Clinical Trials Directory

Trials / Completed

CompletedNCT01719315

Neurophysiologic Correlates of Hypersomnia

Neurophysiologic Correlates of Hypersomnia: a High Density EEG Investigation

Status
Completed
Phase
Study type
Observational
Enrollment
76 (actual)
Sponsor
University of Wisconsin, Madison · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERAcoustical slow wave inductionBrief 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.

Timeline

Start date
2012-11-01
Primary completion
2018-06-01
Completion
2018-06-01
First posted
2012-11-01
Last updated
2018-12-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01719315. Inclusion in this directory is not an endorsement.