Hyper-Arousal in Chronic Primary Insomnia

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-12-20

Brief Summary

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The purpose of this study is to determine whether individuals with chronic insomnia disorder have a higher degree of physiologic arousal (resulting in their trouble sleeping) than good sleepers. The primary goal is to perform a rigorous quantitative assessment of physiologic hyper-arousal across two domains (autonomic nervous system and neurophysiology) in patients with chronic primary insomnia as compared to good sleepers matched for sex, age, body mass index (BMI) and race/ethnicity.

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Detailed Description

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Conditions

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Chronic Insomnia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Insomnia group

Assessment of physiologic hyper-arousal across the two following domains:

1. Sympathetic neural activity: recording at the level of the muscle by microneurography and at the level of the heart by spectral analysis of heart rate variability from the ECG signal obtained during sleep and wakefulness.
2. Neurophysiologic arousal: recording of multiple sleep latency test (MSLT), recording of wake electroencephalography (EEG), and quantitative sleep EEG recording and analysis.

No interventions assigned to this group

Matched Control Group

Assessment of physiologic hyper-arousal across the two following domains:

1. Sympathetic neural activity: recording at the level of the muscle by microneurography and at the level of the heart by spectral analysis of heart rate variability from the ECG signal obtained during sleep and wakefulness.
2. Neurophysiologic arousal: recording of multiple sleep latency test (MSLT), recording of wake electroencephalography (EEG), and quantitative sleep EEG recording and analysis.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Men and women with primary insomnia of at least 3 months in duration
* ages 21-65 years old
* BMI \<35 kg/m2 to enable microneurography
* Moderate to severe insomnia based on the Insomnia Severity Index (ISI) questionnaire
* Pittsburgh Sleep Quality Index (PSQI) \> 5
* Self-reported habitual sleep duration \< 6.5 hours

* 21-65 years old men and women with BMI \<35 kg/m2
* No insomnia based on ISI questionnaire
* Self-reported habitual sleep duration ≥ 6.5 hours but \< 9 hours
* PSQI\<5
* Sleep efficiency on PSG with TRT of 8 hours \> 85%
* No history of mental illness, shift work, circadian rhythm disorders

Exclusion Criteria

* Sleep disorders other than insomnia as assessed by screening PSG (apnea-hypopnea index or AHI ≥ 10, PLM arousal index ≥ 5)
* Circadian rhythm sleep disorders
* Diabetic based on HbA1c ≥ 6.5 %. For those with HbA1c ≥ 6.0 but \<6.5%, the non-diabetic condition will be confirmed by 2-h oral glucose tolerance test
* History of meeting DSM-IVR criteria based on the Mini International Neuropsychiatric Interview version 6.0 for any major psychiatric disorder
* Unstable or serious medical conditions
* Current, or use within the past month, of psychoactive (other than stable treatment with antidepressants), hypnotic, stimulant or analgesic medications (except occasional non-narcotic analgesics), beta blockers or alpha blockers
* Shift work or other types of self imposed irregular sleep schedules
* Habitual smoking
* Habitual alcohol consumption
* Pregnancy

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes