An observational study in Narcolepsy and Idiopathic Hypersomnia, sponsored by Mayo Clinic. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by Mayo Clinic · Observational
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).
157 studies on the registry are indexed under Narcolepsy; 37 are open to participants now.
This study's planned enrollment of 100 is below the median of 135 across 38 observational studies indexed under Narcolepsy.
Browse Narcolepsy studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients diagnosed with narcolepsy or idiopathic hypersomnia that have been prescribed but not yet started a new/different hypersomnia medication.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: 24-hour Ambulatory Blood Pressure Monitoring · Diagnostic Test: Oculo-Cognitive Addition Test (OCAT)
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.
Diagnostic Test: 24-hour Ambulatory Blood Pressure Monitoring · Diagnostic Test: Oculo-Cognitive Addition Test (OCAT)
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.
Diagnostic Test: 24-hour Ambulatory Blood Pressure Monitoring · Diagnostic Test: Oculo-Cognitive Addition Test (OCAT)
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.
Also known as: Actigraphy, Sleep diary
Tracks users' eye movements as they complete a simple mental addition test.
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
Time frame: Baseline, at least 3 months
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)
Time frame: Baseline, at least 3 months
Change in mean daytime and nighttime 24-hour ambulatory blood pressure
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)
Time frame: 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)
Time frame: Baseline, at least 3 months
Plan to share: No
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