Improving the Assessment of Hypersomnolence

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Completed
• CT.gov ID: NCT02884505
• Collaborator: (none)
• Enrollment: 132
• Location: 1
• Actual Duration (Months): 22.1
• Patients Per Site Per Month: 6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Disorders of Excessive Somnolence	Device: Pupillometry; Behavioral: Psychomotor Vigilance Task; Other: Auditory Evoked Potential; Behavioral: Hypersomnia Severity Index

Study Design

• Study Type: Observational
• Actual Enrollment: 132 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Improving the Assessment of Hypersomnolence
• Actual Study Start Date: Aug 25, 2017
• Actual Primary Completion Date: Jun 30, 2019
• Actual Study Completion Date: Jun 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Patients with Hypersomnolence Patients referred for polysomnography and multiple sleep latency test	Device: Pupillometry; Measures pupillary dynamics in darkness and light conditions; Behavioral: Psychomotor Vigilance Task; Response time task measuring neurobehavioral alertness; Other: Auditory Evoked Potential; Measure of electroencephalographic response to standardized auditory tones; Behavioral: Hypersomnia Severity Index; Self-report measure of hypersomnolence

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 89 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Wisconsin-Madison, Department of Psychiatry	Madison	Wisconsin	United States	53719

Sponsors and Collaborators

• University of Wisconsin, Madison

Investigators

• Principal Investigator: David T Plante, MD, University of Wisconsin, Madison

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT02884505
• Other Study ID Numbers: 2015-1462
• First Posted: Aug 31, 2016
• Last Update Posted: Aug 22, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Disorders of Excessive Somnolence; Sleepiness

Study Results

No Results Posted as of Aug 22, 2019