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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Narcolepsy; Idiopathic Hypersomnia
• Intervention / Treatment: Diagnostic test: 24-hour Ambulatory Blood Pressure Monitoring; Diagnostic test: Oculo-Cognitive Addition Test (OCAT)

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 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 sleep specialist as part of routine medical care and covered by subject's health insurance plan (i.e., no medications are dispensed/titrated/paid for by the study investigators/trial).

The 24-hour ambulatory blood pressure test will be setup in person by staff. During the blood pressure test, the study participant will also complete a sleep diary and wear an actigraphy watch to track activity and sleep-wake cycle. The 24-hour ambulatory blood pressure test will be programmed to inflate a blood pressure cuff placed around the arm every 15 - 30 minutes.

The OCAT test, which takes approximately 15-20 minutes to complete, will be completed in person as well.

Each study participant may complete one or both tests. Each study participant may complete more than two assessments (e.g., patient that has been prescribed a second hypersomnia medication). If a patient presents already taking a medication of interest at baseline for at least the last 3 months then the participant may undergo baseline assessment(s) while taking respective medication(s).

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with narcolepsy or idiopathic hypersomnia that have been prescribed but not yet started a new/different hypersomnia medication.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: 24-hour Ambulatory Blood Pressure Monitoring; 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.; Other Names: Actigraphy; Sleep diary; Diagnostic test: Oculo-Cognitive Addition Test (OCAT); Tracks users' eye movements as they complete a simple mental addition test.
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.	Diagnostic test: 24-hour Ambulatory Blood Pressure Monitoring; 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.; Other Names: Actigraphy; Sleep diary; Diagnostic test: Oculo-Cognitive Addition Test (OCAT); Tracks users' eye movements as they complete a simple mental addition test.
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.	Diagnostic test: 24-hour Ambulatory Blood Pressure Monitoring; 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.; Other Names: Actigraphy; Sleep diary; Diagnostic test: Oculo-Cognitive Addition Test (OCAT); Tracks users' eye movements as they complete a simple mental addition test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Oculo-Cognitive Addition Test (OCAT) completion time	Change in OCAT completion time from baseline (pre-treatment) to after taking a stable dose of medication for at least 3 months (post-treatment)	Baseline, at least 3 months
Change in mean daytime and nighttime 24-hour ambulatory blood pressure	Change in mean daytime and nighttime 24-hour ambulatory blood pressure from baseline (pre-treatment) to after taking a stable dose of medication for at least 3 months (post-treatment)	Baseline, at least 3 months
Change in 24-hour ambulatory blood pressure diurnal pattern (dipper versus non-dipper)	Change in 24-hour ambulatory blood pressure diurnal pattern (dipper versus non-dipper) from baseline (pre-treatment) to after taking a stable dose of medication for at least 3 months (post-treatment)	Baseline, at least 3 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Chad Ruoff, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2022
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: May 9, 2022
• First Submitted That Met QC Criteria: May 9, 2022
• First Posted (Actual): May 12, 2022

Study Record Updates

• Last Update Posted (Estimated): June 2, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Blood pressure; Cognitive function; narcolepsy; idiopathic hypersomnia; Central Disorders of Hypersomnolence
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disorders of Excessive Somnolence; Narcolepsy; Idiopathic Hypersomnia
• Other Study ID Numbers: 21-013321

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No