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NCT05371483

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

Enrolling by Invitation
Not specifiedAges 18–75Observational
Mayo Clinic
~100 participants
Updated 2026-06-09 on ClinicalTrials.gov
What's tested:24-hour Ambulatory Blood Pressure MonitoringOculo-Cognitive Addition Test (OCAT)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in mean 24-hour ambulatory blood pressure
Measured over Baseline, at least 3 months

Conditions

Narcolepsy
Idiopathic Hypersomnia

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Idiopathic HypersomniaNarcolepsy

Where it's being run

1 sites across 1 states
Arizona1

Study leadership

  • Chad Ruoff, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Diagnosed with narcolepsy or idiopathic hypersomnia according to International Classification of Sleep Disorders, third edition
Age 18 - 75 years
BMI between 18 and 40 kg/m2
Prescribed a medication of interest (e.g., sodium oxybate, low sodium oxybate, pitolisant, modafinil/armodafinil, solriamfetol, traditional stimulant(s)) by a clinical sleep specialist as part of routine medical care.
Subject must be willing to postpone starting medication until after completion of baseline assessment(s).
If subject has been taking a prescribed hypersomnia medication(s) at a stable dose for at least 3 months and has been prescribed a new medication, then subject may complete baseline assessment(s) while taking initial hypersomnia medication(s) before starting new medication.

Exclusion

Any change to medication(s) within the last 45 days
History of chronic alcohol or drug abuse within the prior 12 months
Heart failure, history of severe hypertension, or other cardiovascular disease compromising the patient's wellbeing or ability to participate in this study
Use of any sleep apnea treatment (e.g., Positive Airway Pressure (PAP) therapy, oral appliance therapy, etc.) within 45 days of baseline assessment visit
Participation in another study of an investigational drug within the 28 days prior to screening visit or currently
Pregnancy and/or breast-feeding
Subjects who, in the opinion of the Investigator, may not be suitable for the study.

What this trial measures

  • Change in mean 24-hour ambulatory blood pressureBaseline, at least 3 months

    Change in 24-hour ambulatory blood pressure from baseline (pre-treatment) to after taking a stable dose of medication for at least 3 months