Improving the Assessment of Hypersomnolence

Disorders of Excessive Somnolence Clinical Trial

Official title:

Improving the Assessment of Hypersomnolence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02884505
• Other study ID #: 2015-1462
• Status: Completed
• Start date: August 25, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: August 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Disorders of Excessive Somnolence
• Sleepiness

Intervention

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

Locations

Country	Name	City	State
United States	University of Wisconsin-Madison, Department of Psychiatry	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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