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

Launched by MAYO CLINIC · May 9, 2022

Keywords

ClinConnect Summary

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 sle...

Gender

ALL

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.