N/A N=44

Challenging the Inflammatory Response System in Insomnia Disorder

Insomnia

Bottom Line

View on ClinicalTrials.gov: NCT02261597 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2019

Primary outcome: Primary: Inflammatory Response to Physiological Challenge- Change in Plasma Levels of IL-6 — 1.5013; 2.1626; 2.5911; 2.7269 pg/mL

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Cold Pressor Test (Behavioral)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Beth Israel Deaconess Medical Center
Primary completion: Jun 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Inflammatory Response to Physiological Challenge- Change in Plasma Levels of IL-6	1.5013; 2.1626; 2.5911; 2.7269; 3.0318; 2.7556	—
PRIMARY Stress Reactivity to Physiological Challenge- Change in Serum Levels of Cortisol	8.9948; 9.8250; 10.6695; 13.95; 8.3255; 11.0416	—
SECONDARY Glucocorticoid Sensitivity- Percentage of IL-6 Positive Monocytes	20.659; 17.250	—

Summary

The main purpose of this study is to understand how insomnia (compared to good sleep) may affect the response of the body to a repeated physiological challenge, such as inserting the hand in ice-cold water for several times in a row. In particular, the investigators are interested in the response of markers that can be associated with stress, such as blood pressure and stress hormones.

Eligibility Criteria

Inclusion Criteria

Women and men between the ages 18-55 years
Blood chemistry in the normal range
BMI less than or equal to 35

Specific to insomnia group:

Diagnosis of insomnia disorder based on DSM-V criteria

Specific for control group:

Good quality and quantity sleep

Exclusion Criteria

Active infection/disease.
History of neurological, chronic pain, immune, cardiovascular, liver/kidney, or metabolic disorder
History of psychiatric disorders within the last 6 months prior to study start
Sleep disorders other than insomnia
Reynaud's disease
Psychotropic, sleep, or any other medications or herbs interfering with the inflammatory, autonomic, or HPA system in the last 2 weeks prior to study start, except oral contraceptives
In psychotherapy or any other behavioral interventions at study start
Donation of blood or platelets within 3 months of hospital visits
Pregnant/nursing.
Substance abuse.

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Data sourced from ClinicalTrials.gov (NCT02261597). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.