Cardiovascular and Cognitive Implications of Central Disorders of Hypersomnolence and Their Treatments
1 other identifier
observational
100
1 country
1
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 better understand how hypersomnia treatment(s) impact blood pressure and cognitive function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2022
CompletedFirst Posted
Study publicly available on registry
May 12, 2022
CompletedStudy Start
First participant enrolled
May 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
ExpectedJune 29, 2025
June 1, 2025
4 years
May 9, 2022
June 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in mean 24-hour ambulatory blood pressure
Change in 24-hour ambulatory blood pressure from baseline (pre-treatment) to after taking a stable dose of medication for at least 3 months
Baseline, at least 3 months
Secondary Outcomes (3)
Change in Oculo-Cognitive Addition Test (OCAT) completion time
Baseline, at least 3 months
Change in mean daytime and nighttime 24-hour ambulatory blood pressure
Baseline, at least 3 months
Change in 24-hour ambulatory blood pressure diurnal pattern (dipper versus non-dipper)
Baseline, at least 3 months
Study Arms (3)
Narcolepsy Type 1
Study participant will complete test(s) before and after taking a stable dose of a new/different hypersomnia medication. All hypersomnia medications will be prescribed and titrated by a clinical sleep specialist outside of this protocol.
Narcolepsy Type 2
Study participant will complete test(s) before and after taking a stable dose of a new/different hypersomnia medication. All hypersomnia medications will be prescribed and titrated by a clinical sleep specialist outside of this protocol.
Idiopathic Hypersomnia
Study participant will complete test(s) before and after taking a stable dose of a new/different hypersomnia medication. All hypersomnia medications will be prescribed and titrated by a clinical sleep specialist outside of this protocol.
Interventions
Arm blood pressure cuff that will automatically inflate every 15-30 minutes to check blood pressure while awake and asleep over 24 hours. Patient will also complete a sleep diary and wear an actigraphy watch during this test.
Tracks users' eye movements as they complete a simple mental addition test.
Eligibility Criteria
Patients diagnosed with narcolepsy or idiopathic hypersomnia that have been prescribed but not yet started a new/different hypersomnia medication.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic Arizona
Scottsdale, Arizona, 85259, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chad Ruoff, MD
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 9, 2022
First Posted
May 12, 2022
Study Start
May 18, 2022
Primary Completion
May 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
June 29, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share