Neurophysiologic Correlates of Hypersomnia

University of Wisconsin (UW)

Status: Completed

Conditions: Major Depressive Disorder; Bipolar Disorder; Primary Hypersomnia; Primary Insomnia; Narcolepsy

Treatments: Other: Acoustical slow wave induction

Study type: Observational

Funder types: Other

Identifiers

NCT01719315

2012-0201

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

76 participants in 8 patient groups

MDD with Hypersomnia

Description:

Participants with Major Depressive Disorder and co-morbid hypersomnia

Treatment:

Other: Acoustical slow wave induction

MDD without hypersomnia

Description:

Participants with Major Depressive Disorder but without co-morbid hypersomnia

BPAD with hypersomnia

Description:

Participants with Bipolar Affective Disorder and co-morbid hypersomnia

Treatment:

Other: Acoustical slow wave induction

BPAD without hypersomnia

Description:

Participants with Bipolar Affective Disorder without co-morbid hypersomnia

Primary Hypersomnia

Description:

Patients with primary hypersomnia (idiopathic hypersomnia)

Treatment:

Other: Acoustical slow wave induction

Primary Insomnia

Description:

Patients with primary insomnia

Narcolepsy

Description:

Subjects with narcolepsy

Treatment:

Other: Acoustical slow wave induction

Healthy Controls

Description:

healthy participants