Improving the Assessment of Hypersomnolence

Completed

• Conditions: Disorders of Excessive Somnolence
• Interventions: Device: Pupillometry; Behavioral: Psychomotor Vigilance Task; Other: Auditory Evoked Potential; Behavioral: Hypersomnia Severity Index

• Registration Number: NCT02884505
• Lead Sponsor: University of Wisconsin, Madison

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 Description

Not available

Study Timeline

• Study First Submitted: 2016-08-16
• Study First Submitted QC: 2016-08-25
• Study First Posted: 2016-08-31
• Study Start: 2017-08-25
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-20
• Last Update Posted: 2019-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Hypersomnolence	Psychomotor Vigilance Task	Patients referred for polysomnography and multiple sleep latency test
Patients with Hypersomnolence	Hypersomnia Severity Index	Patients referred for polysomnography and multiple sleep latency test
Patients with Hypersomnolence	Pupillometry	Patients referred for polysomnography and multiple sleep latency test
Patients with Hypersomnolence	Auditory Evoked Potential	Patients referred for polysomnography and multiple sleep latency test

Primary Outcome Measures

Name	Time	Method
Proportion of Patients Categorized with Hypersomnolence	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.

Trial Locations

Locations (1)

University of Wisconsin-Madison, Department of Psychiatry; 🇺🇸 Madison, Wisconsin, United States