Major Depressive Disorder Clinical Trial
Official title:
Neurophysiologic Correlates of Hypersomnia: a High Density EEG Investigation
NCT number | NCT01719315 |
Other study ID # | 2012-0201 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 2012 |
Est. completion date | June 2018 |
Verified date | December 2018 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 76 |
Est. completion date | June 2018 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin-Madison, Department of Psychiatry | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nocturnal Slow Wave Activity | EEG recordings during sleep will be analyzed to assess slow wave activity in the 1-4.5Hz range. | Individual nights of sleep recorded within an average of 4 weeks of enrollment | |
Secondary | Waking theta/alpha activity | Waking EEG activity across the 1-12Hz range will be analyzed. | Individual days of waking EEG will be recorded within an average of 4 weeks of enrollment |
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