Neurophysiologic Correlates of Hypersomnia

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Wisconsin, Madison
Sponsor:
Information provided by (Responsible Party):
David Plante, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01719315
First received: October 24, 2012
Last updated: May 13, 2014
Last verified: May 2014

October 24, 2012
May 13, 2014
November 2012
June 2018   (final data collection date for primary outcome measure)
Nocturnal Slow Wave Activity [ Time Frame: Individual nights of sleep recorded within an average of 4 weeks of enrollment ] [ Designated as safety issue: No ]
EEG recordings during sleep will be analyzed to assess slow wave activity in the 1-4.5Hz range.
Same as current
Complete list of historical versions of study NCT01719315 on ClinicalTrials.gov Archive Site
Waking theta/alpha activity [ Time Frame: Individual days of waking EEG will be recorded within an average of 4 weeks of enrollment ] [ Designated as safety issue: No ]
Waking EEG activity across the 1-12Hz range will be analyzed.
Same as current
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Neurophysiologic Correlates of Hypersomnia
Neurophysiologic Correlates of Hypersomnia: a High Density EEG Investigation

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

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.

  • Major Depressive Disorder
  • Primary Hypersomnia
  • Bipolar Disorder
  • Narcolepsy
  • Primary Insomnia
Other: Acoustical slow wave induction
Brief tones (50 millisecond duration) at a frequency of 0.8 and 2 Hz, a rate that approximates the natural cellular oscillations of cortical neurons during sleep, will be played in blocks of 15-20 during non-rapid eye movement (NREM) sleep. Blocks of active acoustic slow wave induction will be followed by blocks of equal duration without induction, in order to make comparisons between stimulation periods (ON) and no stimulation periods (OFF). Tone intensity will be manually adjusted so as to be above an individual participant's auditory threshold during waking, but still quiet enough as not to awaken the subject from sleep. Sham slow wave induction will consist of auditory tones played prior to sleep, and during sleep of insufficient timing and intensity to alter slow wave activity.
  • MDD with Hypersomnia
    Participants with Major Depressive Disorder and co-morbid hypersomnia
    Intervention: Other: Acoustical slow wave induction
  • MDD without hypersomnia
    Participants with Major Depressive Disorder but without co-morbid hypersomnia
  • BPAD with hypersomnia
    Participants with Bipolar Affective Disorder and co-morbid hypersomnia
    Intervention: Other: Acoustical slow wave induction
  • BPAD without hypersomnia
    Participants with Bipolar Affective Disorder without co-morbid hypersomnia
  • Primary Hypersomnia
    Patients with primary hypersomnia (idiopathic hypersomnia)
    Intervention: Other: Acoustical slow wave induction
  • Primary Insomnia
    Patients with primary insomnia
  • Narcolepsy
    Subjects with narcolepsy
    Intervention: Other: Acoustical slow wave induction
  • Healthy Controls
    healthy participants
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
June 2018
June 2018   (final data collection date for primary outcome measure)

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.

Both
18 Years to 60 Years
Yes
Contact: David T Plante, MD 608-262-0130 plantelab@mailplus.wisc.edu
United States
 
NCT01719315
2012-0201
No
David Plante, University of Wisconsin, Madison
University of Wisconsin, Madison
Not Provided
Principal Investigator: David T Plante University of Wisconsin, Madison
University of Wisconsin, Madison
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP