A High Density EEG Comparison of Sleep Patterns in Insomnia

Study Overview
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Brief Summary
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Insomnia, defined as a subjective report of difficulty initiating sleep, maintaining sleep, and/or non-restorative sleep, leads to significant daytime dysfunction and increased health risks. A commonly held hypothesis is that insomnia is caused by a state of hyperarousal, but the neurobiological mechanisms of hyperarousal in insomnia are poorly understood, in part because of limitations in our ability to image the brain during normal human sleep with sufficient temporal resolution. Furthermore, the efficacy of insomnia treatment is judged by subjective report of the patient and demonstration of changes in sleep latency and/or sleep amount which are generally small in magnitude; there are currently no data to demonstrate that insomnia treatments correct any functional abnormalities in the sleep process that likely contribute to neurobehavioral abnormalities and health risks. The goals of the proposed study are to use high density EEG to define abnormalities in specific aspects of sleep in insomnia patients compared to healthy sleeping control subjects to define biomarkers that will both increase our understanding of the pathophysiology of insomnia as well as provide targets to assess treatments for insomnia.

Official Title
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A High Density EEG Comparison of Sleep, Sleep Initiation, and Arousal Patterns in Insomnia Patients and Normal Controls

Conditions
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Primary Insomnia

Intervention / Treatment
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* Behavioral: Serial awakenings


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-45 years old English speaking, reading, and writing For control subjects: Insomnia Severity Index (ISI) less than or equal to 6 and does not meet criteria for insomnia For insomnia subjects: ISI greater than or equal to 7, meets criteria for insomnia, and reports insomnia symptoms for at least 6 months Exclusion Criteria: Imminent danger to self or others Clinical diagnosis of dementia Active Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV Axis I disorder or alcohol or drug dependence or abuse Other sleep disorders aside from insomnia History of significant head trauma or loss of consciousness over 30 minutes Regular use of psychotropic medications in past 4 weeks Regular tobacco use Drinking more than 3 caffeinated beverages per day Significant neurological or medical illness Pregnant, less than 6 months post-partum, or planning to become pregnant during the study Left-handedness Body Mass Index (BMI) greater than 40 Apnea Hypopnea Index (AHI) greater than 10 on Apnea Link Mini mental status exam score less than 27

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary insomnia<br> | Behavioral: Serial awakenings<br>* The first study night will be a baseline sleep recording. The second night will consist of a series of awakenings (using auditory tones) and subsequent periods of falling back asleep in order to examine the cortical dynamics of hyperarousal or other dysfunction during these two critical sleep processes in insomnia.<br>|
| Healthy sleeping controls<br> | Behavioral: Serial awakenings<br>* The first study night will be a baseline sleep recording. The second night will consist of a series of awakenings (using auditory tones) and subsequent periods of falling back asleep in order to examine the cortical dynamics of hyperarousal or other dysfunction during these two critical sleep processes in insomnia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Topographic sleep EEG power | EEG recordings will be analyzed to assess the cortical source of EEG power during sleep . | Individual night of sleep recorded on average within 4 weeks of enrollment | 
| Topographic EEG power prior to nocturnal arousal | EEG power examined before arousal from sleep | 1 night after baseline sleep EEG recording | 
| Topographic EEG power during falling asleep period | EEG power examined as subjects fall asleep | 1 night after baseline sleep EEG recording | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Primary insomnia, High density EEG, Polysomnography, Healthy sleeping controls