory |
| D056044 | Actigraphy |
| ID | Term |
|---|---|
| D001795 | Blood Pressure Determination |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Oculo-Cognitive Addition Test (OCAT) | Diagnostic Test | Tracks users' eye movements as they complete a simple mental addition test. |
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Change in mean daytime and nighttime 24-hour ambulatory blood pressure from baseline (pre-treatment) to after taking a stable dose of medication for at least 3 months (post-treatment) |
| Baseline, at least 3 months |
| Change in 24-hour ambulatory blood pressure diurnal pattern (dipper versus non-dipper) | Change in 24-hour ambulatory blood pressure diurnal pattern (dipper versus non-dipper) from baseline (pre-treatment) to after taking a stable dose of medication for at least 3 months (post-treatment) | Baseline, at least 3 months |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D018670 | Monitoring, Ambulatory |
| D008991 | Monitoring, Physiologic |
| D061725 | Accelerometry |
| D008919 | Investigative Techniques |