Status:
ENROLLING_BY_INVITATION
Cardiovascular and Cognitive Implications of Central Disorders of Hypersomnolence and Their Treatments
Lead Sponsor:
Mayo Clinic
Conditions:
Narcolepsy
Idiopathic Hypersomnia
Eligibility:
All Genders
18-75 years
Brief 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 bette...
Detailed Description
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 wi...
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.
Key Trial Info
Start Date :
May 18 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05371483
Start Date
May 18 2022
End Date
July 1 2026
Last Update
June 29 2025
Active Locations (1)
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1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259