Improving the Assessment of Hypersomnolence
1 other identifier
observational
132
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2016
CompletedFirst Posted
Study publicly available on registry
August 31, 2016
CompletedStudy Start
First participant enrolled
August 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedAugust 22, 2019
August 1, 2019
1.8 years
August 16, 2016
August 20, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
2 Years
Study Arms (1)
Patients with Hypersomnolence
Patients referred for polysomnography and multiple sleep latency test
Interventions
Measures pupillary dynamics in darkness and light conditions
Response time task measuring neurobehavioral alertness
Measure of electroencephalographic response to standardized auditory tones
Self-report measure of hypersomnolence
Eligibility Criteria
Patients referred for polysomnography and multiple sleep latency test at the University of Wisconsin-Madison
You may qualify if:
- 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
You may not qualify if:
- unstable medical condition that, in the opinion of the investigators, would make it unsafe for the subject to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Wisconsin-Madison, Department of Psychiatry
Madison, Wisconsin, 53719, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David T Plante, MD
University of Wisconsin, Madison
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2016
First Posted
August 31, 2016
Study Start
August 25, 2017
Primary Completion
June 30, 2019
Study Completion
June 30, 2019
Last Updated
August 22, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share