Neurophysiologic Correlates of Hypersomnia

Major Depressive Disorder Clinical Trial

Official title:

Neurophysiologic Correlates of Hypersomnia: a High Density EEG Investigation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01719315
• Other study ID #: 2012-0201
• Status: Completed
• Start date: November 2012
• Est. completion date: June 2018

Study information

• Verified date: December 2018
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Disorders of Excessive Somnolence
• Major Depressive Disorder
• Narcolepsy
• Primary Hypersomnia
• Primary Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	University of Wisconsin-Madison, Department of Psychiatry	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

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