Neurophysiologic Correlates of Hypersomnia

NCT01719315 | Completed

• 1 other identifier: 2012-0201
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Waking theta/alpha activity

  Individual days of waking EEG will be recorded within an average of 4 weeks of enrollment

Study Arms (8)

MDD with Hypersomnia

Participants with Major Depressive Disorder and co-morbid hypersomnia

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

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)

Other: Acoustical slow wave induction

Primary Insomnia

Patients with primary insomnia

Narcolepsy

Subjects with narcolepsy

Other: Acoustical slow wave induction

Healthy Controls

healthy participants

Interventions

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.

BPAD with hypersomnia; MDD with Hypersomnia; Narcolepsy; Primary Hypersomnia

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Meet Diagnostic and Statistical Manual edition IV criteria for neuropsychiatric disorders enumerated in study population description

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin-Madison, Department of Psychiatry

Madison, Wisconsin, 53719, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Idiopathic Hypersomnia; Bipolar Disorder; Narcolepsy; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Bipolar and Related Disorders

Study Officials

• David T Plante

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2012
• First Posted: November 1, 2012
• Study Start: November 1, 2012
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: December 24, 2018

Record last verified: 2018-12

Locations

US (1)