Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05371483
Study type Observational
Source Mayo Clinic
Contact
Status Enrolling by invitation
Phase
Start date May 18, 2022
Completion date July 2026

See also
  Status Clinical Trial Phase
Completed NCT04072380 - A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy Phase 2
Withdrawn NCT03626727 - Evaluation of the Efficacy of Sodium Oxybate (Xyrem®) in Treatment of Post-traumatic Narcolepsy and Post-traumatic Hypersomnia Early Phase 1
Completed NCT02821715 - Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients Phase 2
Completed NCT01681121 - A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy Phase 2
Completed NCT01789398 - Patient Narcoleptic Treated With BF2.649 (Pitolisant) in add-on to Sodium Oxybate (HARMONY IV) Phase 3
Completed NCT00174174 - Provigil (Modafinil) Study by Taiwan Biotech Co. N/A
Completed NCT05059223 - A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy Phase 3
Completed NCT04923594 - Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy Phase 2
Recruiting NCT06279247 - Proteomics and Metabolomics of Body Fluid in Patients With Narcolepsy
Completed NCT04647903 - Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation (ADAIR) Phase 1
Completed NCT03267303 - A Study to Evaluate the Safety and Efficacy of TS-091 in Patients With Narcolepsy Phase 2
Completed NCT03173378 - Evaluation of Academic and Professional Trajectories of Narcoleptic Patients
Completed NCT05055024 - An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy Phase 2
Completed NCT01067235 - Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy Phase 3
Completed NCT00228566 - Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome Phase 3
Completed NCT00107796 - Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy Phase 3
Completed NCT00132873 - Trial of Xyrem® (Sodium Oxybate) for the Treatment of Narcolepsy Phase 3
Completed NCT00107848 - PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome Phase 3
Enrolling by invitation NCT05113745 - A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy Phase 3
Suspended NCT04419792 - 'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy'