Does Narcolepsy/Idiopathic Hypersomnia and Their Treatment(s) Alter Blood Pressure and Cognition

Overview

About this study

The objectives of this study are to demonstrate that patients with CNS hypersomnias exhibit cardiovascular and cognitive disturbances, and to demonstrate that CNS medications medications impact these cardiovascular and cognitive disturbances.

 

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Diagnosed with a CNS hypersomnia according to ICSD-3 classifications.
  • Age 18 - 75 years.
  • BMI between 18 and 40 kg/m^2.
  • Prescribed a medication of interest (e.g., sodium oxybate, low sodium oxybate, pitolisant, modafinil/armodafinil, solriamfetol) by a clinical sleep specialist as part of routine medical care and covered by subject’s health insurance plan.
  • If subject has not yet started the prescribed medication, then subject must be willing to postpone starting medication until after completion of baseline assessment(s).
  • If subject has been taking a prescribed medication at a stable dose for at least 3 months and has been prescribed a new medication, then then subject may complete baseline assessment(s) while taking initial medication 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.                     

Eligibility last updated 4/28/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Chad Ruoff, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Chad Ruoff M.D.

(480) 342-1019

Ruoff.Chad@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

Virend Somers, M.D., Ph.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Chad Ruoff M.D.

(480) 342-1019

Ruoff.Chad@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20531378

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