Challenging the Inflammatory Response System in Insomnia Disorder



Status:Active, not recruiting
Conditions:Insomnia Sleep Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:25 - 50
Updated:1/27/2018
Start Date:January 2015
End Date:December 2018

Use our guide to learn which trials are right for you!

Challenging the Inflammatory Response System: Are Individuals With Insomnia More Reactive?

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.

Sleep is critical for the regulation and maintenance of biological systems, and sleep
deficiency, such as insomnia, has been shown to be associated with elevated risks for
cardiovascular, metabolic, and mood disorders.

Despite the high prevalence of insomnia in the population, the investigators understanding of
the biological consequences of the disorder with respect to inflammatory, autonomic, and
stress system markers is limited, and often not consistent.

In addition, insomnia may not only alter the basal activity of these systems, but may change
their reactivity to other stressors and challenges. In support of this assumption are
findings showing that poor sleep quality in healthy individuals is associated with a stronger
biological response to a stressful challenge, such as the cold pressor test. This test
involves the immersion of the hand in ice-cold water. It is one of the most commonly used
laboratory physiological challenge tests, provoking not only unpleasantness, but also
increases in stress and inflammatory markers.

Investigations of such system's reactivity to challenge may elucidate systems abnormalities
that the investigators do not capture by only assessing basal system's levels. For example,
in patients with rheumatoid arthritis, basal inflammatory levels are normal, but the response
to a physiological stress challenge (cold pressor test) is amplified.

To the investigators knowledge, no studies have measured how insomnia may affect the
reactivity of biological systems to a stressful challenge, which may serve as an important
indicator of system's dysregulation and associated disease risk.

In this light, the primary goal of this proposal will investigate whether stress-related
systems are more reactive to a physiological stressful challenge in insomnia disorder
compared to healthy controls.

Inclusion Criteria:

- Women and men between the ages 25-50 years

- Blood chemistry in the normal range

Specific to insomnia group:

- Diagnosis of insomnia disorder

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

- Sleep disorders other than insomnia

- Reynaud's disease

- In psychotherapy or any other behavioral interventions at study start

- Pregnant/nursing.

- Substance abuse.
We found this trial at
1
site
Boston, Massachusetts 02215
?
mi
from
Boston, MA
Click here to add this to my saved trials