Neurophysiologic Correlates of Hypersomnia

Completed

• Conditions: Bipolar Disorder; Narcolepsy; Major Depressive Disorder; Primary Insomnia; Primary Hypersomnia

• Registration Number: NCT01719315
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

The goal of this project is to examine the neurophysiology of hypersomnia during sleep and wakefulness, to identify biomarkers for excessive sleepiness in neuropsychiatric disorders, and pilot acoustical slow wave induction during sleep in patients with hypersomnolence, to determine if this decreases daytime sleepiness in these patients. The primary study hypotheses are that individuals with hypersomnolence will have reduced slow wave activity (SWA) during sleep and increased waking theta/alpha activity during wake in specific brain regions. A secondary hypothesis is that acoustical slow wave induction in hypersomnolent patients will increase SWA during sleep, reduce theta/alpha activity during wake, and improve subjective sleepiness.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-24
• Study First Submitted QC: 2012-10-29
• Study Start: 2012-11
• Study First Posted: 2012-11-01
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-21
• Last Update Posted: 2018-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• Meet Diagnostic and Statistical Manual edition IV criteria for neuropsychiatric disorders enumerated in study population description

Exclusion Criteria

Exclusionary criteria for all subjects will include: evidence of a clinically significant sleep disorder that would cause hypersomnolence (e.g. moderate to severe obstructive sleep apnea, restless legs syndrome, shift-work sleep disorder), history of significant head trauma or loss of consciousness > 30 minutes; current smoking of more than 15 cigarettes per day; >3 caffeinated beverages per day; significant neurologic or medical illness; active drug/alcohol abuse/dependence (within 6 months of enrollment), women who are pregnant, <6 months post-partum, nursing or planning to become pregnant during the study; left-handedness (due to effects on sleep topography); and imminent risk for self-harm or suicide.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Nocturnal Slow Wave Activity	Individual nights of sleep recorded within an average of 4 weeks of enrollment	EEG recordings during sleep will be analyzed to assess slow wave activity in the 1-4.5Hz range.

Secondary Outcome Measures

Name	Time	Method
Waking theta/alpha activity	Individual days of waking EEG will be recorded within an average of 4 weeks of enrollment	Waking EEG activity across the 1-12Hz range will be analyzed.

Trial Locations

Locations (1)

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