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OpenTrials
Completed

NCT Number: NCT02884505

Improving the Assessment of Hypersomnolence

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.

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Key information

Conditions

Disorders of Excessive Somnolence Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Wisconsin-Madison, Department of Psychiatry

Madison, Wisconsin, 53719, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pupillometry

Device

Measures pupillary dynamics in darkness and light conditions

Psychomotor Vigilance Task

Behavioral

Response time task measuring neurobehavioral alertness

Auditory Evoked Potential

Other

Measure of electroencephalographic response to standardized auditory tones

Hypersomnia Severity Index

Behavioral

Self-report measure of hypersomnolence

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 31, 2016
Registry last updated
Aug 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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