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Completed

NCT Number: NCT02261597

Challenging the Inflammatory Response System in Insomnia Disorder

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

BIDMC

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cold pressor test

Behavioral

Repeated immersion of hand in ice-cold water

Primary outcomes

  1. Inflammatory Response to Physiological Challenge- Change in Plasma Levels of IL-6

    Time frame: Baseline blood was obtained between 11am-12pm and prior to any Cold Pressor Tests (CPTs). Three CPTs were performed, with 1.5 hours between each one. The first CPT was done at 1pm. Blood draws were obtained 20min and 50 min after each CPT.

    Inflammatory marker: Change in plasma levels of IL-6 (pg/mL).

  2. Stress Reactivity to Physiological Challenge- Change in Serum Levels of Cortisol

    Time frame: Baseline blood was obtained between 11am-12pm and prior to any Cold Pressor Tests (CPTs). Three CPTs were performed, with 1.5 hours between each one. The first CPT was done at 1pm. Blood draws were obtained 20min and 50 min after each CPT.

    HPA marker: Change in serum cortisol levels (ug/dL)

Secondary outcomes

  1. Glucocorticoid Sensitivity- Percentage of IL-6 Positive Monocytes

    Time frame: Monocytes are only obtained from the baseline blood draw, which occurs at 11am.

    Percentage of IL-6 positive monocytes following stimulation with LPS (100pg/mL) and varying concentrations of Dexamethasone

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Oct 10, 2014
Registry last updated
Jul 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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