Clinical Trial: Improving the Assessment of Hypersomnolence

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title: Improving the Assessment of Hypersomnolence

Brief Summary: The overall purpose of this study is to employ a pragmatic, multidimensional assessment of hypersomnolence that "piggybacks" on routine clinical care in patients with suspected disorders of central nervous system (CNS) hypersomnia, to determine whether these additional objective and subjective assessments are useful in the diagnosis and management of these patients.

Detailed Summary:
Sponsor: University of Wisconsin, Madison

Current Primary Outcome: Proportion of Patients Categorized with Hypersomnolence [ Time Frame: 2 Years ]

Multiple measurements will be aggregated to arrive at the primary outcome of proportion of patients categorized as having hypersomnolence using either standard assessments or standard assessments plus additional novel hypersomnolence measures of pupillometry, psychomotor vigilance task, and auditory evoked potentials. Proportion of patients with hypersomnolence using standard measures will be calculated as number of patients with mean sleep latency (MSL) on multiple sleep latency test (MSLT) <8 minutes divided by total number of patients. Proportion of patients categorized as having hypersomnolence with additional novel hypersomnolence measures will be calculated as the number of patients with MSL<8 minutes, and/or pupillary unrest index (PUI) >8.9 on pupillometry, and/or PVT lapses >3, and/or P300 delay/sleep negativity during auditory evoked potentials divided by total number of patients.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Wisconsin, Madison

Dates:
Date Received: August 16, 2016
Date Started: August 2016
Date Completion:
Last Updated: November 30, 2016
Last Verified: November 2016