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

Enrolling by invitation

Conditions studied: Narcolepsy, Idiopathic Hypersomnia

In brief

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 facts

Study ID

NCT05371483

Run by

Mayo Clinic

People needed

100

Starts

2022-05-18

Expected to finish

2028-07-01

Last updated by the study team

2026-06-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Mayo Clinic Arizona — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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