Improving the Assessment of Hypersomnolence

NCT ID: NCT02884505

Last Updated: 2019-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

132 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-25

Study Completion Date

2019-06-30

Brief Summary

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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 Description

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Conditions

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Disorders of Excessive Somnolence

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with Hypersomnolence

Patients referred for polysomnography and multiple sleep latency test

Pupillometry

Intervention Type DEVICE

Measures pupillary dynamics in darkness and light conditions

Psychomotor Vigilance Task

Intervention Type BEHAVIORAL

Response time task measuring neurobehavioral alertness

Auditory Evoked Potential

Intervention Type OTHER

Measure of electroencephalographic response to standardized auditory tones

Hypersomnia Severity Index

Intervention Type BEHAVIORAL

Self-report measure of hypersomnolence

Interventions

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Pupillometry

Measures pupillary dynamics in darkness and light conditions

Intervention Type DEVICE

Psychomotor Vigilance Task

Response time task measuring neurobehavioral alertness

Intervention Type BEHAVIORAL

Auditory Evoked Potential

Measure of electroencephalographic response to standardized auditory tones

Intervention Type OTHER

Hypersomnia Severity Index

Self-report measure of hypersomnolence

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David T Plante, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin-Madison, Department of Psychiatry

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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2015-1462

Identifier Type: -

Identifier Source: org_study_id

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