A High Density EEG Comparison of Sleep Patterns in Insomnia

Primary Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01960452
• Other study ID #: 2013-1613
• Secondary ID: HSC-2013-0019
• Status: Completed
• Phase: N/A
• First received: October 4, 2013
• Last updated: December 15, 2017
• Start date: October 2013
• Est. completion date: September 2017

Study information

• Verified date: December 2017
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Primary Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Wisconsin, Madison	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Topographic EEG power prior to nocturnal arousal	EEG power examined before arousal from sleep	1 night after baseline sleep EEG recording
Primary	Topographic EEG power during falling asleep period	EEG power examined as subjects fall asleep	1 night after baseline sleep EEG recording