Clinical trial NCT01719315: Neurophysiologic Correlates of Hypersomnia
Official title: Neurophysiologic Correlates of Hypersomnia: a High Density EEG Investigation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depressive Disorder
Primary Hypersomnia
Bipolar Disorder
Narcolepsy
Primary Insomnia
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2012-11-01
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from the greater Madison, WI area. Hypersomnolent subject groups (n=30 in each group) may include unipolar MDD with hypersomnolence, primary hypersomnia (idiopathic hypersomnia), bipolar disorder with hypersomnolence, and narcolepsy. Non-hypersomnolent comparison groups (n=30 in each group) will include: MDD without hypersomnolence, bipolar disorder without hypersomnolence, primary insomnia, and healthy controls.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Nocturnal Slow Wave Activity
timeFrame: Individual nights of sleep recorded within an average of 4 weeks of enrollment
Secondary outcomes:
measure: Waking theta/alpha activity
timeFrame: Individual days of waking EEG will be recorded within an average of 4 weeks of enrollment
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison, Department of Psychiatry
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: David T Plante
role: PRINCIPAL_INVESTIGATOR
References: