Neurophysiologic Correlates of Hypersomnia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Major Depressive Disorder Bipolar Disorder Bipolar and Related Disorders Depressive Disorder Depressive Disorder, Major Disorders of Excessive Somnolence Dyssomnias Idiopathic Hypersomnia Mental Disorders Mood Disorders Narcolepsy Nervous System Diseases Primary Hypersomnia Primary Insomnia Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Wisconsin-Madison, Department of Psychiatry

Madison, Wisconsin, 53719, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acoustical slow wave induction

Other

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.

Primary outcomes

Nocturnal Slow Wave Activity

Time frame: 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 outcomes

Waking theta/alpha activity

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

Neurophysiologic Correlates of Hypersomnia: a High Density EEG Investigation

Important dates

Study start: 2012
Primary completion: 2018
Study completion: 2018
First posted: Nov 1, 2012
Registry last updated: Dec 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed