Improving the Assessment of Hypersomnolence

University of Wisconsin, Madison132 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

132

Conditions

Disorders of Excessive Somnolence

Interventions

PupillometryDEVICE

Measures pupillary dynamics in darkness and light conditions

Psychomotor Vigilance TaskBEHAVIORAL

Response time task measuring neurobehavioral alertness

Auditory Evoked PotentialOTHER

Measure of electroencephalographic response to standardized auditory tones

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18-89 * Referred for polysomnography/multiple sleep latency test at Wisconsin Sleep, the sleep medicine clinic and laboratory of the University of Wisconsin-Madison Exclusion Criteria: * unstable medical condition that, in the opinion of the investigators, would make it unsafe for the subject to participate

Locations (1)

University of Wisconsin-Madison, Department of Psychiatry

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Proportion of Patients Categorized with Hypersomnolence

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.

Time frame: 2 Years

Data from ClinicalTrials.gov

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