A High Density EEG Comparison of Sleep Patterns in Insomnia

NCT ID: NCT01960452

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2017-09-30

Brief Summary

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.

Detailed Description

Recent advances in electroencephalographic recording techniques have produced new ways to probe the process and function of sleep. Through the use of high-density EEG (hdEEG, up to 256 channels), it is possible to approach the spatial resolution of other brain imaging modalities while affording the millisecond temporal resolution of EEG and providing a direct measure of the underlying brain activity, unlike the indirect and/or secondary biophysical signals of brain hemodynamics/metabolism obtained with PET or SPECT that are suboptimal for exploring the short-lived spatio-temporal dynamics of many brain processes.

Here we used hdEEG to try to characterize topographic changes in sleep EEG expression in individuals with insomnia compared to normal controls. We further used serial awakenings to determine if individuals with insomnia were more likely to subjectively report being awake when they were sleeping, and study instances where a direct confirmation of sleep was followed by a subjective report of wakefulness to see if they are characterized by changes in EEG oscillations.

Conditions

Primary Insomnia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Primary insomnia

Participants classified as having insomnia through clinical interview, questionnaires, actigraphy, and sleep log data as well as meeting other eligibility criteria.

Serial awakenings

Intervention Type: BEHAVIORAL

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.

Healthy sleeping controls

Participants classified as having healthy sleepy through clinical interview, questionnaires, actigraphy, and sleep log data as well as meeting other eligibility criteria.

Serial awakenings

Intervention Type: BEHAVIORAL

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.

Interventions

Serial awakenings

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Meredith E Rumble, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin, Madison

Madison, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HSC-2013-0019

Identifier Type: OTHER

Identifier Source: secondary_id

2013-1613

Identifier Type: -

Identifier Source: org_study_id