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Enrolling By Invitation
NCT05371483
Cardiovascular and Cognitive Implications of Central Disorders of Hypersomnolence and Their Treatments
Conditions: Narcolepsy, Idiopathic Hypersomnia
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Enrollment: 100
Sponsor: Mayo Clinic
Location: Mayo Clinic Arizona Scottsdale Arizona
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* 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 Criteria:
* 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.
Source: ClinicalTrials.gov (NCT05371483). StuddyBuddy aggregates publicly available trial information.