Cardiovascular and Cognitive Implications of Central Disorders of Hypersomnolence and Their Treatments

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT05371483
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • Oculo-Cognitive Addition Test (OCAT) — DIAGNOSTIC_TEST
    Tracks users' eye movements as they complete a simple mental addition test.

Study Details

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.

Key Dates

Start date
May 18, 2022
Status verified
Jun 2026
Primary completion
May 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Change in mean 24-hour ambulatory blood pressure [ Time Frame: Baseline, at least 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaScottsdaleArizona85259-

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