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Primary Insomnia | A High Density EEG Comparison of Sleep Patterns in Insomnia

Primary Insomnia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Primary Insomnia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:Serial awakeningsThe 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Primary insomnia

Healthy sleeping controls

Study Status

Recruiting

Start Date: October 2013

Completed Date: July 2017

Phase: N/A

Type: Observational

Design:

Primary Outcome: Topographic sleep EEG power

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Ruth M Benca, MD, PhD

Lead Sponsor: University of Wisconsin, Madison

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01960452

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