Challenging the Inflammatory Response System in Insomnia Disorder

NCT ID: NCT02261597

Last Updated: 2019-07-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 44 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2018-03-31

Brief 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.

Detailed Description

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.

Conditions

Insomnia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Insomnia Disorder

Testing reactivity of stress-related systems to repeated exposure to the cold pressor test (hand immersion into ice-cold water) among participants with a clinical diagnosis of insomnia disorder.

Cold Pressor Test

Intervention Type: BEHAVIORAL

Repeated immersion of hand in ice-cold water

Healthy Control

Testing reactivity of stress-related systems to repeated exposure to the cold pressor test (hand immersion into ice-cold water) among healthy participants without a diagnosis of insomnia disorder.

Cold Pressor Test

Intervention Type: BEHAVIORAL

Repeated immersion of hand in ice-cold water

Interventions

Cold Pressor Test

Repeated immersion of hand in ice-cold water

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Monika Haack

Assistant Professor of Neurology HMS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Haack Monika, PhD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

BIDMC

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2014P000297

Identifier Type: -

Identifier Source: org_study_id